Back to resultsAnterior Pituitary Hormone Replacement in Traumatic Brain Injury
Primary Purpose
Growth Hormone Deficiency, Traumatic Brain Injury
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Recombinant human growth hormone
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency focused on measuring TBI, Traumatic Brain injury, Growth hormone deficiency, Anterior pituitary hormone, Recombinant human growth Hormone, Genotropin
Eligibility Criteria
Inclusion Criteria:
- Patients aged 21 and older.
- Documented moderate to severe traumatic brain injury at least one year post injury.
Exclusion Criteria:
- The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
- Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
- Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
- Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Sites / Locations
- Transitional Learning Center
- The University of Texas Medical Branch at Galveston
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Human Growth Hormone
Arm Description
recombinant human growth hormone (rhGH) self administered daily for one year
Outcomes
Primary Outcome Measures
Maximum Oxygen Uptake at Baseline.
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Minute Ventilation at Baseline.
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Respiratory Exchange Ratio at Baseline.
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Oxygen Pulse at Baseline.
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Secondary Outcome Measures
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Digit Span Total at Baseline
Digit Span; Wechsler Memory Scale III (WMS III).
Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Neuropsychological Function as Measured by Processing Speed Index at Baseline
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.
This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.
Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.
This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.
Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Neuropsychological Function as Measured by Letter Fluency at Baseline
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Depression as Measured by the Beck Depression Inventory at Baseline.
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Fatigue as Measured Using Fatigue Severity Scale at Baseline.
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during isometric contraction of the knee extensor muscles.
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Maximum torque production during isometric contraction of the knee extensor muscles.
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Maximum torque production during isometric contraction of the knee extensor muscles.
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Maximum torque production during isometric contraction of the knee extensor muscles.
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Full Information
NCT ID
NCT00957671
First Posted
August 10, 2009
Last Updated
May 29, 2018
Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00957671
Brief Title
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Official Title
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
Collaborators
The Moody Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).
Detailed Description
This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Growth hormone deficiency will be replaced for a period of one year. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency, Traumatic Brain Injury
Keywords
TBI, Traumatic Brain injury, Growth hormone deficiency, Anterior pituitary hormone, Recombinant human growth Hormone, Genotropin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Human Growth Hormone
Arm Type
Experimental
Arm Description
recombinant human growth hormone (rhGH) self administered daily for one year
Intervention Type
Drug
Intervention Name(s)
Recombinant human growth hormone
Other Intervention Name(s)
Genotropin, Somatropin, hGH
Intervention Description
200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
Primary Outcome Measure Information:
Title
Maximum Oxygen Uptake at Baseline.
Description
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
baseline
Title
Maximum Oxygen Uptake After One Year of Human Growth Hormone Replacement Therapy.
Description
Maximum Oxygen Uptake was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
one year
Title
Minute Ventilation at Baseline.
Description
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
baseline
Title
Minute Ventilation After One Year of Human Growth Hormone Replacement Therapy.
Description
Minute ventilation was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
one year
Title
Respiratory Exchange Ratio at Baseline.
Description
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
baseline
Title
Respiratory Exchange Ratio After One Year of Human Growth Hormone Replacement Therapy.
Description
Respiratory exchange ratio was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart.
Time Frame
one year
Title
Oxygen Pulse at Baseline.
Description
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time Frame
baseline
Title
Oxygen Pulse After One Year of Human Growth Hormone Replacement Therapy.
Description
Oxygen Pulse was measured during cardiorespiratory testing using a modified Balke protocol with expired gases collected and analyzed by an automated metabolic cart. Oxygen pulse is calculated by dividing VO2 consumed (mL/min) by heart rate (beats/min) yielding mL/beat. This provides an estimate of cardiac stroke volume.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall at Baseline.
Description
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by California Verbal Learning Test-II With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Description
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Total recall is a sum of all word list items correctly recalled immediately on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame
One year
Title
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall at Baseline.
Description
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by California Verbal Learning Test-II With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Description
The California Verbal Learning Test II (CVLT-II) is a comprehensive assessment of verbal learning and memory. Subjects are read a list of 16 words. Delayed recall is a sum of all word list items correctly recalled after a 25 minute delay on learning trials 1 through 5. Data is reported as raw scores. Score range is 0 (lowest) to 80 (highest). A higher score indicates a better outcome.
Time Frame
One year
Title
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall at Baseline
Description
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Total Recall After 1 Year of Human Growth Hormone Replacement Therapy.
Description
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. Total recall is a measure of the subjects memory immediately after viewing the stimulus page. Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame
one year
Title
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall at Baseline
Description
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by Brief Visuospatial Memory Test-R With Delayed Recall After 1 Year of Human Growth Hormone Replacement Therapy
Description
The Brief Visuospatial Memory Test is measure of visual memory. The subject views a stimulus page with 6 shapes on it for 10 seconds. The subjects are then asked to draw as many figures as they remember in the correct locations as possible. The delayed recall is a measure of the subjects memory after a 25 minutes delay. The participants are asked to freely recall and again draw the six figures.Data is reported as raw scores. Scores range from 0 (lowest) to 36 (highest). A higher score indicates a better outcome.
Time Frame
one year
Title
Neuropsychological Function as Measured by Digit Span Total at Baseline
Description
Digit Span; Wechsler Memory Scale III (WMS III).
Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by Digit Span Total After One Year of Human Growth Hormone Replacement Therapy.
Description
Digit Span; Wechsler Memory Scale III (WMS III). Digits Forward is a test of digit span (range = 3 to 9 digits) consisting of seven items (each with 2 trials). Digits Backward is a test of digit span (range = 3 to 9 digits); however the participant must provide the presented sequence in reverse order. The test consists of seven items (each with 2 trials). Total score is calculated by adding the scores from forward and backward. Data is reported as raw scores. Score ranges are 0 (lowest) to 32 (highest). A higher score indicates a better outcome.
Time Frame
one year
Title
Neuropsychological Function as Measured by Processing Speed Index at Baseline
Description
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.
This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.
Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Time Frame
baseline
Title
Neuropsychological Function as Measured by Processing Speed Index After One Year of Human Growth Hormone Replacement Therapy.
Description
Processing Speed Index is a subcategory of the Wechsler Adult Intelligence Scale III (WAIS-III). Processing speed refers to the speed of cognitive processes and response output.
This index is comprised of performances on two separate tests of visuomotor speed of information processing ability. On one test (Coding) participants refer to a key on top of a page to translate non-verbal symbols to an alpha-numeric digit. The participants then fill in boxes with the correct symbol assigned to a particular number. On the other test (Symbol Search) participants are asked to visually scan and mark items that are identical to one of two targets. If neither target is shown in the array the participant must mark out the work "NO". Total correct responses for both task within 120 seconds are recorded.
Ranges are 0 (lowest) to 150 (highest) with 100 being the normal average. A higher score indicates a better outcome.
Time Frame
one year
Title
Neuropsychological Function as Measured by Letter Fluency at Baseline
Description
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time Frame
baseline
Title
Neuropsychological Function as Measured by Letter Fluency After One Year of Human Growth Hormone Replacement Therapy
Description
Letter Fluency is a condition measured as part of the subcategory, Verbal Fluency, in the Delis-Kaplan Executive Function System (D-KEFS). Subjects are asked to name as many words as they can starting with a specified letter for 60 seconds. The words can not be names, places, numbers or grammatical variants of previous answers. Repeated answers are not scored as a correct response. There are 3 trials, with 3 different letters. The total number of correct responses is totaled for all 3 trials and a Letter Fluency Score is given. A higher score is considered better. There is no set range as the score depends on how many correct words the subject relays in the given time period.
Time Frame
one year
Title
Depression as Measured by the Beck Depression Inventory at Baseline.
Description
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Time Frame
baseline
Title
Depression as Measured by Beck Depression Inventory After One Year of Human Growth Hormone Replacement Therapy.
Description
Beck Depression Inventory (BDI-II) is used to measure the severity of depression symptoms. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs are: 0-13: minimal depression; 14-19: mild; depression; 20-28: moderate depression; 29-63: severe depression.
Time Frame
one year
Title
Fatigue as Measured Using Fatigue Severity Scale at Baseline.
Description
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time Frame
baseline
Title
Fatigue Measured Using the Fatigue Severity Scale After One Year of Human Growth Hormone Therapy.
Description
Fatigue Severity Scale (FSS) is a measure of fatigue and how that fatigue interferes with life. It is a 9-item scale, with a range from 9 to 63, with a higher number indicating greater severity.
Time Frame
one year
Title
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Description
Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame
baseline
Title
Muscle Function in Male Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Description
Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame
one year
Title
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline.
Description
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame
baseline
Title
Muscle Function in Male Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Description
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame
one year
Title
Muscle Fatigue as Measured by Biodex Pro 4 at Baseline.
Description
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time Frame
baseline
Title
Muscle Fatigue as Measured by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy.
Description
Muscle fatigue is measured using repetitive isokinetic contractions of the knee extensors at 90 degrees per second. Each subject was asked to produce 40 contractions at full force. Data is presented as % of maximum torque at the 40th contraction in the fatigue protocol.
Time Frame
one year
Title
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Description
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time Frame
baseline
Title
Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame
one year
Title
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Description
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame
baseline
Title
Lean Body Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame
one year
Title
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Description
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time Frame
baseline
Title
Fat Free Mass in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time Frame
one year
Title
Percent Body Fat as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Description
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame
baseline
Title
Percent Body Fat in Male Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame
one year
Title
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 at Baseline.
Description
Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame
baseline
Title
Muscle Function in Female Subjects Measured Using Maximum Isometric Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Description
Maximum torque production during isometric contraction of the knee extensor muscles.
Time Frame
one year
Title
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 at Baseline
Description
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame
baseline
Title
Muscle Function in Female Subjects Measured Using Maximum Isokinetic Leg Extension by Biodex Pro 4 After One Year of Human Growth Hormone Replacement Therapy
Description
Maximum torque production during maximal isokinetic contractions at 90 degrees per second.
Time Frame
one year
Title
Perceptual Fatigability as Measured by a Fatigue Rating Scale at Baseline.
Description
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time Frame
baseline
Title
Perceptual Fatigability as Measured by a Fatigue Rating Scale After One Year of Human Growth Hormone Therapy.
Description
Perceptual fatigue was measured before and directly after performing the muscle fatigue exercise protocol (40 continuous maximal force isokinetic knee extensions at 90 degress per second). Subjects were asked to rate their fatigue on a scale of 0-10 with 0 being no fatigue at all and 10 being extreme fatigue. Data is presented as change in fatigue rating induced by exercise testing.
Time Frame
one year
Title
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Time Frame
baseline
Title
Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Description
Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame
one year
Title
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline
Description
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA.
Time Frame
baseline
Title
Lean Body Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Lean Body mass was calculated from whole body scan taken using a GE Lunar iDEXA
Time Frame
one year
Title
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Description
Fat free mass is calculated from whole body scan measured using a GE Lunar iDEXA.
Time Frame
baseline
Title
Fat Free Mass in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy
Description
Fat free mass is calculated from whole body scan measured on a GE Lunar iDEXA.
Time Frame
one year
Title
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) at Baseline.
Description
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame
baseline
Title
Percent Body Fat in Female Subjects as Measured by Dual Energy X-Ray Absorptiometry (DEXA) After One Year of Human Growth Hormone Replacement Therapy.
Description
Percent body fat is calculated from a whole body scan measured on a GE Lunar iDEXA.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 21 and older.
Documented moderate to severe traumatic brain injury at least one year post injury.
Exclusion Criteria:
The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall J Urban, M.D.
Organizational Affiliation
The University of Texas Medical Branch at Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Transitional Learning Center
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
Facility Name
The University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
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