search
Back to results

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI) (rTMS TBI)

Primary Purpose

TBI Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)
Sham Comparator: Sham Treatment
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TBI Depression focused on measuring TBI Depression, co-morbid psychiatric symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults aged 18 and over
  2. H/o closed head injury
  3. Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI)
  4. Must meet criteria for major depression as assessed by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual IV (DSM-IV) and a score greater than 10 on the Hamilton Depression 17 (HAM-D17) Scale

Exclusion Criteria:

  1. Subjects with skull fracture
  2. Subjects who meet DoD criteria for severe TBI
  3. Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics.
  4. Subjects who are medically unstable
  5. History of active substance abuse x 1 month
  6. Current psychotic illness
  7. Evidence of frontal lesions on brain scan.
  8. Individuals with a significant neurological disorders that could increase risk of seizures such as brain tumor, cerebral aneurysm, any h/o seizures and/or family h/o seizures
  9. Dementia
  10. Mini Mental State Exam score of less than or equal to 24
  11. A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire
  12. Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit
  13. History of treatment with rTMS therapy for any disorder
  14. History of treatment with Vagus Nerve Stimulation (VNS)
  15. History of treatment with Deep Brain Stimulation (DBS)
  16. Cardiac pacemakers, implanted medication pumps, intracardiac lines,
  17. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
  18. Implanted neurostimulators
  19. Known or suspected pregnancy
  20. Investigators, personnel affiliated with this study, and their immediate families.

Sites / Locations

  • Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LFR rTMS

Sham Treatment

Arm Description

Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.

Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength

Outcomes

Primary Outcome Measures

Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, >/= 23 = Very Severe Depression.
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation

Secondary Outcome Measures

Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the "congruous condition" in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, "incongruous condition" the color-words are printed in a different color in (ie: the word "red" is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome.
Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome.
Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome.
Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome.
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome.
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say "yes" after each word that appeared on the recall list (12 targets) and "no" after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21. 0-4 = normal 5-9 = mild 10-14 = moderate >15 = severe
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD). Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome.
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of "5" or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following: Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education. Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment.
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
The FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A higher score reflects greater fatigue severity.
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
MOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
The SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
The STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.

Full Information

First Posted
February 9, 2015
Last Updated
August 3, 2018
Sponsor
Johns Hopkins University
Collaborators
United States Department of Defense
search

1. Study Identification

Unique Protocol Identification Number
NCT02367521
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Acronym
rTMS TBI
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Traumatic brain injury (TBI) is frequently complicated by depression and other problems such as post traumatic stress disorder (PTSD), sleep disturbance, cognitive deficits and behavioral problems. Untreated depression can lead to reduced productivity and poor global outcome. There is no Food and Drug Administration (FDA) approved drug for the treatment of TBI-related depression. The overarching goal of this small study is to determine the effectiveness of low frequency right (LFR) rTMS for the treatment of post-TBI depression and co-occurring psychiatric symptoms. Repetitive transcranial magnetic stimulation (rTMS) is a brain stimulation technique. It involves generating a brief magnetic field in a coil that is placed on the scalp. The magnetic field passes through the skull and induces a weak electrical current in the brain that briefly activates neural circuits at the stimulation site. Adults aged 18 and older, with a history of head injury of mild or moderate severity , who are currently experiencing symptoms of clinical depression may join the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI Depression
Keywords
TBI Depression, co-morbid psychiatric symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LFR rTMS
Arm Type
Experimental
Arm Description
Investigators propose to deliver 1200 pulses daily at 110% Motor threshold for 4 weeks using four trains of 300 pulses daily separated by an intertrain interval of 60 seconds.
Arm Title
Sham Treatment
Arm Type
Placebo Comparator
Arm Description
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Intervention Type
Combination Product
Intervention Name(s)
Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)
Other Intervention Name(s)
low frequency right rTMS
Intervention Description
LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group. Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength.
Intervention Type
Device
Intervention Name(s)
Sham Comparator: Sham Treatment
Other Intervention Name(s)
Placebo
Intervention Description
Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
Primary Outcome Measure Information:
Title
Average Depression Score Using the Hamilton Depression (HAM-D) 17 Scale
Description
The HAM-D was used to determine the effectiveness of LFR rTMS for the treatment of post-TBI depression. The scale ranges from 0-54, with 0-7 = Normal; 8-13= Mild Depression; 14-18= Moderate Depression, 19-22= Severe Depression, >/= 23 = Very Severe Depression.
Time Frame
Mean at baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks
Title
Mean Clinical Global Improvement- Severity/Improvement Scale Score (CGI-I/CGI-S)
Description
The CGI scale is broken down into the CGI-S and CGI-I components. CGI-S is the baseline severity of mental illness. 1= normal, not at all ill; 2= borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S is only performed at baseline. The CGI-I component (which is any measure after intervention) is as follows: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Mean Suicidal Ideation as Assessed by the Beck Suicidal Ideation Scale (BSSI)
Description
The BSSI scale is used to assess the degree of suicidal ideation. The scale ranges from 0-38, with 0= no suicidality, and 38 = highest severity of suicidal ideation
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Secondary Outcome Measure Information:
Title
Ability to Inhibit Cognitive Interference as Assessed by the Stroop Color Word Test (SCWT)
Description
The SCWT is used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute. Participants are required to read three different tables as fast as possible. Two of the tables represent the "congruous condition" in which participants are required to read names of colors printed in black ink and name different color patches. In the third table, "incongruous condition" the color-words are printed in a different color in (ie: the word "red" is printed in green ink). Within this third table, participants are required to name the color of the ink instead of reading the word. The score is based on the number of items completed, which ranges from 0 to 100, with a higher score reflecting a better outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Cognitive Reasoning as Assessed by the Number of Completed Categories on the Wisconsin Card Scoring Test (WCST)
Description
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of completed categories, ranging from 0-6. A higher score reflects a better outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Cognitive Reasoning as Assessed by the Number of Errors Made on the Wisconsin Card Sorting Test (WCST)
Description
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of errors, ranging from 0-128. A higher score reflects a poorer outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Cognitive Reasoning as Assessed by the Number of Correct Trials on the Wisconsin Card Scoring Test (WCST)
Description
The participant points to choice on the screen and the tester manipulates the mouse to make the response. The participant tells the tester if he or she wants to change the response and the tester clicks on the screen. The score is the number of correct trials, ranging from 0-128. A higher score reflects a better outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Evaluation of Brain Injury as Assessed by the Trailmaking Test B Score
Description
The Trailmaking B score is the number of seconds spent connecting numbered circles (1-13) to circles containing letters of the alphabet (A-L) in alternating sequential order. A maximum of 300 seconds is allowed. Score ranges from 0-300. Higher score reflects poorer outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Immediate Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Description
The Hopkins Verbal Learning Test (HVLT) consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. The number of correctly-recalled words in each trial is recorded (maximum of 12). The score is a sum of all the correctly-recalled words from each trial, for a maximum score of 36.
Time Frame
Mean at baseline and 16 weeks
Title
Delayed Recall as Assessed by Hopkins Verbal Learning Test (HVLT)
Description
The HVLT consists of a 12-item word list, composed of four words from each of the three semantic categories. The subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The word list is then read to the subject at the approximate rate of one word every 2 seconds. This is done for three trials. After the third learning trial, the patient is read 24 words and is asked to say "yes" after each word that appeared on the recall list (12 targets) and "no" after each word that did not (12 distractors). Half of the distractors are drawn from the same semantic categories as the targets (related distractors) and half are drawn from other categories (unrelated distractors). The number of correctly-recalled words in each trial is recorded (maximum of 12 per trial). The score is the sum of all the correctly-recalled words from each trial, for a maximum of 36. T-scores are reported (average T-score of 50 (ranges 40-60)
Time Frame
Mean at baseline and 16 weeks
Title
Delayed Recall as Assessed by Brief Visual Memory Test (BVMT)
Description
BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location after a 25-minute delay filled with other distractor tasks. Scoring of the delayed recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial for a total score range of 0-36, with higher scores indicating a better outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Immediate Recall as Assessed by Brief Visual Memory Test (BVMT)
Description
BVMT is used to evaluate visuospatial memory abilities in neuropsychological populations. A visual display of six simple figures arranged in a 2 × 3 matrix on an 8 × 11 booklet is shown to participants for three consecutive 10-second trials. After each trial, participants are to draw as many designs as accurately as they can and in the correct location. Scoring of the immediate recall is based on the accuracy of the drawings and the location of the figures. For each figure, one point is awarded to each satisfactory domain resulting in a maximum of 12-points per trial, for a total score ranging from 0-36, with a higher score reflecting a better outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Evaluation of Brain Injury as Assessed by the Trailmaking Test A Score
Description
Trailmaking A is a psychological test with a score that is the number of seconds spent in connecting 25 numbered circles in sequential order. Score ranges from 0-150. Higher score reflects poorer outcome.
Time Frame
Mean at baseline and 16 weeks
Title
Mean Generalized Anxiety Disorder (GAD) - 7 Questionnaire
Description
The GAD-7 questionnaire is used as a screening tool and severity measure for generalized anxiety disorder. The scale ranges from 0 - 21. 0-4 = normal 5-9 = mild 10-14 = moderate >15 = severe
Time Frame
Baseline, 4, 8, 12, and 16 weeks
Title
Mean Trauma Severity as Assessed by the Davidson Trauma Scale (DTS)
Description
The DTS is a 17-item self-reported measure that assesses the 17 Diagnostic and Statistical Manual IV (DSM-IV) symptoms of post-traumatic stress disorder (PTSD). Items are rated on 5-point frequency (0 = "not at all" to 4 = "every day") and severity scales (0 = "not at all distressing" to 4 = "extremely distressing"). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). The severity score will be used to assess this outcome.
Time Frame
Baseline, 4, 8, 12, and 16 weeks
Title
Mean Level of Fatigue as Assessed by Patient Sleep Quality Index (PSQI)
Description
The PSQI score scale ranges from 0-21. 0 = very good sleep quality 21 = very bad sleep quality A total score of "5" or greater is indicative of poor sleep quality (reflecting a higher level of fatigue)
Time Frame
Baseline, 4, 8, 12, and 16 weeks
Title
Mean Level of Fatigue as Assessed by the Epworth Sleepiness Scale (ESS)
Description
The ESS is used to determine the level of daytime sleepiness. It is a questionnaire composed of 8 questions. The participant answers each question on a scale of 0 to 3 (0=no sleepiness, 1= mild sleepiness, 2= moderate sleepiness, 3= severe sleepiness). The total score is the sum of all responses for a maximum score of 24. A higher score reflects increased sleepiness.
Time Frame
Baseline, 4, 8, 12, and 16 weeks
Title
Mean Cognitive Function as Assessed by the Montreal Cognitive Assessment (MOCA)
Description
MOCA is designed to assess cognitive impairment and Alzheimer's Disease. It is composed of the following: Visuospatial and Executive Functioning: 5 points Animal Naming: 3 points Attention: 6 points Language: 3 points Abstraction: 2 points Delayed Recall (Short-term Memory): 5 points Orientation: 6 points Education Level: 1 point is added to the test-taker's score if he or she has 12 years or less of formal education. Score ranges 0-31, with ≥ 26 being normal cognitive function. The lower the score, the greater the level of cognitive impairment.
Time Frame
Mean at baseline and 16 weeks
Title
Presence of Neuropsychiatric Symptoms as Assessed by Neurobehavioral Rating Scale (NBRS)
Description
The NBRS is a 28-item interview which includes a test of orientation and memory for recent events, questions regarding emotional state, post-concussional symptoms, focused attention, and concentration (performing serial sevens), explanation of proverbs, tasks of planning and mental flexibility, and delayed recall of three objects presented at the beginning of a session. Observations are also made regarding the patient's fatigability, visible signs of anxiety, disinhibition, agitation, hostility, difficulties in expressive and receptive communication, and disturbance of mood. The balance of the items are rated according to the patient's performance on brief tasks and quality of answers to interview questions. Each of the 28 items are scored on a scale of 0 (not severe) to 6 (extremely severe), for a maximum score of 168. A higher score reflects increased severity of neuropsychiatric symptoms.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Presence of Post-concussive Symptoms as Assessed by the Rivermead Post-Concussion Questionnaire (RPQ)
Description
Participants are asked to rate the severity of 16 different symptoms over the past 24 hours, on a severity scale from 0 to 4 (0 = not experienced, 1 = no more of a problem, 2 = mild problem, 3 = moderate problem, 4 = severe problem). The 16 symptoms include: headaches, dizziness, nausea and/or vomiting, hyperacusis, sleep disturbance, fatigue, being irritable, feeling depressed, feeling frustrated, forgetfulness, poor concentration, taking longer to think, blurred vision, light sensitivity, double vision, restlessness. Score ranges from 0 to 64, with a higher score reflecting increased severity of post-concussive symptoms.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Fatigue Severity as Assessed by the Fatigue Severity Scale (FSS)
Description
The FSS is a 9-item questionnaire which measures the severity of fatigue and how it interferes with certain activities. The items are scored on a 7-point scale with 1=strongly disagree and 7=strongly agree. The score ranges from 9 to a maximum of 63. A higher score reflects greater fatigue severity.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Aggressive Behavior as Assessed by the Modified Overt Aggression Scale (MOAS)
Description
MOAS measures four types of aggressive behavior as witnessed in the past week. Each section consists of five items, with the first section regarding verbal aggression, the second section focusing on aggression against property, the third section measuring autoaggression, and the fourth section concerning physical aggression. Participants are asked to check each item that is true over the last week. Items are allocated 0, 1, 2, 3 or 4 point(s), and then all points for each selected item are summed. The maximum total for each section is 10 if all items are selected. Total score ranges from 0-40 with a higher score indicating more aggressive behavior.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Overall Satisfaction With Life as Assessed by the Satisfaction With Life (SWL) Questionnaire
Description
The SWL is a 7-point Likert-style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks
Title
Presence of Social Connections as Assessed by the Social Ties Checklist (STC)
Description
The STC reflects the level of social contact. The score ranges from 0-10, with 0= excellent contact, 10=no contact. A higher score reflects poorer social contact.
Time Frame
Mean at baseline, 4, 8, 12, and 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged 18 and over H/o closed head injury Must meet Department of Defense (DoD) criteria for mild or moderate Traumatic Brain Injury (TBI) Must meet criteria for major depression as assessed by the Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual IV (DSM-IV) and a score greater than 10 on the Hamilton Depression 17 (HAM-D17) Scale Exclusion Criteria: Subjects with skull fracture Subjects who meet DoD criteria for severe TBI Subjects who are on psychotropics or mood stabilizing medications (e.g. antidepressants, antipsychotics, anxiolytics, sedative/hypnotics. Subjects who are medically unstable History of active substance abuse x 1 month Current psychotic illness Evidence of frontal lesions on brain scan. Individuals with a significant neurological disorders that could increase risk of seizures such as brain tumor, cerebral aneurysm, any h/o seizures and/or family h/o seizures Dementia Mini Mental State Exam score of less than or equal to 24 A positive and unmitigated response to any question on the Transcranial Magnetic Stimulation Safety Screen questionnaire Electroconvulsive therapy (ECT) treatment within 6 months prior to the screening visit History of treatment with rTMS therapy for any disorder History of treatment with Vagus Nerve Stimulation (VNS) History of treatment with Deep Brain Stimulation (DBS) Cardiac pacemakers, implanted medication pumps, intracardiac lines, Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. Implanted neurostimulators Known or suspected pregnancy Investigators, personnel affiliated with this study, and their immediate families.
Facility Information:
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Depression & Other Neuropsychiatric Symptoms After Traumatic Brain Injury (TBI)

We'll reach out to this number within 24 hrs