search
Back to results

Imaging Lymphatic/Cerebrospinal Fluid (CSF) Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery

Primary Purpose

Trauma, Brain, Neuroinflammation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Lymphatic Drainage (MLD)
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma, Brain focused on measuring traumatic brain injury, lymphatic drainage, cerebrospinal fluid

Eligibility Criteria

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

Inclusion Criteria:

  • Female participants must complete the Female Enrollment Form. Those subjects of childbearing potential must have a negative urine pregnancy within 36 hours of study drug administration and also agree to use one of the medically accepted methods of contraception listed on the form for a period of one month following the study. Female subjects of non-childbearing potential, defined as physiologically incapable of becoming pregnant, must meet the criteria listed on the Female Enrollment form, but are not restricted to the use of contraception following study participation.
  • Participants must be able to sit upright for periods of 30 minutes.
  • Participants should have a body mass index between 19 and 30 kg/m2
  • Initial post-resuscitation Glasgow Coma Scale score following blunt head trauma of 3 to 12 or coma (not due to sedation) greater than 6 hours. Emergence from Post-traumatic Amnesia as documented by serial administration of the Orientation-Log or Galveston Orientation and Amnesia Test
  • Have an anticipated hospital length of stay of 5 days or more following screening and consent.
  • Able to provide consent.

Exclusion Criteria:

  • Women who are pregnant or breast-feeding
  • Persons who are known to be allergic to iodine
  • Persons who have extensive soft tissue damage to the neck region, including carotid artery dissection, spinal cord injury, or other conditions, that makes lymphatic drainage techniques undesirable.
  • Women who are of child bearing potential who do not agree to use medically acceptable contraceptives for one month following the study.
  • Subjects who are participating in another interventional trial.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manual Lymphatic Drainage (MLD)

Arm Description

Outcomes

Primary Outcome Measures

change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
2 NIRF-LI sessions will be conducted separated by 3 days.
change in cognitive test results as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global health( GH) scale
Nine of the 10 PROMIS GH items are scored on a Likert scale from 1 to 5, with 5 representing the best health. Pain which is the 10th question is scored from 0(no pain) to 10(worst imaginable pain).
change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9)
This scale consists of a set of 9 questions each scored form 0(not at all) to 3 (nearly every day), a higher score indicating a worse outcome. Total score ranges form 0-27.
change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association
This is used to asses phonemic fluency. Participant is asked to name words that begin with a particular letter in one minute and examiner will write down the words said by the participant. This will be reported y the number of words participants say in one minute
change in cognitive test results as assessed by the Trail Making Test(TMT)
Scores are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
change in cognitive test results as assessed by the learning trial
This will be assessed by the number of words participants can remember
change in cognitive test results as assessed by the delayed recall trial instructions
This will be assessed by the number of words participants can remember after 20-25 minutes delay
change in cognitive test results as assessed by the Semantic Category learning trial
There are 12 words that participants will categories as Four-legged Animals, precious stones and human dwellings for a total score from 0-12 a higher number indicates a better outcome
Change in processing speed, as assessed by the Wechsler Adult Intelligence Scale -IV
Two subtests from the Wechsler Adult Intelligence Scale - IV are used (Coding and Symbol Search). Age-adjusted standard scores are calculated for each of subtest. The 2 subtest scores are then combined to create the Processing Speed Index. Processing Speed Index will be reported as a percentile (0% to 100%), with a higher percentile indicating a better outcome

Secondary Outcome Measures

Change in NIRF-LI detected lymphatic drainage
response of NIRF-LI detected lymphatic drainage in response to manual lymphatic drainage by imaging drainage before and after manual lymphatic drainage

Full Information

First Posted
November 9, 2021
Last Updated
November 9, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
HeadStrong Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT05129514
Brief Title
Imaging Lymphatic/Cerebrospinal Fluid (CSF) Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery
Official Title
Imaging Lymphatic/CSF Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
HeadStrong Foundation

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to determine whether a course of daily manual lymphatic drainage over the course of 5 days can improve lymphatic drainage function and cognitive outcomes and to determine whether single sessions of manual lymphatic drainage improves lymphatic drainage in moderate to severe traumatic brain injury (TBI) patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Brain, Neuroinflammation
Keywords
traumatic brain injury, lymphatic drainage, cerebrospinal fluid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual Lymphatic Drainage (MLD)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Manual Lymphatic Drainage (MLD)
Intervention Description
The participant will be placed in a supine position and manual lymphatic drainage will be performed for 50 minutes. During the three intervening days, daily 50 minute sessions of manual lymphatic drainage will be provided.
Primary Outcome Measure Information:
Title
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
Description
2 NIRF-LI sessions will be conducted separated by 3 days.
Time Frame
day 1, day 5
Title
change in cognitive test results as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global health( GH) scale
Description
Nine of the 10 PROMIS GH items are scored on a Likert scale from 1 to 5, with 5 representing the best health. Pain which is the 10th question is scored from 0(no pain) to 10(worst imaginable pain).
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Description
This scale consists of a set of 9 questions each scored form 0(not at all) to 3 (nearly every day), a higher score indicating a worse outcome. Total score ranges form 0-27.
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association
Description
This is used to asses phonemic fluency. Participant is asked to name words that begin with a particular letter in one minute and examiner will write down the words said by the participant. This will be reported y the number of words participants say in one minute
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the Trail Making Test(TMT)
Description
Scores are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the learning trial
Description
This will be assessed by the number of words participants can remember
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the delayed recall trial instructions
Description
This will be assessed by the number of words participants can remember after 20-25 minutes delay
Time Frame
day1,day2,day3,day4,day5
Title
change in cognitive test results as assessed by the Semantic Category learning trial
Description
There are 12 words that participants will categories as Four-legged Animals, precious stones and human dwellings for a total score from 0-12 a higher number indicates a better outcome
Time Frame
day1,day2,day3,day4,day5
Title
Change in processing speed, as assessed by the Wechsler Adult Intelligence Scale -IV
Description
Two subtests from the Wechsler Adult Intelligence Scale - IV are used (Coding and Symbol Search). Age-adjusted standard scores are calculated for each of subtest. The 2 subtest scores are then combined to create the Processing Speed Index. Processing Speed Index will be reported as a percentile (0% to 100%), with a higher percentile indicating a better outcome
Time Frame
day1,day2,day3,day4,day5
Secondary Outcome Measure Information:
Title
Change in NIRF-LI detected lymphatic drainage
Description
response of NIRF-LI detected lymphatic drainage in response to manual lymphatic drainage by imaging drainage before and after manual lymphatic drainage
Time Frame
day1,day5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female participants must complete the Female Enrollment Form. Those subjects of childbearing potential must have a negative urine pregnancy within 36 hours of study drug administration and also agree to use one of the medically accepted methods of contraception listed on the form for a period of one month following the study. Female subjects of non-childbearing potential, defined as physiologically incapable of becoming pregnant, must meet the criteria listed on the Female Enrollment form, but are not restricted to the use of contraception following study participation. Participants must be able to sit upright for periods of 30 minutes. Participants should have a body mass index between 19 and 30 kg/m2 Initial post-resuscitation Glasgow Coma Scale score following blunt head trauma of 3 to 12 or coma (not due to sedation) greater than 6 hours. Emergence from Post-traumatic Amnesia as documented by serial administration of the Orientation-Log or Galveston Orientation and Amnesia Test Have an anticipated hospital length of stay of 5 days or more following screening and consent. Able to provide consent. Exclusion Criteria: Women who are pregnant or breast-feeding Persons who are known to be allergic to iodine Persons who have extensive soft tissue damage to the neck region, including carotid artery dissection, spinal cord injury, or other conditions, that makes lymphatic drainage techniques undesirable. Women who are of child bearing potential who do not agree to use medically acceptable contraceptives for one month following the study. Subjects who are participating in another interventional trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Sevick, PhD
Phone
(713) 500-3560
Email
Eva.Sevick@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Rasmussen
Phone
(713) 500-3393
Email
John.Rasmussen@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Sevick, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Sevick, PhD
Phone
713-500-3560
Email
Eva.Sevick@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
John Rasmussen
Phone
(713) 500-3393
Email
John.Rasmussen@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Imaging Lymphatic/Cerebrospinal Fluid (CSF) Drainage From the Head and Neck in Persons With Traumatic Brain Injury: Demonstration of Feasibility and Evaluation of Manual Therapy to Improve Drainage and Facilitate Cognitive Recovery

We'll reach out to this number within 24 hrs