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

Trauma, Brain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05129514
• Other study ID #: HSC-MS-21-0080
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Eva Sevick, PhD
• Phone: (713) 500-3560
• Email: Eva.Sevick[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Neuroinflammation
• Trauma, Brain

Intervention

Other:
• Manual Lymphatic Drainage (MLD)
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	HeadStrong Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage	2 NIRF-LI sessions will be conducted separated by 3 days.	day 1, day 5
Primary	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).	day1,day2,day3,day4,day5
Primary	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.	day1,day2,day3,day4,day5
Primary	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	day1,day2,day3,day4,day5
Primary	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.	day1,day2,day3,day4,day5
Primary	change in cognitive test results as assessed by the learning trial	This will be assessed by the number of words participants can remember	day1,day2,day3,day4,day5
Primary	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	day1,day2,day3,day4,day5
Primary	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	day1,day2,day3,day4,day5
Primary	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	day1,day2,day3,day4,day5
Secondary	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	day1,day5