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

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

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.

Study Overview

• Status: Terminated
• Conditions: Neuroinflammation; Trauma, Brain
• Intervention / Treatment: Other: Manual Lymphatic Drainage (MLD)

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual Lymphatic Drainage (MLD)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: HeadStrong Foundation
• Investigators: Principal Investigator: Eva Sevick, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: traumatic brain injury; cerebrospinal fluid; lymphatic drainage
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Inflammation; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Pathological Conditions, Signs and Symptoms; Brain Injuries, Traumatic; Neuroinflammatory Diseases; Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Drainage; Manual Lymphatic Drainage
• Other Study ID Numbers: HSC-MS-21-0080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No