Clinical trial NCT05129514: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Trauma, Brain
Neuroinflammation
Keywords: traumatic brain injury
lymphatic drainage
cerebrospinal fluid
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: HeadStrong Foundation
First posted: 2021-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
timeFrame: day 1, day 5
measure: change in cognitive test results as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS)-Global health( GH) scale
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the Trail Making Test(TMT)
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the learning trial
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the delayed recall trial instructions
timeFrame: day1,day2,day3,day4,day5
measure: change in cognitive test results as assessed by the Semantic Category learning trial
timeFrame: day1,day2,day3,day4,day5
measure: Change in processing speed, as assessed by the Wechsler Adult Intelligence Scale -IV
timeFrame: day1,day2,day3,day4,day5
Secondary outcomes:
measure: Change in NIRF-LI detected lymphatic drainage
timeFrame: day1,day5
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Eva Sevick, PhD
role: PRINCIPAL_INVESTIGATOR
References: