Imaging Lymphatic/Cerebrospinal Fluid (CSF) Drainage From the Head and Neck in Persons With Traum… (NCT05129514) | Clinical Trial Compass
TerminatedNot Applicable
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
Stopped: Low recruitment and end of funding for study.
United States2 participantsStarted 2022-05-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
Timeframe: day 1, day 5
2
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
3
change in cognitive test results as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Timeframe: day1,day2,day3,day4,day5
4
change in cognitive test results as assessed by the Multilingual Aphasia Examination III-Controlled Oral Word Association
Timeframe: day1,day2,day3,day4,day5
5
change in cognitive test results as assessed by the Trail Making Test(TMT)
Timeframe: day1,day2,day3,day4,day5
6
change in cognitive test results as assessed by the learning trial
Timeframe: day1,day2,day3,day4,day5
7
change in cognitive test results as assessed by the delayed recall trial instructions
Trial details
NCT IDNCT05129514
SponsorThe University of Texas Health Science Center, Houston