Trauma, BrainNCT05129514
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
A study testing Manual Lymphatic Drainage (MLD) in people with Trauma, Brain and Neuroinflammation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Brain, Neuroinflammation
- What is being tested?
- Manual Lymphatic Drainage (MLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
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.
- Conditions
- Trauma, Brain, Neuroinflammation
- Being tested
- Manual Lymphatic Drainage (MLD)
- Keywords
- traumatic brain injury, lymphatic drainage, cerebrospinal fluid
- Medical subject headings
- Brain Injuries, Traumatic, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic Drainage (MLD)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage (MLD) | Experimental | Not described Receives: Other: Manual Lymphatic Drainage (MLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
2 NIRF-LI sessions will be conducted separated by 3 days.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: day1,day2,day3,day4,day5
Secondary outcomes (1)
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
Measured: day1,day5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start18 May 2022
- Primary completion22 Jul 2022
- Study completion31 Dec 2023
Why it stopped: Low recruitment and end of funding for study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, BrainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- HeadStrong Foundation
- Responsible party
- Principal investigator, Eva Sevick, The University of Texas Health Science Center, Houston
- Investigators
- Eva Sevick, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129514
- Sponsor's protocol ID
- HSC-MS-21-0080
- Status last verified
- May 2023
- First submitted
- 9 Nov 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05129514
- Acronym / sponsor ID
- HSC-MS-21-0080
- Conditions
- Trauma, Brain, Neuroinflammation
- Keywords
- traumatic brain injury, lymphatic drainage, cerebrospinal fluid
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment and end of funding for study.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- HeadStrong Foundation
- Study start
- 18 May 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage (MLD) | Experimental | Other: Manual Lymphatic Drainage (MLD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Manual Lymphatic Drainage (MLD) |
Primary outcome
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage
Time frame: day 1, day 5
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
Time frame: day1,day2,day3,day4,day5
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)
Time frame: day1,day2,day3,day4,day5
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
Time frame: day1,day2,day3,day4,day5
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)
Time frame: day1,day2,day3,day4,day5
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
Time frame: day1,day2,day3,day4,day5
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
Time frame: day1,day2,day3,day4,day5
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
Time frame: day1,day2,day3,day4,day5
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
Time frame: day1,day2,day3,day4,day5
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
1 secondary outcome
Change in NIRF-LI detected lymphatic drainage
Time frame: day1,day5
Results and safety
The study was stopped early (reason given: Low recruitment and end of funding for study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Sevick, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage (MLD) in people with Trauma, Brain and Neuroinflammation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment and end of funding for study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) assessment of lymphatic drainage (time frame: day 1, day 5). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.