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
NCT ID: NCT05129514
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2021-11-15
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Manual Lymphatic Drainage (MLD)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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HeadStrong Foundation
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Eva Sevick
Professor
Principal Investigators
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Eva Sevick, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Eva Sevick, PhD
Role: primary
John Rasmussen
Role: backup
Other Identifiers
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HSC-MS-21-0080
Identifier Type: -
Identifier Source: org_study_id