CompletedNot Applicable

The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury

United States29 participantsStarted 2017-09-18

Plain-language summary

Test the hypothesis that a certain set of osteopathic manipulation procedures preformed on patients with mild to moderate traumatic brain injury will result in accelerated rates of recovery assessed using vestibular function tests, quality of life questionnaires and measurements of the levels of anti-inflammatory metabolite and protein biomarkers in the blood and urine.

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: * Diagnosis of mild to moderate traumatic brain injury * Chief complaint of headache and/or dizziness * 18 years or older * Medically stable/free from acute infection or fever * Not a danger to self or others * Not actively engaged in substance abuse * Minimum Ranchos Los Amigos Level of 4 (http://www.traumaticbraininjury.com/symptoms-of-tbi/). Exclusion Criteria: * Minors below age of 18 * Any acute fracture or bleeding * Head, neck or back wounds that would prevent OMT treatment

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

Change from baseline Neurocom Balance Manager assessment in 12 weeks after OMT

Timeframe: 12 weeks

Change of baseline Headache Impact Test (HIT-6) scores after 12 weeks of OMT

Timeframe: 12 weeks

Trial details

NCT IDNCT03163901

SponsorMichigan State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-29

View on ClinicalTrials.gov More Vestibular Disorder trials