Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)
Withdrawn before enrolling · Not applicable · Has a placebo group
Conditions studied: Mild Traumatic Brain Injury
In brief
The purpose of this study is to evaluate improvement in balance after receiving physical therapy when augmented by CN-NINM than when augmented by a placebo (sham CN-NINM).
Key facts
- Study ID
- NCT02125591
- Run by
- U.S. Army Medical Research and Development Command
- People needed
- 0
- Starts
- 2015-08-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2015-05-22
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Veteran or Servicemember
- 18 to 50 years old
- Sustained one or more mild traumatic brain injury (mTBI)s
- Demonstration of balance deficits on the Sensory Organization Test (a composite score of 75 or less (1/3 sample) and 72 or less (2/3 sample))
- Available for the duration of the study
You may not qualify if…
- History of traumatic brain injury (TBI) of any severity other than mild TBI
- Presence of active substance abuse condition
- Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
- Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
- Orthostatic hypotension as defined by:
- A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
- A diastolic blood pressure decrease of at least 10 mmHg, or
- A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion
- An implanted medical device
- Pregnancy
- Oral infection
- Known transmissible disease (HIV, hepatitis, influenza, TB)
- Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
Where it is running
- McGuire Veterans Affairs Medical Center — Richmond, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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