Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot 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Withdrawn before enrolling · Not applicable · Has a placebo group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 determine the feasibility of combining PoNS therapy with standard vestibular and balance therapy with the proposed double-blind design; evaluate preliminary indications of efficacy. This study is also evaluating recruitment rate, completion rate, device usability, and outcome measures feasibility. * Goal for recruitment: 100% of 30 subjects meeting all inclusion criteria can be recruited over the 36 week pilot recruitment phase. * Completion and compliance: 90% of subjects will complete the study, 90% of sessions within each subject will be completed, and for completing subjects, 100% of measures will be completed. * Useability: all therapists and subjects must rate useability as good or better. * Success of blind: subject accuracy at guessing group membership must be at or near 50%.

Key facts

Study ID

NCT02109198

Run by

U.S. Army Medical Research and Development Command

People needed

0

Starts

2015-06-01

Expected to finish

2016-08-01

Last updated by the study team

2015-06-02

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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