Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial

U.S. Army Medical Research and Development Command2 sites in 1 countryAugust 2015

ConditionsMild Traumatic Brain Injury

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Mild Traumatic Brain Injury
Sponsor: U.S. Army Medical Research and Development Command
Locations: 2
Primary Endpoint: Change in Sensory Organization Test (SOT)
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

December 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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
•Oral infection

Outcomes

Primary Outcomes

Change in Sensory Organization Test (SOT)

Time Frame: 12 weeks

Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.

Secondary Outcomes

Change in neuroimaging using functional magnetic resonance imaging (fMRI)(12 weeks)
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)(12 weeks)
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)(12 weeks)
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)(12 weeks)
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)(12 weeks)
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)(12 weeks)
Change in quality of life measured using Short Form 36 (SF-36)(12 weeks)