Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)

Not Applicable

Withdrawn

• Conditions: Mild Traumatic Brain Injury
• Interventions: Device: Sham CN-NINM PoNS; Device: Active CN-NINM PoNS

• Registration Number: NCT02125591
• Lead Sponsor: U.S. Army Medical Research and Development Command

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-25
• Study First Posted: 2014-04-29
• Status Verified: 2014-10
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-22
• Study Start: 2015-08
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Veteran or Servicemember
2. 18 to 50 years old
3. Sustained one or more mild traumatic brain injury (mTBI)s
4. 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))
5. Available for the duration of the study

Exclusion Criteria

1. History of traumatic brain injury (TBI) of any severity other than mild TBI

2. Presence of active substance abuse condition

3. Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)

4. Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)

5. Orthostatic hypotension as defined by:

   1. A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
   2. A diastolic blood pressure decrease of at least 10 mmHg, or
   3. A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion

6. An implanted medical device

7. Pregnancy

8. Oral infection

9. Known transmissible disease (HIV, hepatitis, influenza, TB)

10. Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham PoNS CN-NINM	Sham CN-NINM PoNS	Sham CN-NINM PoNS - Sham cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy
Active PoNS CN-NINM	Active CN-NINM PoNS	Active CN-NINM PoNS - Active cranial-nerve non-invasive neuromodulation (CN-NINM) using the Portable Neuromodulation Stimulator (PoNS) and balance/gait rehabilitation with physical therapy

Primary Outcome Measures

Name	Time	Method
Change in Sensory Organization Test (SOT)	12 weeks	Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in neuroimaging using functional magnetic resonance imaging (fMRI)	12 weeks	For fMRI, a repeated single-shot echo-planar imaging will be acquired
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)	12 weeks	DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
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

Trial Locations

Locations (2)

McGuire Veterans Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States