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

United States Army Medical Research and Development Command (USAMRDC)

Status: Withdrawn

Conditions: Mild Traumatic Brain Injury

Treatments: Device: Active CN-NINM PoNS; Device: Sham CN-NINM PoNS

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02125591

CN-NINM full

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Active PoNS CN-NINM

Experimental group

Description:

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

Treatment:

Device: Active CN-NINM PoNS

Sham PoNS CN-NINM

Sham Comparator group

Description:

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

Treatment:

Device: Sham CN-NINM PoNS