Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot 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Status: Withdrawn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

NCT02109198

CN-NINM pilot

Details and patient eligibility

About

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%.

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

0 participants in 2 patient groups, including a placebo group

Active CN-NINM PoNS

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

Placebo 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