Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 7/11/2015 |
| Start Date: | June 2015 |
| End Date: | August 2016 |
| Contact: | Tiffany Lewis, MD |
| Email: | Tiffany.Lewis2@va.gov |
| Phone: | 804-675-5000 |
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
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%.
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%.
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).
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