Clinical trial NCT02109198: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)
Official title: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Mild Traumatic Brain Injury
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: Virginia Commonwealth University
name: US Department of Veterans Affairs
name: The Defense and Veterans Brain Injury Center
First posted: 2014-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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%.


Eligibility criteria: 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).

Primary outcomes:
measure: Recruitment rate
timeFrame: 36 weeks
measure: Completion and compliance rates
timeFrame: Up to 12 weeks
measure: Usability rating
timeFrame: 12 weeks
measure: Success of blinding
timeFrame: 12 weeks
measure: Change in Sensory Organization Test (SOT)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: McGuire Veterans Affairs Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VA Department of Physical Medicine and Rehabilitation
name: David X Cifu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University (VCU)
name: William C Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: