Clinical trial NCT02125591: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)
Official title: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial
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Overall status: WITHDRAWN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: 2014-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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: Change in Sensory Organization Test (SOT)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)
timeFrame: 12 weeks
measure: Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)
timeFrame: 12 weeks
measure: Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)
timeFrame: 12 weeks
measure: Change in quality of life measured using Short Form 36 (SF-36)
timeFrame: 12 weeks
measure: Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)
timeFrame: 12 weeks
measure: Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)
timeFrame: 12 weeks
measure: Change in neuroimaging using functional magnetic resonance imaging (fMRI)
timeFrame: 12 weeks
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: