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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02125591
Recruitment Status : Withdrawn
First Posted : April 29, 2014
Last Update Posted : May 22, 2015
Sponsor:
Collaborators:
Virginia Commonwealth University
US Department of Veterans Affairs
The Defense and Veterans Brain Injury Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Tracking Information
First Submitted Date  ICMJE April 7, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date May 22, 2015
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
Change in Sensory Organization Test (SOT) [ Time Frame: 12 weeks ]
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2014)
  • Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 12 weeks ]
  • Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI) [ Time Frame: 12 weeks ]
  • Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ) [ Time Frame: 12 weeks ]
  • Change in quality of life measured using Short Form 36 (SF-36) [ Time Frame: 12 weeks ]
  • Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C) [ Time Frame: 12 weeks ]
  • Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI) [ Time Frame: 12 weeks ]
    DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
  • Change in neuroimaging using functional magnetic resonance imaging (fMRI) [ Time Frame: 12 weeks ]
    For fMRI, a repeated single-shot echo-planar imaging will be acquired
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)
Official Title  ICMJE Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Mild Traumatic Brain Injury
Intervention  ICMJE
  • Device: Active CN-NINM PoNS
    Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
    Other Names:
    • Active cranial-nerve non-invasive neuromodulation (CN-NINM)
    • Portable Neuromodulation Stimulator (PoNS)
  • Device: Sham CN-NINM PoNS
    Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
Study Arms  ICMJE
  • Experimental: Active PoNS CN-NINM
    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
    Intervention: Device: Active CN-NINM PoNS
  • Sham Comparator: Sham PoNS CN-NINM
    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
    Intervention: Device: Sham CN-NINM PoNS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 25, 2014)
56
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02125591
Other Study ID Numbers  ICMJE CN-NINM full
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party U.S. Army Medical Research and Development Command
Study Sponsor  ICMJE U.S. Army Medical Research and Development Command
Collaborators  ICMJE
  • Virginia Commonwealth University
  • US Department of Veterans Affairs
  • The Defense and Veterans Brain Injury Center
Investigators  ICMJE
Principal Investigator: David X Cifu, MD VA Department of Physical Medicine and Rehabilitation
Principal Investigator: William C Walker, MD Virginia Commonwealth University (VCU)
PRS Account U.S. Army Medical Research and Development Command
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP