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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Recruitment Status : Withdrawn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

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).

Condition or disease Intervention/treatment Phase
Mild Traumatic Brain Injury Device: Active CN-NINM PoNS Device: Sham CN-NINM PoNS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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)

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI) [ Time Frame: 12 weeks ]
  2. Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI) [ Time Frame: 12 weeks ]
  3. Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ) [ Time Frame: 12 weeks ]
  4. Change in quality of life measured using Short Form 36 (SF-36) [ Time Frame: 12 weeks ]
  5. Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C) [ Time Frame: 12 weeks ]
  6. 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.

  7. 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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02125591


Locations
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United States, Virginia
McGuire Veterans Affairs Medical Center
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-3038
Sponsors and Collaborators
U.S. Army Medical Research and Development Command
Virginia Commonwealth University
US Department of Veterans Affairs
The Defense and Veterans Brain Injury Center
Investigators
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Principal Investigator: David X Cifu, MD VA Department of Physical Medicine and Rehabilitation
Principal Investigator: William C Walker, MD Virginia Commonwealth University (VCU)

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Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT02125591    
Other Study ID Numbers: CN-NINM full
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: October 2014
Keywords provided by U.S. Army Medical Research and Development Command:
Mild Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating