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

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: NCT02109198
Recruitment Status : Withdrawn (protocol withdrawn)
First Posted : April 9, 2014
Last Update Posted : June 2, 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 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%.

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: Single (Participant)
Official Title: Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
Study Start Date : June 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active CN-NINM PoNS
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)

Placebo 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. Recruitment rate [ Time Frame: 36 weeks ]
    Number and percentage of subjects recruited over the 36 week pilot recruitment phase

  2. Completion and compliance rates [ Time Frame: Up to 12 weeks ]
    Number and percentage of subjects who complete the study

  3. Usability rating [ Time Frame: 12 weeks ]
    Number and percentage of subjects and therapists who rated usability as good or better.

  4. Success of blinding [ Time Frame: 12 weeks ]
    Number and percentage of subjects who accurately guess group membership

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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): NCT02109198


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: NCT02109198    
Other Study ID Numbers: CN-NINM pilot
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
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