- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02109198
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Trial)
May 29, 2015 updated by: U.S. Army Medical Research and Development Command
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Pilot Phase)
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%.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Virginia
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Richmond, Virginia, United States, 23249
- McGuire Veterans Affairs Medical Center
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Richmond, Virginia, United States, 23298-3038
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Veteran or Servicemember
- 18 to 50 years old
- Sustained one or more mild traumatic brain injury (mTBI)s
- 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))
- Available for the duration of the study
Exclusion Criteria:
- History of traumatic brain injury (TBI) of any severity other than mild TBI
- Presence of active substance abuse condition
- Any condition for which posturography is contraindicated (e.g. leg amputation or fracture)
- Diagnosed neurological disorder with balance sequelae, other than TBI (e.g. Parkinson's disease, incomplete spinal cord injury, or Multiple Sclerosis)
Orthostatic hypotension as defined by:
- A systolic blood pressure decrease (from supine to sitting) of at least 20 mmHg
- A diastolic blood pressure decrease of at least 10 mmHg, or
- A pulse increase of 30 beats or more per minute with associated signs or symptoms of cerebral hypoperfusion
- An implanted medical device
- Pregnancy
- Oral infection
- Known transmissible disease (HIV, hepatitis, influenza, TB)
- Exam signs of serious disorder other than mTBI as defined by facial asymmetry, hoarseness and dysarthria (e.g. tumor, stroke).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
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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:
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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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sensory Organization Test (SOT)
Time Frame: 12 weeks
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Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
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12 weeks
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Recruitment rate
Time Frame: 36 weeks
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Number and percentage of subjects recruited over the 36 week pilot recruitment phase
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36 weeks
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Completion and compliance rates
Time Frame: Up to 12 weeks
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Number and percentage of subjects who complete the study
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Up to 12 weeks
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Usability rating
Time Frame: 12 weeks
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Number and percentage of subjects and therapists who rated usability as good or better.
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12 weeks
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Success of blinding
Time Frame: 12 weeks
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Number and percentage of subjects who accurately guess group membership
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: David X Cifu, MD, VA Department of Physical Medicine and Rehabilitation
- Principal Investigator: William C Walker, MD, Virginia Commonwealth University (VCU)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Anticipated)
August 1, 2016
Study Completion (Anticipated)
August 1, 2016
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 7, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Estimate)
June 2, 2015
Last Update Submitted That Met QC Criteria
May 29, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-NINM pilot
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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