Back to resultsCranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial) (CN-NINM)
Primary Purpose
Mild Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active CN-NINM PoNS
Sham CN-NINM PoNS
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Mild Traumatic Brain Injury
Eligibility Criteria
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).
Sites / Locations
- McGuire Veterans Affairs Medical Center
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active PoNS CN-NINM
Sham PoNS CN-NINM
Arm Description
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
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
Outcomes
Primary Outcome Measures
Change in Sensory Organization Test (SOT)
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Secondary Outcome Measures
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)
Change in quality of life measured using Short Form 36 (SF-36)
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)
DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
Change in neuroimaging using functional magnetic resonance imaging (fMRI)
For fMRI, a repeated single-shot echo-planar imaging will be acquired
Full Information
NCT ID
NCT02125591
First Posted
April 7, 2014
Last Updated
May 21, 2015
Sponsor
U.S. Army Medical Research and Development Command
Collaborators
Virginia Commonwealth University, US Department of Veterans Affairs, The Defense and Veterans Brain Injury Center
1. Study Identification
Unique Protocol Identification Number
NCT02125591
Brief Title
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)
Acronym
CN-NINM
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Study Start Date
August 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
Collaborators
Virginia Commonwealth University, US Department of Veterans Affairs, The Defense and Veterans Brain Injury Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Mild Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active PoNS CN-NINM
Arm Type
Experimental
Arm Description
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
Arm Title
Sham PoNS CN-NINM
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Active CN-NINM PoNS
Other Intervention Name(s)
Active cranial-nerve non-invasive neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham CN-NINM PoNS
Intervention Description
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 Measure Information:
Title
Change in Sensory Organization Test (SOT)
Description
Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)
Time Frame
12 weeks
Title
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)
Time Frame
12 weeks
Title
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)
Time Frame
12 weeks
Title
Change in quality of life measured using Short Form 36 (SF-36)
Time Frame
12 weeks
Title
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)
Time Frame
12 weeks
Title
Change on neural organization in tracts controlling balance using diffusion tensor imaging (DTI)
Description
DTI will be acquired using 3.0T field strength Siemens Trio MRI scanner.
Time Frame
12 weeks
Title
Change in neuroimaging using functional magnetic resonance imaging (fMRI)
Description
For fMRI, a repeated single-shot echo-planar imaging will be acquired
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David X Cifu, MD
Organizational Affiliation
VA Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William C Walker, MD
Organizational Affiliation
Virginia Commonwealth University (VCU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGuire Veterans Affairs Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-3038
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury (Full Trial)
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