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

Cranial-nerve Non-invasive Neuromodulation (CN-NINM) for Balance Deficits After Mild Traumatic Brain Injury: A Randomized, Double-Blinded, Sham-Controlled, Prospective Trial

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).

Study Overview

• Status: Withdrawn
• Conditions: Mild Traumatic Brain Injury
• Intervention / Treatment: Device: Active CN-NINM PoNS; Device: Sham CN-NINM PoNS

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire Veterans Affairs Medical Center
    • Richmond, Virginia, United States, 23298-3038
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sensory Organization Test (SOT)	Comparison of the SOT score between the treatment group and sham group at the intermediate follow-up.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in post-concussive symptoms using Neurobehavioral Symptom Inventory (NSI)		12 weeks
Change in dizziness and unsteadiness measured by Dizziness Handicap Inventory (DHI)		12 weeks
Change in space and motion discomfort measured by Situational Characteristics Questionnaire (SitQ)		12 weeks
Change in quality of life measured using Short Form 36 (SF-36)		12 weeks
Change in symptoms of post-traumatic stress disorder (PTSD) measured using the unspecified PTSD checklist (PCL-C)		12 weeks
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.	12 weeks
Change in neuroimaging using functional magnetic resonance imaging (fMRI)	For fMRI, a repeated single-shot echo-planar imaging will be acquired	12 weeks

Collaborators and Investigators

• Sponsor: U.S. Army Medical Research and Development Command
• Collaborators: US Department of Veterans Affairs; Virginia Commonwealth University; The Defense and Veterans Brain Injury Center
• 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

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Mild Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: CN-NINM full

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No