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

NCT02125591 | Withdrawn

• 1 other identifier: CN-NINM full
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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).

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Active PoNS CN-NINM

EXPERIMENTAL

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

Sham PoNS CN-NINM

SHAM COMPARATOR

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

Interventions

Active CN-NINM PoNS DEVICE

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.

Also known as: Active cranial-nerve non-invasive neuromodulation (CN-NINM), Portable Neuromodulation Stimulator (PoNS)

Active PoNS CN-NINM

Sham CN-NINM PoNS DEVICE

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.

Sham PoNS CN-NINM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Veteran or Servicemember
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (2)

McGuire Veterans Affairs Medical Center

Richmond, Virginia, 23249, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298-3038, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• David X Cifu, MD

  VA Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

• William C Walker, MD

  Virginia Commonwealth University (VCU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 29, 2014
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 22, 2015

Record last verified: 2014-10

Locations

US (2)