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

NCT02109198 | Withdrawn

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

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%.

Conditions

Mild Traumatic Brain Injury

Keywords

Mild Traumatic Brain Injury

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

  Number and percentage of subjects recruited over the 36 week pilot recruitment phase

  36 weeks

• Completion and compliance rates

  Number and percentage of subjects who complete the study

  Up to 12 weeks

• Usability rating

  Number and percentage of subjects and therapists who rated usability as good or better.

  12 weeks

• Success of blinding

  Number and percentage of subjects who accurately guess group membership

  12 weeks

• 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

Study Arms (2)

Active CN-NINM PoNS

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

PLACEBO 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 CN-NINM PoNS

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: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 9, 2014
• Study Start: June 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

US (2)