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

NCT ID: NCT02109198

Last Updated: 2015-06-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Active CN-NINM PoNS

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

Sham CN-NINM PoNS

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

Active cranial-nerve non-invasive neuromodulation (CN-NINM); Portable Neuromodulation Stimulator (PoNS)

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

The Defense and Veterans Brain Injury Center

FED

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David X Cifu, MD

Role: PRINCIPAL_INVESTIGATOR

VA Department of Physical Medicine and Rehabilitation

William C Walker, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University (VCU)

Locations

McGuire Veterans Affairs Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CN-NINM pilot

Identifier Type: -

Identifier Source: org_study_id