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

NCT02109198 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-06-02

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Virginia Commonwealth University

    collaborator OTHER

  • US Department of Veterans Affairs

    collaborator FED

  • The Defense and Veterans Brain Injury Center

    collaborator FED

  • U.S. Army Medical Research and Development Command

    lead FED

Principal Investigators

  • David X Cifu, MD · VA Department of Physical Medicine and Rehabilitation

  • William C Walker, MD · Virginia Commonwealth University (VCU)

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109198 on ClinicalTrials.gov