MedTrace Logo

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

NCT02125591 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-05-22

No results posted yet for this study

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

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
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-11-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT02125591 on ClinicalTrials.gov