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Study of Safety and Effectiveness of PoNS Device to Treat Chronic Balance Deficit Due to Traumatic Brain Injury (TBI)

NCT02429167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2020-02-07

No results posted yet for this study

Summary

The purpose of this study is to determine if clinic and home training with a study device will improve a balance deficit. The study device is called Portable Neuromodulation Stimulator (PoNS). The study device will be placed on the tongue to deliver nerve stimulation. The study is testing if use of the study device in conjunction with physical therapy will improve balance and gait in patients suffering from a TBI. The effects of using the device and undergoing therapy will be measured using standardized tests of movement control, gait, headache and other TBI symptoms.

Conditions

Interventions

DEVICE

Cranial nerve non-invasive neuromodulation via PoNS device

The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.

DEVICE

Sham PoNS device

The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. The sham control device is physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, minimizing any neuromodulatory effect. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.

Sponsors & Collaborators

  • Helius Medical Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2017-08-18
Completion
2017-08-18

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02429167 on ClinicalTrials.gov