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PoNS Clinical Experience Program (TBI)

NCT03732755 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-20

No results posted yet for this study

Summary

\- Brief Summary: Prospective, cohort, open-label study. The cohort consists of people who have a chronic balance dysfunction due to a mild to moderate traumatic brain injury (TBI). All participants will participate in a 14-week PoNS Treatment protocol - a combination of symptom specific physical exercises and repeated use of the PoNS device.

Subjects who meet the initial screening entrance criteria will be scheduled for a baseline assessment to evaluate balance and gait. Subjects will then begin the PoNS Treatment program and re-perform some assessments at 2, 5 and 14 weeks evaluating their functional improvements.

Conditions

  • Mild to Moderate Traumatic Brain Injury

Interventions

DEVICE

PoNS Treatment

PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week. Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3: Morning: Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions Afternoon: Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS Evening: Breathing and Awareness Training with PoNS To be performed at home during all stages

Sponsors & Collaborators

  • Kessler Institute for Rehabilitation

    collaborator INDUSTRY

  • Helius Medical Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-11-30
Completion
2019-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03732755 on ClinicalTrials.gov