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Behavioural Intervention

Active for Traumatic Brain Injury

N/A
Waitlist Available
Research Sponsored by Helius Medical Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks, 5 weeks and 14 weeks
Awards & highlights

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.

Eligible Conditions
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks, 5 weeks and 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 5 weeks and 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change in balance score (SOT) from baseline to the end of 14 weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Helius Medical IncLead Sponsor
8 Previous Clinical Trials
296 Total Patients Enrolled
Baylor Institute for RehabilitationOTHER
3 Previous Clinical Trials
5,684 Total Patients Enrolled
Neurohabilitation CorporationLead Sponsor
6 Previous Clinical Trials
216 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PoNS Clinical Experience Program (TBI)
2019. "PoNS Clinical Experience Program (TBI)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03852732.
All > Tb
~3 spots leftby May 2025
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