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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 up to 5 years
Awards & highlights

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 ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
The study site will deploy either PoNS Treatment Schedule A or PoNS Treatment Schedule B. Both PoNS Treatment Schedules 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 evening sessions and training sessions on weekends will always be performed independently, at-home by the subject

Find a Location

Who is running the clinical trial?

Transitions of Long IslandUNKNOWN
Helius Medical IncLead Sponsor
9 Previous Clinical Trials
356 Total Patients Enrolled
Neurohabilitation CorporationLead Sponsor
6 Previous Clinical Trials
216 Total Patients Enrolled
~3 spots leftby Sep 2025
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