NCT03732755

PoNS Clinical Experience Program (TBI)

An Open-label Study of Safety and Effectiveness of the Portable Neuromodulation Stimulator (PoNS®) Treatment for Subjects With a Chronic Balance Deficit Due to Mild-to-moderate Traumatic Brain Injury (TBI)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Helius Medical Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2018-11-07
• Last updated: 2019-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study