PoNS Clinical Experience Program (TBI)

Mild to Moderate Traumatic Brain Injury Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Mild to Moderate Traumatic Brain Injury

• NCT number: NCT03881176
• Study type: Interventional
• Source: Neurohabilitation Corporation
• Contact: Denise McDermott
• Phone: 5162970864
• Email: dmcdermo@northwell.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2018
• Completion date: November 30, 2019