PoNS Clinical Experience Program in Traumatic Brain Injury Patients (TBI)

NCT03881176 | Completed DMC FDA Device

• 1 other identifier: NHC-TBI-PoNS-CE NORTHWELL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean change in balance score (Bertec) from baseline to the end of 14 weeks

  Baseline, 2 weeks, 5 weeks and 14 weeks

Study Arms (1)

Active

EXPERIMENTAL

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

Device: PoNS Treatment

Interventions

PoNS Treatment DEVICE

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

Active

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects must present with a chronic balance deficit due to mild-to-moderate TBI. However, other potentially related symptoms, such as gait disturbance, mild to moderate recurrent headaches, sleep, memory, attention, and cognitive deficits, will be noted on the data collection form at screening and each subsequent evaluation.
• At least 18 years of age, inclusive, at the time of screening.
• Acceptable results (as determined by the investigator) of a full history and physical performed or supervised by the investigator at each site. This will include a careful examination of the tongue and oral cavity for any abnormalities. History should include the nature and duration of any prior physical therapy program the subject may have participated in to address the balance and/or gait symptoms of their TBI. Prior participation in therapy is not a prerequisite for enrollment in the program
• Documentation on the history of a qualifying TBI, mild to moderate in severity. For reference, the Armed Forces Health Surveillance Branch (AFHSB) definitions of mild and moderate TBI will be used. The definitions are as follows:
• Mild TBI: Confused or disoriented state which lasts less than 24 hours; or loss of consciousness for up to 30 minutes, or memory loss lasting less than 24 hours. Excludes penetrating TBI.
• Moderate TBI: Confused or disoriented state which lasts more than 24 hours; and/or loss of consciousness for more than 30 minutes but less than 24 hours, or memory loss lasting greater than 24 hours but less than seven days; or meets criteria for Mild TBI except an abnormal CT scan is present. Excludes penetrating TBI.
• The investigator will ascertain whether the prior medical records and information collected during the clinical interview are sufficiently detailed to support the classification of the TBI.
• If female, the subject is not pregnant, not breastfeeding and has a negative pregnancy test prior to receipt of the PoNS device
• \- Note: Pregnancy testing will be repeated at end-of-study (EOS) (i.e., end of at-home period).
• If female is of childbearing potential, the subject agrees to use adequate contraception from screening and throughout the study period.
• A female of non-childbearing potential is defined as a subject who is postmenopausal (continuous amenorrhea for 12 months) or surgically sterile (defined as bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
• Balance disorder due to a mild-to-moderate traumatic brain injury (TBI), as indicated by the Bertec Balance Advantage - Sensory Organization Test (SOT) composite score at least 16 points below normal \[adjusted for age and height, based on normative data\].
• At least three (3) months post most recent TBI at the time of screening.
• Ambulatory and able to walk continuously over-ground or on a treadmill for 20 minutes, level grade (no inclination) and at any speed, with support, if needed.
• Able to understand the study procedures and give informed consent.

Sponsors & Collaborators

• Helius Medical Inc: lead
• North Shore University Hospital: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: September 21, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)