A Therapeutic Experience Program (TEP) Study for Improvement of Gait in People with Multiple Sclerosis (MS) (PoNSTEP)

Helius Medical

Status: Completed

Conditions: Gait Impairment Due to Mild/moderate Multiple Sclerosis (MS)

Treatments: Device: PoNS®

Study type: Observational

Funder types: Industry

Identifiers

NCT05437276

HMI-MS-PoNS-TE001

Details and patient eligibility

About

PoNS therapy is a rehabilitation program that uses the PoNS device in conjunction with individualized physical exercise. This is an outcome research open label observational interventional multi-center study investigating the relationship between subject's adherence to PoNS therapy and therapeutic outcomes.

Full description

Study participants will undergo fourteen weeks of on-label PoNS therapy and, specifically, two weeks in-clinic PoNS therapy directly supervised by a physical therapist who has been trained on PoNS therapy by Helius Medical and certified as a clinic PoNS trainer (Phase 1) followed by 12 weeks of at-home unsupervised PoNS therapy Once weekly in-clinic PoNS therapy session (Phase 2). Subjects will be then asked to return to the clinic six month after the end of the study Phase 2 to assess maintenance of PoNS therapy effects.

Enrollment: 43 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women ≥ 22 years of age with a diagnosis of MS.
2. EDSS scores < 6.5 at screening; a demonstrated gait deficit.
3. Can walk at least 10 meters with or without the use of walking aids.
4. Participants must be stable without relapse for at least 60 days and agree to PoNS therapy regimen.

Exclusion criteria

1. Other neurological, visual, or orthopedic problems that significantly interfere with balance or gait.
2. Dementia.
3. Subjects who are currently attending physical rehabilitation and are unwilling to switch to PoNS-specific physical therapy regimen.
4. Subjects who are already functional community ambulators (gait speed>120cm/s43).
5. Subjects will also be excluded as per the Helius Medical PoNS device indication for usage ("electrical stimulation should not be used: if there is an active or suspected malignant tumor; in areas of recent bleeding or open wounds; in areas that lack normal sensation; in women who are pregnant, or in people with sensitivity to nickel, gold or copper").

Trial design

43 participants in 1 patient group

People with mild to moderate Multiple Sclerosis and gait deficit

Description:

All enrolled subjects will go through 14 weeks therapy: Phase 1 (2-week in-clinic supervised PoNS therapy) followed by Phase 2 (12-week period of at-home unsupervised - PoNS therapy). Six-Month Observation: subjects will be asked to return to the clinic six months after the end of the 14-week course of therapy for an observation visit. Individual subjects could receive, upon investigator's opinion of need, an ad hoc second 12-week course of PoNS therapy.

Treatment:

Device: PoNS®