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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05437276
Study type Observational
Source Helius Medical Inc
Contact Antonella Favit-VanPelt, MD, PhD
Phone 2159446102
Email afavitvanpelt@heliusmedical.com
Status Recruiting
Phase
Start date July 1, 2022
Completion date July 2024