Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06336720
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2024-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PoNS® Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Sponsor:
Helius Medical Inc
Organization:
Study Overview
Official Title:
Portable Neuromodulation Stimulator (PoNS®) Therapy for Gait and Balance Deficits in Chronic Stroke Survivors: A Single-Arm Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective: To further evaluate the aspects of safety related to PoNS therapy in chronic stroke survivors.
Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.
Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.
Secondary Objectives: To further evaluate the efficacy of PoNS on improving dynamic gait and balance, establishing durability of effect, risk of falling and fall rate. As well as adherence to PoNS device utilization.
Exploratory Objectives: To further evaluate quality of life to measure physical, mental, behavioral, and general health, as well as functional decline (\> 30% on gait or balance improvement at endpoint) during the 12-week follow-up.
Detailed Description:
Observational, interventional, single-arm, open label, clinical trial investigating PoNS utilization with combined with dynamic gait and balance rehabilitation exercise (DGB training) in chronic stroke survivors.
6 The data from this prospective, single arm, multi-site, study that will enroll 30 subjects at 3 different clinical sites will be used to augment safety data obtained in the RCT (which will randomize 60 patients 1:1 into either active PoNS combined with DGB training versus DGB training with a sham device). The totality of the proposed clinical evidence spans 3-4 sites and approximately 90 patients.
Eligible study participants in this study will be assigned to treatment with a PoNS device \["active"\]. Participants will work with a study physical therapist - trained on PoNS Therapy by HMI Medical and registered as a PoNS Trainer (Trainer). The Trainer will prepare a DGB training exercise program appropriate to the participant's ability level and instruct on how to perform the breathing and awareness (mindfulness) training (BAT). To ensure patient's safety during rehabilitation at home, the Trainer may assign a DGB training program slightly different from the one performed in clinic.
All participants will undergo a total of twelve weeks of DGB training program, performed both in clinic (4 weeks, Part 1), supervised by the Trainer, and at home (8 weeks, Part 2), unsupervised. At the end of the treatment period, they will be asked to return to the clinic site for the follow-up visit 12 weeks after the end of the treatment period, as shown below:
During the training sessions in clinic and, subsequently, during at-home training period, the trainer can adjust /flex the DGB training based on the participant's individual response to PoNS Therapy. During Phase 2, the Trainer will follow-up weekly with participants either in person, or through a telemedicine session, if patient is unavailable to travel to the clinic.
Twelve weeks after completing the 12-week treatment phase of the study, participants will be required to return to the clinic for the final assessment of treatment effect. During the 12-week follow-up period (Part 3), participants will no longer utilize PoNS device but will still be encouraged to continue with their physical rehabilitation program for the duration follow-up period until the final study visit.
6 The data from this prospective, single arm, multi-site, study that will enroll 30 subjects at 3 different clinical sites will be used to augment safety data obtained in the RCT (which will randomize 60 patients 1:1 into either active PoNS combined with DGB training versus DGB training with a sham device). The totality of the proposed clinical evidence spans 3-4 sites and approximately 90 patients.
Eligible study participants in this study will be assigned to treatment with a PoNS device \["active"\]. Participants will work with a study physical therapist - trained on PoNS Therapy by HMI Medical and registered as a PoNS Trainer (Trainer). The Trainer will prepare a DGB training exercise program appropriate to the participant's ability level and instruct on how to perform the breathing and awareness (mindfulness) training (BAT). To ensure patient's safety during rehabilitation at home, the Trainer may assign a DGB training program slightly different from the one performed in clinic.
All participants will undergo a total of twelve weeks of DGB training program, performed both in clinic (4 weeks, Part 1), supervised by the Trainer, and at home (8 weeks, Part 2), unsupervised. At the end of the treatment period, they will be asked to return to the clinic site for the follow-up visit 12 weeks after the end of the treatment period, as shown below:
During the training sessions in clinic and, subsequently, during at-home training period, the trainer can adjust /flex the DGB training based on the participant's individual response to PoNS Therapy. During Phase 2, the Trainer will follow-up weekly with participants either in person, or through a telemedicine session, if patient is unavailable to travel to the clinic.
Twelve weeks after completing the 12-week treatment phase of the study, participants will be required to return to the clinic for the final assessment of treatment effect. During the 12-week follow-up period (Part 3), participants will no longer utilize PoNS device but will still be encouraged to continue with their physical rehabilitation program for the duration follow-up period until the final study visit.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: