Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06336720
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-18
Brief Title:
PoNS Therapy for Gait and Balance Deficits in Chronic Stroke Survivors A Single-Arm Study
Sponsor:
Helius Medical Inc
Organization:
Helius Medical Inc
Study Overview
Official Title:
Portable Neuromodulation Stimulator PoNS Therapy for Gait and Balance Deficits in Chronic Stroke Survivors A Single-Arm Study
Status:
RECRUITING
Status Verified Date:
2024-03
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 11 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 participants ability level and instruct on how to perform the breathing and awareness mindfulness training BAT To ensure patients 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 participants 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 11 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 participants ability level and instruct on how to perform the breathing and awareness mindfulness training BAT To ensure patients 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 participants 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:
None
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?:
None
Is an FDA AA801 Violation?:
None