Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT07095920
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RESPARK - Brain Q for Chronic Stroke
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke
Status:
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:
This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. This trial is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the rehabilitation of people with chronic stroke.
Detailed Description:
The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 60 sessions. Each participant must complete at least 40 sessions over the 12-week period to complete the protocol. No extra time will be given to complete all 60 sessions. Each session will last up to 60 minutes during which 40 minutes of active stimulation using the BQ 3.0 System will be administered to participants. The 40 minutes of stimulation will be paired with seated upper extremity (UE) exercises. Lastly, the device will be removed and 10 minutes of standing balance and LE strengthening exercises will be performed without stimulation. A battery of clinical assessments will be conducted before and after the 60 exercise sessions.
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?: