NCT07499310

The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures. Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability. Aim 2: Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

Detailed description

STUDY DESIGN: * This 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 management of chronic stroke patients. * While this trial is conducted as a single-center Investigator-Initiated Trial (IIT), additional sites have initiated comparable IITs following a similar trial design. These sites will adhere to the core aspects of the study, with a prospective intent to pool results across sites into a primary pooled analysis, following a formal statistical plan. * All enrolled participants will undergo treatment with the investigational device according to the defined study protocol. * Primarily, the trial will assess the system's impact on the upper extremity function through objective, validated clinical assessments. Secondary endpoints will evaluate additional functional and global disability, quality-of-life and safety outcomes. * As a single-arm study, all participants will serve as their own control, with baseline measurements collected prior to device intervention and compared to post-treatment outcomes.

Conditions

• Stroke
• Chronic Stroke Patients

Interventions

Type	Name	Description
DEVICE	Experimental (Q Therapeutic System (BQ 3.0)	Device: Q Therapeutic System (BQ 3.0) - Active The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-03-30
• Last updated: 2026-03-30

Regulatory

• FDA-regulated device study