StrokeRESPARKNCT07499310
The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.
A study testing Experimental (Q Therapeutic System (BQ 3.0) in people with Stroke and Chronic Stroke Patients, run by Kessler Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Chronic Stroke Patients
- What is being tested?
- Experimental (Q Therapeutic System (BQ 3.0)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between ages 18-80
- Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
- Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
- Have stroke due to ischemia or to intracerebral hemorrhage • Be >6 months to 5 years from stroke onset
- Have a Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit
- Be able to sit with the investigational System for 40 consecutive minutes
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- Be able to follow a 3-step command in English, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent
- Have the willingness to participate in physical exercises during study intervention sessions.
- Be sure of the availability of a relative, friend, or other non-hired caregiver to be able to assist during program sessions and study visits, as needed
Who cannot join
- Be younger than 18 years old or older than 80
- Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
- Have conditions other than stroke, such as:
- Severe neglect impairment interfering with assessments or treatments. B. Severe depression, defined as GDS Score >10/15 C. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years.
- Severe upper extremity spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score ≥3 in either biceps or chest muscles.
- Pre-existing neurological condition (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with my participation in the study and/or confound neurological or functional evaluation F. Unstable serious illness/condition (such as active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with my participation in the study and/or confoundneurological or functional evaluation
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- Have alcohol abuse and/or drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial
- Had active participation in an arm rehabilitation program with a therapist in the 4 weeks prior to the screening visit
- Plan to have an arm rehabilitation program with a therapist between the screening visit and the assessment visit at 3-months
- Be an employee of Kessler Foundation
- Be a prisoner
- Be pregnant or breastfeeding or planning pregnancy during the study period.
- Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Steven Kirshblum, MD contact
About this study
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.
Read the 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
- Being tested
- Experimental (Q Therapeutic System (BQ 3.0)
- Keywords
- BrainQ Electromagnetic Stimulation, upper extremity, rehabilitation, exercise mobility
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental (Q Therapeutic System (BQ 3.0)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Treatment | Experimental | Participants will complete 5-7 treatment sessions per week over a 12-week period, with no more than one session per day. Up to the first seven sessions will be conducted at Kessler Foundation, after which the remaining sessions will be performed at home with caregiver assistance as needed. Each session will last up to 60 minutes, including up to 40 minutes with the stimulation field active. During each session, participants will engage in guided physical exercise activities delivered through an app while wearing the BQ device on the head (see image below). Participants who wish to continue beyond the initial 3-month period may opt to extend treatment for an additional 8 weeks, following a similar schedule of 5-7 sessions per week. Receives: Device: Experimental (Q Therapeutic System (BQ 3.0) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of FMA-UE score
Mean change of FMA-UE score from Baseline to the 3-months follow-up visit. A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
Measured: Baseline, 3 months after, and 6 months after start of interventions
Secondary outcomes (1)
Safety endpoints: Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
Measured: Initial consent to final study visit (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- BrainQ Technologies Ltd.
- Responsible party
- Principal investigator, Ghaith J. Androwis, Ph.D., Kessler Foundation
- Investigators
- Ghaith J Androwis, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499310
- Sponsor's protocol ID
- R-1296-25
- Acronym
- RESPARK
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.
- ClinicalTrials.gov ID
- NCT07499310
- Acronym / sponsor ID
- RESPARK / R-1296-25
- Conditions
- Stroke, Chronic Stroke Patients
- Keywords
- BrainQ Electromagnetic Stimulation, upper extremity, rehabilitation, exercise mobility
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- BrainQ Technologies Ltd.
- Study start
- Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention/Treatment | Experimental | Device: Experimental (Q Therapeutic System (BQ 3.0)Participants will complete 5-7 treatment sessions per week over a 12-week period, with no more than one session per day. Up to the first seven sessions will be conducted at Kessler Foundation, after which the remaining sessions will be performed at home with caregiver assistance as needed. Each session will last up to 60 minutes, including up to 40 minutes with the stimulation field active. During each session, participants will engage in guided physical exercise activities delivered through an app while wearing the BQ device on the head (see image below). Participants who wish to continue beyond the initial 3-month period may opt to extend treatment for an additional 8 weeks, following a similar schedule of 5-7 sessions per week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be between ages 18-80
- Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
- Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
- Have stroke due to ischemia or to intracerebral hemorrhage • Be >6 months to 5 years from stroke onset
- Have a Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit
Key exclusion criteria (13 listed)
- Be younger than 18 years old or older than 80
- Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
- Have conditions other than stroke, such as:
- Severe neglect impairment interfering with assessments or treatments. B. Severe depression, defined as GDS Score >10/15 C. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years.
- Severe upper extremity spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score ≥3 in either biceps or chest muscles.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Intervention/Treatment |
Primary outcome
Mean change of FMA-UE score
Time frame: Baseline, 3 months after, and 6 months after start of interventions
Mean change of FMA-UE score from Baseline to the 3-months follow-up visit. A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
1 secondary outcome
Safety endpoints: Cumulative incidence of adverse events
Time frame: Initial consent to final study visit (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Kirshblum, MD contact
Ghaith J Androwis, PhD principal investigator
Kessler Foundation
Questions about this trial
What is this clinical trial studying?
A study testing Experimental (Q Therapeutic System (BQ 3.0) in people with Stroke and Chronic Stroke Patients, run by Kessler Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ghaith J. Androwis, PhD (201-968-6110, GAndrowis@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change of FMA-UE score (time frame: Baseline, 3 months after, and 6 months after start of interventions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.