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StrokeEMAGINE-CNCT06979466

Q Therapeutic System for Chronic Stroke Recovery

A study testing Q Therapeutic System (BQ 3.0) - Active in people with Stroke and Hemorrhage, run by Burke Rehabilitation Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Hemorrhage, Brain Injury
What is being tested?
Q Therapeutic System (BQ 3.0) - Active
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
26 May 2025to 30 Jun 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

  • FMA-UE score between 22-50 (inclusive) of impaired limb.
  • Difference between Screening and Baseline visit FMA-UE is 3 points or fewer.
  • Age 18 to 80 years of age (inclusive).
  • Stroke due to ischemia or to intracerebral hemorrhage.
  • >6 months to 5 years from index stroke onset.
  • Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
Show all 12Show fewer
  • Able to sit with the investigational System for 40 consecutive minutes.
  • Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
  • Willingness to participate in physical exercises during study intervention sessions.
  • Availability of a relative or other caregiver able to assist during study treatment sessions and visits.
  • If female, not pregnant or breastfeeding or planning pregnancy during the study period.
  • Informed consent signed by subject.

Who cannot join

  • Severe neglect impairment interfering with assessments or treatments.
  • Severe depression, defined as GDS Score >10/15
  • The presence of MR-incompatible implanted devices or MR-incompatible retained objects; or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
  • 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
  • Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
  • Severe UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
Show all 14Show fewer
  • Pre-existing neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
  • Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
  • Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
  • Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
  • Participation in another interventional trial that would conflict with the current study or clinical endpoint interference may occur.
  • Participation in an upper extremity rehabilitation program provided by a licensed provider in the 4 weeks prior to the Screening visit, or a or planned participation in such program at any time between the Screening Visit and the primary endpoint visit.
  • Employee of the Sponsor.
  • Prisoner.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Josette Hartnett, MPH contact

9145972367

johartnett@burke.org

Andrew Abdou, DO contact

7327137373

aabdou@montefiore.org

United States1 site, 1 recruiting

  • Burke Rehabilitation Hospital

    White Plains, New York, 10605

    Josette Hartnett, MPH, 9142756481, johartnett@burke.org

    Andrew Abdou, DO, 7327137373, aabdou@montefiore.org

    Recruiting

Other trials in United States

About this study

Official title: Facilitation Recovery For Patients With Chronic Stroke: The Q Therapeutic System, Frequency-Tuned Electromagnetic Field Treatment

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

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. 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.

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.

Being tested
Q Therapeutic System (BQ 3.0) - Active
Keywords
BrainQ, Stroke, Cerebrovascular Disorders, Electromagnetic Stimulation
Medical subject headings
Stroke, Hemorrhage, Brain Injuries, Cerebrovascular Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Q Therapeutic System (BQ 3.0) - ActiveDevice

    Also called BQ 3.0 Active Stimulation Group Interventions

    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 groups in NCT06979466
Study groupRoleWhat they receive
BQ 3.0 Active Stimulation GroupExperimental60 sessions over a period of 12 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.
Receives: Device: Q Therapeutic System (BQ 3.0) - Active

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment - Upper Extremity

    a standardized, performance-based measure used to assess motor impairment in the upper limb following stroke or other neurological injuries

    Measured: Baseline, 3 month, 5 month, 6 month

Secondary outcomes (10)

  1. Box and Block Test

    Timed test used to assess unilateral gross manual dexterity

    Measured: Baseline, 3 month, 5 month, 6 month

  2. Geriatric Depression Scale (Short Form) (GDS)

    15-question self-administered questionnaire used to screen for depression in older adults. Each item is answered "Yes" or "No." One point is given for each answer that indicates depression (specific answers are predetermined). Score Range from 0-15. Interpretation: 0-4: Normal (no depression), 5-8: Mild depression, 9-11: Moderate Depression, 12-15: Severe Depression.

    Measured: Baseline, 3 month, 5 month, 6 month

  3. modified Rankin Scale (mRS)

    Tool to assess the degree of disability or dependence in daily activities following a stroke or other neurological event. Scores range from 0 (no symptoms), 1 (no significant disability) to 6 (death), with increasing scores indicating greater levels of disability.

    Measured: Baseline, 3 month, 5 month, 6 month

  4. Stroke Impact Scale (SIS) Hand Domain

    Assesses hand function through a self-report questionnaire with specific items focusing on how stroke has affected the individual's ability to use their hands in daily tasks. Each of the five items is rated on a 5-point scale from 1 (could not do at all) to 5 (not difficult at all), transformed to a 0-100 scale, where higher scores indicate better hand function. 0-19 (very severe difficulty or complete inability to use the hand), 20-39 (severe difficulty), 40-59 (moderate difficulty), 60-79 (mild difficulty), 80-100 (minimal or no difficulty with hand function).

    Measured: Baseline, 3 month, 5 month, 6 month

  5. Stroke Impact Scale 16 (SIS-16)

    16-item instrument designed to assess physical function in individuals with stroke. Each item is rated on a 5-point scale from 1 (could not do it at all) to 5 (not difficult at all) and the total raw score is transformed to a 0-100 scale, with higher scores indicating better physical functioning. 0-19 (very severe limitations, unable to perform most physical tasks independently), 20-39 (severe physical limitations, significant dependence on others), 40-59 (moderate physical limitations, difficult with many daily activities), 60-79 (mild physical limitations, may need some assistance or accommodations), 80-100 (minimal to no physical limitations, high level of independence)

    Measured: Baseline, 3 month, 5 month, 6 month

  6. Nine Hole Peg Test (9HPT)

    Standardized, quantitative assessment used to evaluate finger dexterity

    Measured: Baseline, 3 month, 5 month, 6 month

  7. 10 Meter Walk Test (10MWT)

    Standardized assessment used to measure gait speed, a key indicator of functional mobility

    Measured: Baseline, 3 month, 5 month, 6 month

  8. Functional Ambulation Categories (FAC)

    6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking. Scores range from 0 (non-functional ambulation) to 5 (independent ambulation on all surfaces including stairs). Higher scores indicate greater walking independence

    Measured: Baseline, 3 month, 5 month, 6 month

  9. 5-level EQ-5D (EQ-5D-5L)

    Brief, multi-attribute, generic health status measure that uses a descriptive system and a visual analogue scale (EQ-VAS). Five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is rated on a 5-level scale, from no problems (1) to extreme problems (5), generating a 5-digit health state that is converted into an index value (typically 0 = death to 1 = full health, with possible negative values for health states worse than death). A higher index score indicates better perceived overall health status, and a visual analog scale (VAS) is also included to rate health from 0 (worst) to 100 (best imaginable health).

    Measured: Baseline, 3 month, 5 month, 6 month

  10. Berg Balance Scale (BBS)

    Non mandatory assessment - 14-item functional test designed to assess balance and risk of falls in older adults, but it can also be used with other populations. Each item is scored from 0 to 4, with a maximum total score of 56, where higher scores indicate better balance. Scores 41-56 suggest low fall risk, 21-40 indicate moderate risk, and 0-20 reflect a high risk of falling and significant balance impairment.

    Measured: Baseline, 3 month, 5 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2025
  2. Study start26 May 2025
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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
Model description
This is a prospective, single-arm, open-label, single center clinical trial designed to evaluate the efficacy, and safety of the intervention in the management of chronic stroke patients.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06979466
Sponsor's protocol ID
BRH_EMAGINE C IIT_202501
Acronym
EMAGINE-C
Status last verified
Aug 2025
First submitted
13 May 2025
Last updated
12 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified IPD will be shared with the study sponsor.

Publications

  • Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022.

    PubMed 36452175

  • Saver JL, Duncan PW, Stein J, Cramer SC, Eng JJ, Lifshitz A, Hochberg A, Bornstein NM. EMAGINE-Study protocol of a randomized controlled trial for determining the efficacy of a frequency tuned electromagnetic field treatment in facilitating recovery within the subacute phase following ischemic stroke. Front Neurol. 2023 May 5;14:1148074. doi: 10.3389/fneur.2023.1148074. eCollection 2023.

    PubMed 37213907

  • Segal Y, Segal L, Blumenfeld-Katzir T, Sasson E, Poliansky V, Loeb E, Levy A, Alter A, Bregman N. The Effect of Electromagnetic Field Treatment on Recovery from Ischemic Stroke in a Rat Stroke Model: Clinical, Imaging, and Pathological Findings. Stroke Res Treat. 2016;2016:6941946. doi: 10.1155/2016/6941946. Epub 2016 Feb 1.

    PubMed 26949561

  • Okabe N, Hovanesyan M, Azarapetian S, Dai W, Weisinger B, Parabucki A, Balter SR, Shohami E, Segal Y, Carmichael ST. Theta Frequency Electromagnetic Stimulation Enhances Functional Recovery After Stroke. Transl Stroke Res. 2025 Apr;16(2):194-206. doi: 10.1007/s12975-023-01202-z. Epub 2023 Nov 14.

    PubMed 37962771

Questions about this trial

What is this clinical trial studying?

A study testing Q Therapeutic System (BQ 3.0) - Active in people with Stroke and Hemorrhage, run by Burke Rehabilitation Hospital at 1 site in United States.

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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Josette Hartnett, MPH (9145972367, johartnett@burke.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment - Upper Extremity (time frame: Baseline, 3 month, 5 month, 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06979466, which also lists 4 linked publications.

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 12 Aug 2025.

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