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| Name | Class |
|---|---|
| BrainQ Technologies Ltd. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BQ 3.0 Active Stimulation Group | Experimental | 60 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q Therapeutic System (BQ 3.0) - Active | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, 3 month, 5 month, 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Box and Block Test | Timed test used to assess unilateral gross manual dexterity | Baseline, 3 month, 5 month, 6 month |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josette Hartnett, MPH | Contact | 9145972367 | johartnett@burke.org | |
| Andrew Abdou, DO | Contact | 7327137373 | aabdou@montefiore.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Rehabilitation Hospital | Recruiting | White Plains | New York | 10605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36452175 | Background | 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. | |
| 37213907 |
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De-identified IPD will be shared with the study sponsor.
IPD will be shared from July 2025 to Dec 2026 between the site and study sponsor.
De-identified data in excel spreadsheets will me made available to the study sponsor.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006470 | Hemorrhage |
| D001930 | Brain Injuries |
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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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.
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| Baseline, 3 month, 5 month, 6 month |
| 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. | Baseline, 3 month, 5 month, 6 month |
| 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). | Baseline, 3 month, 5 month, 6 month |
| 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) | Baseline, 3 month, 5 month, 6 month |
| Nine Hole Peg Test (9HPT) | Standardized, quantitative assessment used to evaluate finger dexterity | Baseline, 3 month, 5 month, 6 month |
| 10 Meter Walk Test (10MWT) | Standardized assessment used to measure gait speed, a key indicator of functional mobility | Baseline, 3 month, 5 month, 6 month |
| 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 | Baseline, 3 month, 5 month, 6 month |
| 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). | Baseline, 3 month, 5 month, 6 month |
| 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. | Baseline, 3 month, 5 month, 6 month |
| Background |
| 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. |
| 26949561 | Background | 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. |
| 37962771 | Background | 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. |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |