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| Name | Class |
|---|---|
| BrainQ Technologies Ltd. | INDUSTRY |
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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.
STUDY DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months after, and 6 months after start of interventions |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Cumulative incidence of adverse events | The number of adverse events reported throughout the study. | Initial consent to final study visit (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
A. 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.
D. Severe upper extremity spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score ≥3 in either biceps or chest muscles.
E. 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghaith J. Androwis, PhD | Contact | 201-968-6110 | GAndrowis@kesslerfoundation.org | |
| Steven Kirshblum, MD | Contact | skirshblum@selectmedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Ghaith J Androwis, PhD | Kessler Foundation | Principal Investigator |
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|
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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