Brain Injury, Cerebrovascular Accident (CVA), Chronic Stroke Patient, Hemorrhage, Stroke
Conditions
Keywords
BrainQ, Stroke, Cerebrovascular Disorders, Electromagnetic Stimulation
Brief 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.
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.
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
Sponsors
BrainQ Technologies Ltd.
Burke Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
Exclusion criteria
* 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 * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity | Baseline, 3 month, 5 month, 6 month | a standardized, performance-based measure used to assess motor impairment in the upper limb following stroke or other neurological injuries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geriatric Depression Scale (Short Form) (GDS) | Baseline, 3 month, 5 month, 6 month | 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. |
| modified Rankin Scale (mRS) | Baseline, 3 month, 5 month, 6 month | 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. |
| Stroke Impact Scale (SIS) Hand Domain | Baseline, 3 month, 5 month, 6 month | 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). |
| Stroke Impact Scale 16 (SIS-16) | Baseline, 3 month, 5 month, 6 month | 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) |
| Box and Block Test | Baseline, 3 month, 5 month, 6 month | Timed test used to assess unilateral gross manual dexterity |
| 10 Meter Walk Test (10MWT) | Baseline, 3 month, 5 month, 6 month | Standardized assessment used to measure gait speed, a key indicator of functional mobility |
| Functional Ambulation Categories (FAC) | Baseline, 3 month, 5 month, 6 month | 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 |
| 5-level EQ-5D (EQ-5D-5L) | Baseline, 3 month, 5 month, 6 month | 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). |
| Berg Balance Scale (BBS) | Baseline, 3 month, 5 month, 6 month | 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. |
| Nine Hole Peg Test (9HPT) | Baseline, 3 month, 5 month, 6 month | Standardized, quantitative assessment used to evaluate finger dexterity |
Countries
United States
Contacts
Primary ContactJosette Hartnett, MPH
Backup ContactAndrew Abdou, DO
Outcome results
None listed