BridgeMD
New treatment option for Stroke
Official title RESPARK - Brain Q for Chronic Stroke
ClinicalTrials.gov ID: NCT07095920
What this study is testing
- What it's testing
- This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
- Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
- Age 18 to 80 years of age (inclusive).
- Stroke due to ischemia or to intracerebral hemorrhage.
- \>6 months to 5 years from stroke onset.
You likely can't join if
- Severe neglect impairment interfering with assessments or treatments.
- Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15
- Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or...
- Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the...
- Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
- Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
See the full eligibility criteria
- Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
- Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
- Age 18 to 80 years of age (inclusive).
- Stroke due to ischemia or to intracerebral hemorrhage.
- \>6 months to 5 years from stroke onset.
- Box \& Block Test score with affected arm is ≥1 block in 60 seconds.
- 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 that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.
- If female, not pregnant or breastfeeding or planning pregnancy during the study period.
- The subject is able to provide Informed consent.
- Severe neglect impairment interfering with assessments or treatments.
- Severe depression, defined as Geriatric Depression Scale (GDS) Score \>10/15
- Presence of implanted or retained MR-incompatible devices or materials, 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 upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
- Pre-existing neurological condition (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the...
- 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...
- Unstable serious illness/condition (e.g., 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 trial that would conflict with the current study or clinical endpoint interference may occur.
- Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.
- Employee of the Sponsor.
- Prisoner.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.