BridgeMD
New treatment option for Stroke
Official title Q Therapeutic System for Chronic Stroke Recovery
ClinicalTrials.gov ID: NCT06979466
What this study is testing
- What it's testing
- 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.
- 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
- 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.
You likely can't join if
- 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...
- 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 UE spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score≥3 in either biceps or pectoralis
See the full eligibility 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.
- 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...
- 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 (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 treatment 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...
- Employee of the Sponsor.
- Prisoner.
The study team makes the final eligibility decision.
Where it's taking place
- White Plains, New York, 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 White Plains, New York, 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.