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New treatment option for Stroke
Official title BCI-FES for Upper Limb Rehabilitation in Chronic Stroke
ClinicalTrials.gov ID: NCT06409754
What this study is testing
- What it's testing
- The objective of this research is to evaluate the efficacy of an experimental therapy for motor recovery of the arm after a stroke, which includes the application of a functional electrical stimulation therapy coupled to P-300 based Brain-Computer Interface system (BCI-FES). For this purpose, the investigators will compare two groups, the first one will receive only conventional physical therapy, while the second one will receive physical conventional therapy together with BCI-FES therapy.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
- ≥6 months from stroke onset, chronic phase
- Unilateral lesion
- Age ≥18 years
- Moderate-severe hemiparesis (FMA-UE: ≤45)
You likely can't join if
- Neurological disorders (Parkinsons disease, epilepsy, dementia)
- Neurological or musculoskeletal condition directly affecting the upper limb (dystonia, severe spasticity -muscle tone for elbow, wrist and fingers \>...
- Contraindications for MRI (implantable devices -pacemakers-, claustrophobia, others)
- Cognitive deficit (MoCA \<20 points)
- Severe aphasia
- Severe psychiatric disorders
See the full eligibility criteria
- Patients with ischemic or hemorrhagic stroke (evidenced by CT or MRI)
- ≥6 months from stroke onset, chronic phase
- Unilateral lesion
- Age ≥18 years
- Moderate-severe hemiparesis (FMA-UE: ≤45)
- Full passive ranges of motion in the elbow, forearm, wrist, and hand
- Minimal cognitive level necessary to follow instructions and complete tasks
- Desire to participate in the study
- Neurological disorders (Parkinsons disease, epilepsy, dementia)
- Neurological or musculoskeletal condition directly affecting the upper limb (dystonia, severe spasticity -muscle tone for elbow, wrist and fingers \> 3 according to modified Ashworth scale-)
- Contraindications for MRI (implantable devices -pacemakers-, claustrophobia, others)
- Cognitive deficit (MoCA \<20 points)
- Severe aphasia
- Severe psychiatric disorders
- More than one stroke
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. 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.