stroke
Conditions
Interventions
A 2-week, non-invasive Brain-Machine Interface (BMI) intervention.
Sponsors
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age: Patients must be 18 years of age or older. Diagnosis: Patients who present with upper limb paresis caused by a stroke. Severity of Paresis: A total score of 47 or less on the upper extremity motor section of the Fugl-Meyer Assessment (FMA) for the affected limb.
Exclusion criteria
Exclusion criteria: Joint Contracture: Patients with a passive extension range of motion of the metacarpophalangeal joints in the paretic hand of less than -10 degrees (i.e., a flexion contracture exceeding 10 degrees). Time Since Onset: Patients in the chronic phase, defined as 180 days or more since the onset of upper limb paresis. Cognitive Function: Patients who are unable to provide informed consent or have impaired decision-making capacity. Severe Comorbidities: Patients with severe, unstable medical conditions (e.g., malignancy) that may interfere with the study procedures or safety. Pregnancy and Lactation: Women who are pregnant, breastfeeding, or have the possibility of being pregnant. Implanted Electronic Devices: Patients with a cardiac pacemaker, implantable cardioverter-defibrillator, or other active implanted electronic devices. Implanted Magnetic/Metallic Materials: Patients with ferromagnetic materials in the body, such as intracranial aneurysm clips, surgical clips, cochlear implants, or artificial eyes. Tattoos and Permanent Makeup: Patients with extensive tattoos (particularly those containing metallic dyes) or permanent makeup (e.g., eyeliner, eyebrows) that may cause burns during MRI. Claustrophobia: Patients with a history of severe claustrophobia. Inability to Maintain Position: Patients who are unable to remain in a supine position for approximately 30 minutes. EEG Acquisition: Patients with scalp conditions or cranial deformities that would prevent the acquisition of a quality electroencephalogram (EEG). Participation in Other Trials: Patients who have previously participated in other investigational trials for upper limb paresis. Prior Antispasmodic Treatments: Patients who have previously received botulinum toxin therapy or nerve blocks (e.g., phenol block) for spasticity in the affected upper limb. Investigator's Discretion: Patients deemed unsuitable for participation in the study for any reason by the investigator or physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Measure: Resting-state functional connectivity MRI (rsfcMRI) Timepoint: Before and after the 2-week intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Stroke Impairment Assessment Set Modified Ashworth Scale Motor Activity Log Functional Independence Measure Range of Motion Electroencephalogram (EEG) | — |
Countries
Japan
Contacts
Public ContactRyosuke Takahashi
Hokuto Social Medical Corporation Tokachi Rehabilitation Center Physical Therapy Division, Department of Rehabilitation
Outcome results
None listed