Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059236) titled 'Assessing Functional Brain Reorganization after Brain-Machine Interface Rehabilitation for Hand Paresis in Subacute Stroke' on Sept. 30.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Hokuto Social Medical Corporation Tokachi Rehabilitation Center

Condition: Condition - stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to investigate whether a 2-week Brain-Machine Interface (BMI) training intervention induces changes in functional brain connectivity. To achieve this, we will acquire resting-state functional connectivity MRI (rs-fcMRI) scans before and after the training period. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - A 2-week, non-invasive Brain-Machine Interface (BMI) intervention.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 05 Month 28 Day Date of IRB - 2025 Year 06 Month 25 Day Anticipated trial start date - 2025 Year 05 Month 28 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067754

Disclaimer: Curated by HT Syndication.