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NCT07858006
Brain-computer Interface (BCI)-Guided Upper Limb Neurorehabilitation for Acute Stroke With the recoveriX System
Conditions: Stroke
Sex: All
Ages: 21 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 12
Sponsor: Tan Tock Seng Hospital
Summary
Stroke is a leading cause of neurological disability and upper limb impairment. While conventional rehabilitation options exist, brain-computer interface (BCI)-based neurorehabilitation has emerged as a promising approach that records and decodes neural signals to drive rehabilitation devices or functional electrical stimulation. By re-coupling cortical motor intent to limb movement, BCI systems restore closed-loop neurofeedback and facilitate neuroplasticity through residual neural pathways. Motor intent is detected non-invasively via scalp electroencephalography (EEG), using characteristic changes in mu and beta rhythm activity known as event-related desynchronisation (ERD). This study aims to investigate how these electrophysiological signals change over time following stroke and their implications for BCI-based rehabilitation.
Eligibility Criteria
Inclusion Criteria:
* Adults between age 21 to 80 years with hemorrhagic or ischemic stroke
* Stroke onset within 2-12 weeks
* Any demonstrated voluntary finger flexion or finger extension Oxford Medical Research Council (MRC) grade 0 to 4 (total 5)
* Montreal Cognitive Assessment (MoCA) \> 20
* Ability to understand written and spoken instructions, as well as stable medical and neurological status.
Exclusion Criteria:
* Presence of previous diagnosis of stroke
* Implanted pacemaker or continuous infusion pump
* History of seizures or past history of epilepsy
* Recent neurosurgery
* Medical instability deemed by study team
* Severe blindness
* Anticipated life expectancy \4/10) or severe hemi anesthesia or spasticity in the paretic arm (modified Ashworth scale MAS \>2, total 4)
* Fixed shoulder or finger joint contractures, active arthritis in any upper limb joint
* Inability to tolerate upright supported sitting posture for at least 45 minutes
* Disorders of consciousness or altered arousal states precluding active participation in the task.
* Pregnant women will be excluded from the study as the safety of FES (electrical stimulations) on foetus is unclear.
Source: ClinicalTrials.gov (NCT07858006). StuddyBuddy aggregates publicly available trial information.