BCIwiki (bciwiki.com) — A study on the safety and efficacy of a brain-computer interface combined with functional electrical stimulation in Parkinson's disease has been registered with the Chinese Clinical Trial Registry (ChiCTR) under registration number ChiCTR2600124148, dated May 8, 2026. The sponsor is Binzhou Medical University Hospital. The study is an interventional, parallel-design trial conducted in China; recruitment has not yet started, and the first enrolment date is May 12, 2026.
The trial plans to enroll 40 patients with Parkinson's disease aged 40 to 80, both sexes, with 20 in the treatment group and 20 in the control group. The treatment group receives brain-computer interface training equipment (written in the registry as the LSR-A BCI Rehabilitation Training System) in addition to functional electrical stimulation therapy; the control group receives functional electrical stimulation therapy alone. Both arms train 20 minutes per day for the upper extremities and 20 minutes per day for the lower extremities, completing 12 treatment days within 2 weeks.
The primary outcome is the MDS Unified Parkinson's Disease Rating Scale. Secondary outcomes include fractional anisotropy and mean diffusivity on diffusion tensor imaging, glutamate, diffusion tensor imaging analysis along the perivascular space, amplitude of low-frequency fluctuation and regional homogeneity, the Non-Motor Symptoms Scale for Parkinson's Disease, the Pittsburgh Sleep Quality Index, the Hoehn-Yahr stage, the Montreal Cognitive Assessment, the Parkinson's Disease Questionnaire-39, the Parkinson's Disease Sleep Scale-2, the Hamilton Anxiety Rating Scale, the Hamilton Depression Rating Scale-17, the Fatigue Scale-14, the Autonomic Nervous System Symptom Self-Rating Scale, and the Patient Assessment of Constipation-Symptoms.
Inclusion criteria require a diagnosis of Parkinson's disease per the 2015 criteria of the United Kingdom Parkinson's Disease Society Brain Bank and the Movement Disorder Society, and stable use of levodopa and benserazide tablets, dopamine receptor agonists, or monoamine oxidase type B inhibitors for one month before enrollment. Exclusion criteria include secondary parkinsonian syndromes, Parkinson-plus syndromes and other non-primary Parkinson's disease; intracranial metal implants, cardiac pacemakers or an incomplete skull; skin lesions, damage, infection or electrode allergy at the electrode contact sites; a history of stroke or thrombosis within one year; and severe cognitive impairment or comorbid serious mental disorders that would prevent adherence to the protocol.
Funding is self-funded. The registry record was last updated on May 11, 2026. The registration page contains only bibliographic and design fields, with no results data; the specific device model and actual enrollment numbers are not listed.