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Electrophysiological study on deep brain stimulation regulating rapid eye movement sleep disorder in Parkinson's disease

Electrophysiological study on deep brain stimulation regulating rapid eye movement sleep disorder in Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071718
Enrollment
Unknown
Registered
2023-05-23
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

STN-DBS HFS:High frequency STN-DBS
STN-DBS LFS:Low frequency STN-DBS
GPi-DBS HFS:High frequency GPi-DBS
GPi-DBS LFS:Low frequency GPi-DBS

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. PD patients diagnosed according to British Brain Bank standards who were hospitalized in the functional neurosurgery department of Tiantan Hospital for DBS surgery; 2. Preoperative diagnosis of clinical RBD based on the Rapid Eye Movement Sleep Disorder Screening Scale (score >= 5); 3. Aged 35-70 years old; 4. Perform bilateral STN-DBS surgery or bilateral GPi-DBS surgery; 5. There were no serious adverse reactions such as intracranial hemorrhage or infection during the perioperative period.

Exclusion criteria

Exclusion criteria: 1. Having serious mental, cognitive, and psychological disorders, unable to sign informed consent forms, or unable to cooperate with surgeries and various tasks; 2. There are contraindications to neurosurgery, such as hydrocephalus, brain atrophy, sequelae of cerebrovascular disease, heart disease and other cardiovascular and cerebrovascular diseases; 3. There are accompanying diseases that seriously affect health, such as tumors and severe abnormalities in liver and kidney function (indicators exceeding three times the normal value); 4. Fear of claustrophobia, presence of implants in the body, affecting magnetic resonance imaging; 5. The preoperative evaluation showed that MMSE < 22 or MoCA < 15, indicating the presence of severe dementia in PD patients.

Design outcomes

Primary

MeasureTime frame
Beta power in EEG;Unified Parkinson's Disease Rating Scale (UPDRS);Quality of life score (QOL);Pittsburgh sleep quality score (PSQI);Parkinson's disease unified sleep quality score (PDSS);Rapid eye movement sleep disorder screening scale (RBDSQ);Evaluation of cognitive function;Montreal Cognitive Assessment (MoCA);Mini-mental state examination;Hamilton Depression Rating Scale (HAMD);Hamilton Anxiety Scale (HAMA);—

Countries

China

Contacts

Public ContactYang Anchao

Beijing Tiantan Hospital

yang.anchao@163.com+86 188 1058 8671

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026