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Research on Basal Ganglia-Cortical Electrophysiological Mechanisms of Deep Brain Stimulation in Regulating Sleep Disorders in Parkinson's Disease

Research on Basal Ganglia-Cortical Electrophysiological Mechanisms of Deep Brain Stimulation in Regulating Sleep Disorders in Parkinson's Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600126226
Enrollment
Unknown
Registered
2026-06-05
Start date
2026-06-30
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

Parkinson's disease

Interventions

External Stimulus Test Group:During the 3-7 day external test period in the same patient, polysomnography (PSG) is used to record local field potentials (LFP) in the frontoparietal cortex and STN duri
High-frequency stimulation group:Both during the day and at night, the subjects received the commonly used high-frequency stimulation (130Hz, 2.0mA, pulse width 60µs, monopolar stimulation), with the
Optimized stimulation group:This group received other optimal stimulation parameters for improving sleep during the night (such as 4Hz, 1.0mA, pulse width 60µs, monopolar stimulation). The stimulation

Sponsors

Beijing Tiantan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with Parkinson's disease (PD) who were hospitalized in the Functional Neurosurgery Department of Tian Tan Hospital and underwent DBS surgery according to the diagnostic criteria of the British Brain Bank; 2. With sleep disorders (such as difficulty falling asleep, abnormal movements at night, REM sleep behavior disorder, etc.); 3. Age 50-75 years old, with a disease duration of more than 5 years; 4. H-Y stage >= 2.0, MMSE score >= 24, good patient compliance, and able to cooperate with the requirements of postoperative follow-up; 5. Preoperative sleep assessment (such as PDSS-2, sleep disorder SQ, etc.) shows obvious sleep disorders. 6. Bilateral STN-DBS surgery was performed.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications for DBS surgery, such as severe cognitive impairment, mental illness, intracranial infection, etc.; 2. Patients with severe mental, cognitive, or psychological disorders who cannot sign the informed consent form or cannot cooperate with the surgery and various tasks; 3. Patients with contraindications for neurosurgery, such as hydrocephalus, brain atrophy, sequelae of cerebrovascular diseases, heart diseases and other cardiovascular and cerebrovascular diseases; 4. Patients with accompanying diseases that seriously affect health, such as tumors, severe abnormalities in liver and kidney functions (indicating values exceeding normal limits by three times); 5. Patients with claustrophobia or implanted objects in the body, which affect MRI scans; 6. Patients who cannot cooperate with postoperative follow-up or data collection.

Design outcomes

Primary

MeasureTime frame
Overall improvement rate of sleep quality;

Secondary

MeasureTime frame
Symptoms of REM sleep behavior disorder;Pittsburgh Sleep Quality Index;Polysomnogram;Cognitive function;Executive function;Emotional state;Behavioral assessment;

Countries

China

Contacts

Public ContactZhang Jianguo

Beijing Tiantan Hospital

zjguo73@126.com+86 136 0129 4613

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026