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To investigate the mechanism of tremor during sleep-wake transition in Parkinson's disease based on intelligent sensing DBS

To investigate the mechanism of tremor during sleep-wake transition in Parkinson's disease based on intelligent sensing DBS

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106377
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Parkinson's disease

Interventions

Deep brain electrical stimulation group:Deep brain electrical stimulation

Sponsors

Jinan Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. clinical diagnosis of primary Parkinson's disease with clear surgical indications (according to the 2012 Chinese expert consensus on deep brain stimulation for Parkinson's disease); 2. positive preoperative levodopa challenge test; 3. patients with moderate to severe sleep disorders (PSQI >=10); 4. UPDRSIII tremor score >=2; 5. planned DBS surgery, and the intracranial electrodes were implanted at STN; 6. signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cognitive impairment (MMSE<24), inability to live independently, no self-care ability, and significant communication disorder; 2. patients with severe mental illness, such as depression, anxiety and schizophrenia, who are unable to follow up; 3. patients with other serious diseases and serious surgical complications, which seriously affect the effect of surgery, prognosis and quality of life.

Design outcomes

Primary

MeasureTime frame
Relative power of the ß band;High-frequency oscillation power;Phase-amplitude coupling strength;normalized root-mean-square value;Duration and proportion of each sleep stage;Awakening - Sleep Transition Event;EMG time-domain and frequency-domain features;The intensity index of limb tremors;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;Hamilton Anxiety Scale;Hamilton Depression Scale;Mini-Mental State Examination;UPDRS-III;

Countries

China

Contacts

Public ContactSu Daoqing

Jinan Central Hospital (Capital Medical University Xuanwu Hospital Jinan Hospital)

daoqingsu@163.com+86 195 8897 0697

Outcome results

None listed

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