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Clinical observational study of deep brain stimulation for Parkinson's disease

Clinical observational study of deep brain stimulation for Parkinson's disease

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092122
Enrollment
Unknown
Registered
2024-11-11
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Parkinson's disease

Interventions

Test group (surgical group):deep brain stimulation
Control group (non-surgical group):Anti-PD-related drugs

Sponsors

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.It meets the western medicine diagnostic criteria of primary Parkinson's disease. 2. Age is from 40 to 75 years old. 3.The course of the disease was more than 5 years, he had been treated with levodopa drugs and had good efficacy, and the improvement rate of dopamine shock test symptoms was 30%. 4.Hoehn-Yahr Parkinson's disease classification standard stage 2.5-4 5.The efficacy of drug treatment was significantly decreased, and intolerable exercise complications and drug side effects appeared. 6.The patient or the patient's legal representative was informed and agreed to perform the DBS surgery. 7.It meets the diagnostic criteria of geriatric fibrillation syndrome in the Diagnosis and Efficacy Evaluation Index of Traditional Chinese Medicine.

Exclusion criteria

Exclusion criteria: 1.Various secondary Parkinson's syndrome, familial inherited Parkinson's syndrome, and Parkinson's superposition syndrome. 2.Patients with other serious neurological diseases, loss of consciousness, dementia (simple intelligent state examination (MMSE) 24 points), mental disorders and other patients unable to communicate; 3.Having the serious underlying disease who cannot tolerate the operation or affect the postoperative survival period; 4.Failure to comply with the trial schedule.

Design outcomes

Primary

MeasureTime frame
International Movement Disorders Association Unified Parkinson's Disease Rating Scale Part III;

Secondary

MeasureTime frame
Equivalent levodopa drug dosage;DBS setup parameter;SCOUP-AUT;Parkinson’s Disease Questionnaire - 39;Local Field Potential,LFP;Gait monitoring;International Movement Disorders Association Unified Parkinson's Disease Rating Scale Part IV;Purdue nail board;HAMD;Hamilton Depression Scale,HAMD;Parkinson’s Disease Sleep Scale;

Countries

China

Contacts

Public ContactJun Li

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

18788899919@163.com+86 187 8889 9919

Outcome results

None listed

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