Study for Syndrome Differentiation of Traditional Chinese Medicine in the Treatment of Parkinson's Disease With Deep Brain Stimulation: a Randomized Controlled Tiral

Phase 1

• Conditions: Parkinson's disease

• Registration Number: ITMCTR2000003209
• Lead Sponsor: Yuquan Hospital of Tsinghua University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Patients aged 45-75 years old with primary Parkinson's disease after DBS;
2. Patients whose course of Parkinson's disease is 5 years or more;
3. Hoehn Yahr (H-Y) was divided into two or more stages under the condition of off (not taking medicine);
4. UPDRS score >= 30 in off state;
5. The patients who respond well to dopamine drugs and improved the UPDRS score of acute levodopa test more than 30% (medoba 250mg);
6. Patients whose daily drug clearance period is at least 6 hours, or who have serious movement complications such as abnormal movement, and who can not be effectively improved by repeated adjustment of drugs;
7. Patients with MMSE score >= 24.

Exclusion Criteria

1. Patients who have received surgery for Parkinson's disease other than deep brain stimulation, such as stereotactic lesion, cell transplantation, gamma knife, etc.;
2. Off state has severe middle line symptoms such as language disorder, dysphagia and balance disorder;
3. There are contraindications of Neurosurgery, such as cerebral infarction, hydrocephalus, brain atrophy, ventricular enlargement, sequelae of cerebrovascular disease, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases;
4. Patients with other concomitant diseases who have or need to be implanted with pacemakers, defibrillators, cochlear implants and other nerve stimulators;
5. Patients with tumor, serious abnormality of liver function and kidney function (index more than three times of normal value) and other concomitant diseases that seriously affect health.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TCM syndrome curative effect index;PDQ-39;MDS-UPDRS-III;