Study of Traditional Chinese Medicine syndrome evolution of Parkinson's disease during deep brain stimulation

Study of syndrome evolution of Parkinson's disease during deep brain stimulation and Chinese traditional medicine treatment based on syndrome differentiation

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2000031915

Enrollment

Unknown

Registered

2020-04-14

Start date

2020-05-01

Completion date

Unknown

Last updated

2020-04-20

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

Conditions

Parkinson's disease

Interventions

case series:N/A

Eligibility

Sex/Gender

All

Age

45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 45 to 75 years old, patients with primary Parkinson's disease and DBS surgery; (2) The course of Parkinson's disease is 5 years or more; (3) The Hoehn-Yahr (H-Y) staging is 2 or more in the "off" (no medication) state; (4) UPDRS exercise score >= 30 in the "off" state; (5) The response to dopamine drugs is good, and the improvement rate of the UPDRS exercise score in the acute levodopa test is greater than 30% (the experimental drug Medopa 250mg); (6) The daily drug off period is at least 6 hours, or there are movement complications such as severe dyskinesia, and repeated adjustment of the drug still cannot effectively improve; (7) The MMSE score >= 24 points.

Exclusion criteria

Exclusion criteria: (1) Have received surgical treatment of Parkinson's disease other than deep brain stimulation, such as stereotactic lesions, cell transplantation, gamma knife, etc.; (2) The "off" state has serious middle-line symptoms such as language barriers, dysphagia, and balance disorders; (3) There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, brain atrophy, ventricular enlargement, cerebrovascular disease sequelae, and heart disease, severe platelet reduction and other cardiovascular and cerebrovascular diseases; (4) There are other concomitant diseases that have or need to be implanted with cardiac pacemakers, defibrillators, cochlear implants, and other nerve stimulators; (5) There are concomitant diseases such as tumors, severe abnormalities of liver function and kidney function (the index exceeds three times the normal value), which seriously affects health.

Design outcomes

Primary

Measure	Time frame
MDS-UPDRS-III;PDQ-39;TCM syndrome evaluation scale;	—

Countries

China

Contacts

Public ContactYu Ma

Medical College of Tsinghua University, Yuquan Hospital of Tsinghua University

mayu@tsinghua.edu.cn+86 13501085569

Outcome results

None listed

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