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Randomized controlled trial of unilateral/bilateral DBS for the treatment of hemispheric Parkinson's disease

Randomized controlled trial of unilateral/bilateral DBS for the treatment of hemispheric Parkinson's disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066488
Enrollment
Unknown
Registered
2022-12-07
Start date
2022-12-07
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Parkinson's disease

Interventions

Intervention Group:Unilateral implanted deep brain stimulation
Intervention Group :Bilateral implanted deep brain stimulation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects and their relatives should give written informed consent to the study prior to initiating any procedure related to the study. 2)Age 18-75 years, not limited by sex; 3) diagnosis of primary PD; 4) right-handedness; 5) greater than Five years or more with predominantly tremor and difficulty in drug control (>4 years); 6) excellent response to L-dopa in combination. Currently unable to satisfactorily control symptoms, severe motor complications, or difficulty to tolerate after adequate medical treatment. Medical adverse events; 7) Improvement in motor scores of more than 30% in the MedDRA trial; 8) Left- and right-sided dyskinesias. Differences in MDS-UPDRS III scores greater than 30% (found in a small sample of 8 patients, right and left side symptoms 9) Grades of H-Y grades 2-3, and 10) Patients were well informed of their willingness to treat unilaterally. Full cooperation with study protocols can be coordinated with investigations, follow-up, and associated protocols to fulfill study requirements.

Exclusion criteria

Exclusion criteria: 1) Subjects did not meet the diagnostic criteria for PD; 2) Severe personality disorder, cognitive impairment; 3) Subjects with contraindications to surgery, such as major medical comorbidities or inability to stop anticoagulation; 4) any structural abnormalities on preoperative MRI of the head; 5) contraindications to MRI examination (except for DBS implants or stimulators themselves); 6) pregnancy; 7) subjects who were unable to comply with the tests and follow-up required for completion of the study were enrolled in another study not related to the current study.

Design outcomes

Primary

MeasureTime frame
UPDRS-III motor score;

Secondary

MeasureTime frame
Local Filed Potential;Structural Analysis of MRI;PD-related drugs. Drug Adjustment;

Countries

China

Contacts

Public ContactWei Wang

West China Hospital of Sichuan University

wcnsww@163.com+86 18980601521

Outcome results

None listed

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