directional Deep brain stimulation: active directional DBS with optimal stimulating parameters
Study summary
The aim of this study is to compare the effectiveness of the deep brain stimulation in the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) using directional lead for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* diagnosis of idiopathic Parkinson's disease
* tremor-dominant subtype in the off-medication condition
* modified Hoehn-Yahr scale of 2 to 4 in the off-medication condition
* receiving regular anti-parkinsonian drugs for more than 6 weeks
* good compliance and written informed consent provided
Exclusion Criteria:
* Atypical parkinsonism
* History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
* Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
* Presence of anatomical abnormalities in the target region
* Clinically significant medical history that would increase pre-/post-operative complications
* Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
Primary outcome measure(s)
Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III tremor subscore Between PSA and STN Stimulation in the chronic randomized phase — Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6) The tremor subscore is derived from the sum of items 3.15 to 3.18 of the MDS-UPDRS-III. This measure directly compares the within-subject efficacy of directional PSA stimulation versus directional STN stimulation in the chronic cross-over phase. Lower scores indicate greater tremor suppression.
Trial sites (1)
Facility
City
Region
Status
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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