Deep Brain Stimulation of the Posterior Subthalamic Area (PSA) Versus Subthalamic Nucleus (STN) for Tremor-dominant Parkinson's Disease: a Prospective, Randomized, Double-blinded, Cross-over Trial

Trial ID: NCT05382858

Interventional - Phase Unknown - Completed

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) for the treatment of tremor-dominant Parkinson's disease (PD) in a randomized, double-blinded, cross-over manner.

Conditions

• Parkinson Disease

Interventions

• Deep brain stimulation

Eligibility

Inclusion criteria

• diagnosis of idiopathic Parkinson's disease
• tremor-dominant subtype in the on-medication condition
• modified Hoehn-Yahr scale of 2 to 4 in the on-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

Sponsor

Ruijin Hospital, Suzhou Sceneray Medical Co. , Ltd

Source: ClinicalTrials.gov

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