Clinical trial NCT05382858: PSA Versus STN DBS for TD-PD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: tremor-dominant Parkinson's disease
deep brain stimulation
posterior subthalamic area
subthalamic nucleus
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Suzhou Sceneray Medical Co. , Ltd
First posted: 2022-05-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: This is a randomized, double-blinded, crossover trial aiming at comparing the efficacy of PSA and STN DBS in treating tremor-dominant PD. Enrolled patients will undergo bilateral DBS surgery, targeting both PSA and STN with single trajectory. Two months post-implantation, patients enter a 4-month double-blinded crossover phase with PSA and STN DBS in randomized order. After 6 months post-implantation (at the end of the crossover phase), patients enter an open-label phase during which programming parameters are not restricted until the termination of the study at 12-month follow-up.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 4 months
timeFrame: 4 months
measure: Change from baseline Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 4 months
timeFrame: 4 months
measure: Change from baseline Fahn-Tolosa-Marin Clinical Rating Scale for Tremor to 6 months
timeFrame: 6 months
measure: Change from baseline Timed up and go test to 4 months
timeFrame: 4 months
measure: Change from baseline Timed up and go test to 6 months
timeFrame: 6 months
measure: Change from baseline Berg balance scale to 4 months
timeFrame: 4 months
measure: Change from baseline Berg balance scale to 6 months
timeFrame: 6 months
measure: Change from baseline 39-item Parkinsons disease questionnaire to 4 months
timeFrame: 4 months
measure: Change from baseline 39-item Parkinsons disease questionnaire to 6 months
timeFrame: 6 months
measure: Change from baseline Levodopa equivalent daily dose to 4 months
timeFrame: 4 months
measure: Change from baseline Levodopa equivalent daily dose to 6 months
timeFrame: 6 months
measure: Change from baseline maximal phonatory time to 4 months
timeFrame: 4 months
measure: Change from baseline maximal phonatory time to 6 months
timeFrame: 6 months
measure: Change from baseline dysphonia severity index to 4 months
timeFrame: 4 months
measure: Change from baseline dysphonia severity index to 6 months
timeFrame: 6 months
measure: Change from baseline Mini-Mental Status Exam to 4 months
timeFrame: 4 months
measure: Change from baseline Mini-Mental Status Exam to 6 months
timeFrame: 6 months
measure: Change from baseline Beck depression inventory to 4 months
timeFrame: 4 months
measure: Change from baseline Beck depression inventory to 6 months
timeFrame: 6 months
measure: Adverse events
timeFrame: up to 12 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Dianyou Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: