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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.
This single-center trial utilizes directional deep brain stimulation (DBS) current-steering technology to compare the clinical efficacy and tolerability of the posterior subthalamic area (PSA) versus the subthalamic nucleus (STN) for the treatment of tremor-dominant Parkinson's disease (TD-PD) within the same subject. The study is optimized into a two-phase framework to maximize patient safety and protocol compliance:
Phase 1: Two-month post-implantation, acute mapping is conducted to define the therapeutic window for PSA and STN configurations in a blinded randomized order. If a configuration induces immediate, unmanageable adverse events before reaching efficacy, it is classified as "intolerant" and excluded from that participant's subsequent chronic phase.
Phase 2 (Chronic Crossover): Participants with tolerated configurations are entered into a chronic randomized phase with a blinded sequence of 2-month PSA or STN chronic stimulation. Following the core two-arm crossover, all eligible patients transition into an open-label, exploratory sequential add-on phase of 2-month with combined PSA+STN stimulation to evaluate potential synergistic benefits.
All participants will then be followed-up up to 12 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| directional PSA-STN | Experimental | Participants randomized in this arm will receive the bilateral directional PSA stimulation and then will be crossovered to the bilateral directional STN stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional PSA stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional STN stimulation for another two months. |
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| directional STN-PSA | Experimental | Participants randomized in this arm will receive the bilateral directional STN stimulation and then will be crossovered to the bilateral directional PSA stimulation in the acute mapping phase (phase I). After that, participants will receive the bilateral directional STN stimulation in the first two months in the chronic randomized phase (phase II) and then will be crossovered to the bilateral directional PSA stimulation for another two months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| directional Deep brain stimulation | Device | active directional DBS with optimal stimulating parameters |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale 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) | |
| Change from Baseline in Movement Disorder Society-sponsord Unified Parkinson's Disease Rating Scale Part III total score Between PSA and STN Stimulation in the chronic randomized phase |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Beck Depression Inventory-II 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) | |
| Change from Baseline in Beck Anxiety Inventory Between PSA and STN Stimulation in the chronic randomized phase |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianyou Li, MD, PhD | Contact | +0086-021-64370045 | ldy11483@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6) |
| Change from Baseline in Berg Balance Scale score 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) |
| Change from Baseline in 39-item Parkinsons disease questionnaire Between PSA and STN Stimulation in the chronic randomized phase | Baseline (pre-operation) and the end of each 2-month stimulation period (Month 4 and Month 6) |
| Proportion of Participants with Acute Phase Intolerance to Single-Target Stimulation | Up to 2 months after sugery |
| Adverse events | Up to 12 months after surgery |
| Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6) |
| Change from Baseline in nonmotor symptoms scale for Parkinson's disease (NMSS) 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) |
| Change from Baseline in Mini-Mental State Examination 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) |
| Change from Baseline in levodopa equivalent daily dose 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) |
| Change from Baseline in total electrical energy delivered 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) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |