An interventional study of directional Deep brain stimulation in Parkinsons Disease (PD), sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 32 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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Exclusion Criteria:
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.
Device: directional Deep brain stimulation
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.
Device: directional Deep brain stimulation
active directional DBS with optimal stimulating parameters
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.
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
Change from Baseline in Fahn-Tolosa-Marin Clinical Rating Scale Between PSA and STN Stimulation in the chronic randomized phase
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 2 months after sugery
Adverse events
Time frame: Up to 12 months after surgery
Change from Baseline in Beck Depression Inventory-II Between PSA and STN Stimulation in the chronic randomized phase
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (pre-operation, OFF-medication) and the end of each 2-month stimulation period (Month 4 and Month 6)
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