Directional PSA vs STN DBS for tremor-dominant PD
Official title: Directional 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
Run by Ruijin Hospital · NCT07700862 · Data updated 2026-11-12
This study tests whether directional DBS targeting the PSA or the STN helps people with tremor-dominant Parkinson’s disease, using a blinded crossover design.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Ruijin Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | July 1, 2026 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07700862 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with idiopathic tremor-dominant PD, off-medication tremor with Hoehn-Yahr 2-4, and able to provide informed consent.
✕Probably not a fit
Patients not responding to DBS trials or with exclusionary brain pathology or comorbidities may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This trial compares two DBS targets, the posterior subthalamic area (PSA) and the subthalamic nucleus (STN), using directional leads in people with tremor-dominant PD. In phase one, researchers map the two targets after implantation to determine tolerable configurations in a blinded randomized order. Phase two uses a chronic, blinded crossover where participants receive PSA and STN stimulation in random sequences, followed by an open-label add-on phase to explore potential synergistic effects. All participants are followed for up to 12 months post-surgery to assess efficacy and tolerability.
Why it matters
Potential benefit: If successful, patients may experience better control of tremor and motor symptoms with tailored directional stimulation.
How similar studies have gone: Directional DBS approaches have shown promise in optimizing symptom control, though this exact PSA vs STN comparison with blinded crossover is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China Recruiting
Study contacts
- Study coordinator: Dianyou Li, MD, PhD
- Email: ldy11483@rjh.com.cn
- Phone: +0086-021-64370045
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.