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Brain pacemaker showdown: which target best eases Parkinson's symptoms?

NCT ID NCT07250685

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two brain areas for deep brain stimulation (DBS) in 86 people with Parkinson's disease. The goal is to see which target—the subthalamic nucleus (STN) or the globus pallidus internus (GPi)—better improves movement symptoms 90 days after surgery. Participants will be randomly assigned to one target and then switch to the other, with doctors and patients unaware of which is active.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 86 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age at the time of enrollment: 22-75 years. 2. Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia 3. Duration of idiopathic PD: ≥ 5 years. 4. Severity of PD in the meds off condition: Hoehn-Yahr stages 2.5\~ 4.0. 5. Despite optimal medication treatment, there are still persistent symptoms or drug side effects of disabling Parkinson's 6. Must have tried a form of carbidopa/levodopa and/or one of the dopamine agonists as part of medication therapy. 7. Anti-parkinsonian medications must improve PD symptoms by ≥33%, as measured by UPDRS-III score. 8. UPDRS-III score of ≥ 30 in the meds off condition. 9. The MMSE assessment was higher than the demarcation score of the corresponding educational level, and the cognitive function was normal. 10. HAMD score≤24. 11. No change in antidepressant medications utilized for treatment of depression for at least 8 weeks prior to informed consent. 12. Stable on anti-parkinsonian medication for 28 days prior to informed consent. 13. Could tolerate bilateral STN DBS and bilateral GPi DBS. 14. Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system and completing the PD Diary 15. Able to understand the study requirements and the treatment procedures and provides written informed consent before any studyspecific tests or procedures are performed. Exclusion Criteria: 1. Any intracranial abnormalities or medical conditions that Lead to the prohibition of DBS surgery. 2. Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders). 3. HAMD score\>24. 4. Any current drug or alcohol abuse, per DSM-IV criteria 5. Any history of recurrent or unprovoked seizures. 6. Any history of hemorrhagic stroke. 7. Any previous treatment for movement disorders involving intracranial surgery or device implantation. 8. Any other active implanted devices including neurostimulators (e.g., cochlear implant, pacemaker) and /or drug delivery pumps, whether turned on or off. Passive implants (e.g., knee prostheses) would be allowed provided that they do not interfere with the functioning of the DBS system 9. Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure. 10. Any previously implanted Vagus Nerve Stimulation (VNS) patients. 11. Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device. 12. A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT) 13. Likely to require the use of monopolar cau Likely to require the use of monopolar cautery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation.tery, radiofrequency (RF) procedures, external defibrillation, lithotripsy, radiation therapy or transcranial stimulation. 14. Currently on any anticoagulant medications that cannot be discontinued during perioperative period. 15. Currently exhibiting secondary Parkinsonism due to prescribed medications. 16. Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. 17. Any terminal illness with life expectancy of \< 1 year. 18. Any unresolved infection, a coagulopathy or significant cardiac or other medical risk factor for surgery 19. Current or future risk of being immunocompromised that might significantly increase risk of infection. 20. Participation in any other clinical trial (e.g. drug, device, or biologics) concurrently or within the preceding 30 days. Participation in any other study will be allowed per investigator/sponsor discretion only. 21. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception. 22. Preoperative DBS plan failed to implant STN and GPi. nuclei.(Usually limited by individual anatomical differences) 23. Preoperative CT scan of the head revealed calcification of the GPI.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100070, China

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality, 200120, China

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116011, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300350, China

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430030, China

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