Subthalamic Nucleus Versus Globus Pallidal Internus Deep Brain Stimulation for Parkinson Disease

NCT07250685 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2025009
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 8

Brief Summary

The primary objective of this prospective, multicenter, double-blind, randomized, crossover clinical trial is to evaluate whether Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) is more effective than Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) in improving motor symptoms of patients with Parkinson's disease at 90 days post-treatment.

Conditions

PD - Parkinson's Disease

Keywords

Parkinson's disease(PD); Deep Brain Stimulation(DBS); Subthalamic Nucleus(STN); Globus Pallidus Internus(GPi)

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score

  The differences in UPDRS III scores obtained under the stimulation state at 90 days (±7 days) after surgery, compared with the preoperative scores, in patients with Parkinson's disease who received Subthalamic Nucleus-Deep Brain Stimulation (STN-DBS) or Globus Pallidus Internus-Deep Brain Stimulation (GPi-DBS) treatment. Doctors conducted double-blind evaluations based on this scoring scale. The Unified Parkinson's Disease Rating Scale Part III (UPDRS III) has a scoring range of 0 to 108 points, with higher scores indicating more severe motor symptoms in patients with Parkinson's disease.

  Before surgery and 90 days (±7 days) after surgery

Secondary Outcomes (11)

• Freezing of Gait Questionnaire (FOG-Q) score

  Before surgery and 90 days (±7 days) after surgery

• Berg Balance Scale (BBS) score

  Before surgery and 90 days (±7 days) after surgery

• Unified Dyskinesia Rating Scale (UDysRS) score

  Before surgery and 90 days (±7 days) after surgery

• Mini-Mental State Examination (MMSE) score

  Before surgery and 90 days (±7 days) after surgery

• Montreal Cognitive Assessment (MoCA) score

  Before surgery and 90 days (±7 days) after surgery

Study Arms (2)

First STN-DBS group

EXPERIMENTAL

Treatment involves deep brain electrode implantation with the STN target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the STN target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the GPi target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to GPi target therapy 90 days after receiving STN target stimulation.

Device: STN-DBS stimulation; Device: GPi-DBS stimulation; Device: STN&GPi-DBS stimulation

First GPi-DBS group

ACTIVE COMPARATOR

Treatment involves deep brain electrode implantation with the GPi target stimulation protocol.Stimulator activation time: To avoid the impact of local cerebral edema and microlesional effects after electrode implantation on clinical efficacy assessment, the GPi target stimulator will be activated at the first follow-up visit.Postoperative medication: During the study period, patients are not prohibited from using drug therapy. Existing therapeutic drugs may be adjusted or new drugs for Parkinson's disease may be added.At the second follow-up visit, patients will receive the STN target stimulation protocol.At the third follow-up visit, patients will receive the simultaneous STN + GPi stimulation protocol.At the final follow-up visit, the most clinically satisfactory stimulation protocol will be selected based on the patient's specific condition.Washout period: All patients will switch to STN target therapy 90 days after receiving GPi target stimulation.

Device: STN-DBS stimulation; Device: GPi-DBS stimulation; Device: STN&GPi-DBS stimulation

Interventions

STN-DBS stimulation DEVICE

The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). Participants will receive the STN target stimulation protocol for a 3-month treatment period.

First GPi-DBS group; First STN-DBS group

GPi-DBS stimulation DEVICE

The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). Participants will receive the GPi target stimulation protocol for a 3-month treatment period.

First GPi-DBS group; First STN-DBS group

STN&GPi-DBS stimulation DEVICE

The devices for this study are provided by Boston Scientific International Medical Trading (Shanghai) Co., Ltd.The system consists of two components: electrodes and an implanted stimulator.Participants will be implanted with an 8-contact directional electrode (Model: DB-2202-45).The stimulator is a rechargeable model (Model: DB-1232). After participants receive 3 months of STN target monotherapy and 3 months of GPi target monotherapy sequentially, they will be administered the combined STN + GPi target stimulation protocol. Prior to the initiation of simultaneous STN + GPi stimulation, participants are required to turn off the stimulator for 4 hours to eliminate the residual effects of the previous target stimulation.

First GPi-DBS group; First STN-DBS group

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: 22-75 years.
• Diagnosis of bilateral idiopathic PD with the presence of at least 2 of the following: resting tremor, rigidity, or bradykinesia
• Duration of idiopathic PD: ≥ 5 years.
• Severity of PD in the meds off condition: Hoehn-Yahr stages 2.5\~ 4.0.
• Despite optimal medication treatment, there are still persistent symptoms or drug side effects of disabling Parkinson's
• Must have tried a form of carbidopa/levodopa and/or one of the dopamine agonists as part of medication therapy.
• Anti-parkinsonian medications must improve PD symptoms by ≥33%, as measured by UPDRS-III score.
• UPDRS-III score of ≥ 30 in the meds off condition.
• The MMSE assessment was higher than the demarcation score of the corresponding educational level, and the cognitive function was normal.
• HAMD score≤24.
• No change in antidepressant medications utilized for treatment of depression for at least 8 weeks prior to informed consent.
• Stable on anti-parkinsonian medication for 28 days prior to informed consent.
• Could tolerate bilateral STN DBS and bilateral GPi DBS.
• 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
• Able to understand the study requirements and the treatment procedures and provides written informed consent before any studyspecific tests or procedures are performed.

You may not qualify if:

• Any intracranial abnormalities or medical conditions that Lead to the prohibition of DBS surgery.
• 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).
• HAMD score\>24.
• Any current drug or alcohol abuse, per DSM-IV criteria
• Any history of recurrent or unprovoked seizures.
• Any history of hemorrhagic stroke.
• Any previous treatment for movement disorders involving intracranial surgery or device implantation.
• 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
• Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
• Any previously implanted Vagus Nerve Stimulation (VNS) patients.
• Any previous brain surgery that would interfere with the placement of the leads or the functioning of the device.
• A condition requiring or likely to require the use of Magnetic Resonance Imaging (MRI), diathermy or electroconvulsive therapy (ECT)
• 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.
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
• Currently exhibiting secondary Parkinsonism due to prescribed medications.

Sponsors & Collaborators

• Zhang Jianguo: lead

Study Sites (8)

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

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

Wuhan, Hubei, 430030, China

Location

Nanjing Brain Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, 200120, China

Location

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, 300350, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (9)

• Sidiropoulos C, LeWitt PA, Odekerken VJ, Schuurman PR, de Bie RM. GPi vs STN deep brain stimulation for Parkinson disease: Three-year follow-up. Neurology. 2016 Aug 16;87(7):745-6. doi: 10.1212/WNL.0000000000003027. No abstract available.

  PMID: 27527541 RESULT

• Xu H, Zheng F, Krischek B, Ding W, Xiong C, Wang X, Niu C. Subthalamic nucleus and globus pallidus internus stimulation for the treatment of Parkinson's disease: A systematic review. J Int Med Res. 2017 Oct;45(5):1602-1612. doi: 10.1177/0300060517708102. Epub 2017 Jul 12.

  PMID: 28701061 RESULT

• Dulski J, Schinwelski M, Konkel A, Grabowski K, Libionka W, Waz P, Sitek EJ, Slawek J. The impact of subthalamic deep brain stimulation on sleep and other non-motor symptoms in Parkinson's disease. Parkinsonism Relat Disord. 2019 Jul;64:138-144. doi: 10.1016/j.parkreldis.2019.04.001. Epub 2019 Apr 5.

  PMID: 30975618 RESULT

• Ramirez-Zamora A, Ostrem JL. Globus Pallidus Interna or Subthalamic Nucleus Deep Brain Stimulation for Parkinson Disease: A Review. JAMA Neurol. 2018 Mar 1;75(3):367-372. doi: 10.1001/jamaneurol.2017.4321.

  PMID: 29356826 RESULT

• Okun MS. Deep-brain stimulation--entering the era of human neural-network modulation. N Engl J Med. 2014 Oct 9;371(15):1369-73. doi: 10.1056/NEJMp1408779. Epub 2014 Sep 8. No abstract available.

  PMID: 25197963 RESULT

• Chen J, Liu JL, Chen X, Qian H, Xian WB, Zhou HY, Liu YM, Ye XF, Zheng YF, Zhang SL, Chen L, Li JR, Liu ZL, Pei Z. [Significant improvement of motor symptoms by deep brain stimulation of bilateral subthalamic nucleus in patients with moderate or advanced Parkinson's disease]. Zhonghua Yi Xue Za Zhi. 2011 Feb 1;91(5):291-5. Chinese.

  PMID: 21419000 RESULT

• Nova IC, Perracini MR, Ferraz HB. Levodopa effect upon functional balance of Parkinson's disease patients. Parkinsonism Relat Disord. 2004 Oct;10(7):411-5. doi: 10.1016/j.parkreldis.2004.04.004.

  PMID: 15465397 RESULT

• Bejjani BP, Gervais D, Arnulf I, Papadopoulos S, Demeret S, Bonnet AM, Cornu P, Damier P, Agid Y. Axial parkinsonian symptoms can be improved: the role of levodopa and bilateral subthalamic stimulation. J Neurol Neurosurg Psychiatry. 2000 May;68(5):595-600. doi: 10.1136/jnnp.68.5.595.

  PMID: 10766889 RESULT

• Ma CL, Su L, Xie JJ, Long JX, Wu P, Gu L. The prevalence and incidence of Parkinson's disease in China: a systematic review and meta-analysis. J Neural Transm (Vienna). 2014 Feb;121(2):123-34. doi: 10.1007/s00702-013-1092-z. Epub 2013 Sep 22.

  PMID: 24057652 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Rujin Wang

CONTACT

+8618101287707; reganwang1223@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of the Neurosurgery Center,Director of the Functional Neurosurgery Ward,Director of the Neural Function Laboratory

Model Details: prospective, multicenter, superiority, double-blind, randomized crossover control.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 26, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)