Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

NCT04616521 | Not Yet Recruiting

• 1 other identifier: Ruijin_ADP
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.

Conditions

Parkinson Disease

Keywords

deep brain stimulation; subthalamic nucleus; globus pallidus interna; asymmetric deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)

  Score ranges from 0 to 132, higher scores mean a worse outcome.

  Followed for minimum of 7 years

Secondary Outcomes (16)

• Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV

  Followed for minimum of 7 years

• Time-Up-Go (TUG) task

  Followed for minimum of 7 years

• Berg Balance Scale, BBS

  Followed for minimum of 7 years

• Gait and Falls Questionnaire, GFQ

  Followed for minimum of 7 years

• Montreal Cognitive Assessment (MoCA)

  Followed for minimum of 7 years

Study Arms (1)

Asymmetric DBS group

EXPERIMENTAL

In this arm, a one-staged combined unilateral STN and contralateral GPi DBS will be implanted into PD patients. For postural instability and gait difficulty (PIGD)-dominant patients, the GPi in the side contralateral to the leg with longer step length will be targeted. For tremor-dominant (TD) patients, the STN in the side contralateral to the body side that mostly affected will be targeted. For PD patients of mixed type, the choice of target will depend on the judgement of a multidisciplinary team based on clinical features.

Procedure: Deep brain stimulation

Interventions

Deep brain stimulation PROCEDURE

The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.

Asymmetric DBS group

Eligibility Criteria

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

You may qualify if:

• Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
• Aged more than 18 years
• Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
• the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
• Compliance with written informed consent

You may not qualify if:

• Atypical parkinsonian syndrome
• 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 or that increases 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Huashan Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• West China Hospital: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• Tianjin Huanhu Hospital: collaborator
• Guangzhou General Hospital of Guangzhou Military Command: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator

MeSH Terms

Conditions

Parkinson Disease

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Dianyou Li, MD, PhD

CONTACT

13817864569; ldy11483@rjh.com.cn

Chencheng Zhang, MD, PhD

CONTACT

18217122884; i@cczhang.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Functional Neurosurgery, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 5, 2020
• Study Start: January 1, 2021
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2030
• Last Updated: December 24, 2020

Record last verified: 2020-12