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

Parkinson Disease Clinical Trial

— ADP  

Official title:

Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04616521
• Other study ID #: Ruijin_ADP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 30, 2030

Study information

• Verified date: December 2020
• Source: Ruijin Hospital
• Contact: Dianyou Li, MD, PhD
• Phone: 13817864569
• Email: ldy11483[@]rjh.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2030
• Est. primary completion date: November 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Procedure:
• Deep brain stimulation
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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

Ruijin Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV	Score ranges from 0 to 128, higher scores mean a worse outcome.	Followed for minimum of 7 years
Secondary	Time-Up-Go (TUG) task		Followed for minimum of 7 years
Secondary	Berg Balance Scale, BBS	Score ranges from 0 to 132, higher scores mean a better outcome.	Followed for minimum of 7 years
Secondary	Gait and Falls Questionnaire, GFQ	Score ranges from 0 to 64, higher scores mean a worse outcome.	Followed for minimum of 7 years
Secondary	Montreal Cognitive Assessment (MoCA)		Followed for minimum of 7 years
Secondary	Beck Depression Inventory, BDI		Followed for minimum of 7 years
Secondary	Beck Anxiety Inventory, BAI		Followed for minimum of 7 years
Secondary	Apathy Estimation Scale, AES		Followed for minimum of 7 years
Secondary	Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF	True-or-false questions screening the obsessive-compulsive behaviors in parkinson's disease	Followed for minimum of 7 years
Secondary	Epworth Sleepiness Scale, ESS		Followed for minimum of 7 years
Secondary	Non-Motor Symptoms Scale, NMSS	Score ranges from 0 to 360, higher scores mean a worseoutcome.	Followed for minimum of 7 years
Secondary	Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT		Followed for minimum of 7 years
Secondary	8-item Parkinson's Disease Questionnaire (PDQ-8)		Followed for minimum of 7 years
Secondary	5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L		Followed for minimum of 7 years
Secondary	Levodopa Equivalent Daily Dose, LEDD		Followed for minimum of 7 years
Secondary	Adverse Events, Severe Adverse Events		Followed for minimum of 7 years