Clinical trial NCT04616521: Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study
Official title: Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: deep brain stimulation
subthalamic nucleus
globus pallidus interna
asymmetric deep brain stimulation
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: The First Affiliated Hospital with Nanjing Medical University
name: First Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Guangzhou Medical University
name: West China Hospital
name: Second Affiliated Hospital of Soochow University
name: Tianjin Huanhu Hospital
name: Guangzhou General Hospital of Guangzhou Military Command
name: The Affiliated Hospital of Xuzhou Medical University
First posted: 2020-11-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)
timeFrame: Followed for minimum of 7 years
Secondary outcomes:
measure: Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV
timeFrame: Followed for minimum of 7 years
measure: Time-Up-Go (TUG) task
timeFrame: Followed for minimum of 7 years
measure: Berg Balance Scale, BBS
timeFrame: Followed for minimum of 7 years
measure: Gait and Falls Questionnaire, GFQ
timeFrame: Followed for minimum of 7 years
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Followed for minimum of 7 years
measure: Beck Depression Inventory, BDI
timeFrame: Followed for minimum of 7 years
measure: Beck Anxiety Inventory, BAI
timeFrame: Followed for minimum of 7 years
measure: Apathy Estimation Scale, AES
timeFrame: Followed for minimum of 7 years
measure: Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF
timeFrame: Followed for minimum of 7 years
measure: Epworth Sleepiness Scale, ESS
timeFrame: Followed for minimum of 7 years
measure: Non-Motor Symptoms Scale, NMSS
timeFrame: Followed for minimum of 7 years
measure: Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT
timeFrame: Followed for minimum of 7 years
measure: 8-item Parkinson's Disease Questionnaire (PDQ-8)
timeFrame: Followed for minimum of 7 years
measure: 5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L
timeFrame: Followed for minimum of 7 years
measure: Levodopa Equivalent Daily Dose, LEDD
timeFrame: Followed for minimum of 7 years
measure: Adverse Events, Severe Adverse Events
timeFrame: Followed for minimum of 7 years
Other outcomes:
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