Parkinson Disease
Conditions
Keywords
deep brain stimulation, subthalamic nucleus, globus pallidus interna, asymmetric deep brain stimulation
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.
Interventions
PROCEDUREDeep 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.
Sponsors
Huashan Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Guangzhou Medical University
West China Hospital
Second Affiliated Hospital of Soochow University
Tianjin Huanhu Hospital
Guangzhou General Hospital of Guangzhou Military Command
The Affiliated Hospital of Xuzhou Medical University
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III) | Followed for minimum of 7 years | Score ranges from 0 to 132, higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-Up-Go (TUG) task | Followed for minimum of 7 years | — |
| Berg Balance Scale, BBS | Followed for minimum of 7 years | Score ranges from 0 to 132, higher scores mean a better outcome. |
| Gait and Falls Questionnaire, GFQ | Followed for minimum of 7 years | Score ranges from 0 to 64, higher scores mean a worse outcome. |
| Montreal Cognitive Assessment (MoCA) | Followed for minimum of 7 years | — |
| Beck Depression Inventory, BDI | Followed for minimum of 7 years | — |
| Beck Anxiety Inventory, BAI | Followed for minimum of 7 years | — |
| Apathy Estimation Scale, AES | Followed for minimum of 7 years | — |
| Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV | Followed for minimum of 7 years | Score ranges from 0 to 128, higher scores mean a worse outcome. |
| Epworth Sleepiness Scale, ESS | Followed for minimum of 7 years | — |
| Non-Motor Symptoms Scale, NMSS | Followed for minimum of 7 years | Score ranges from 0 to 360, higher scores mean a worseoutcome. |
| Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT | Followed for minimum of 7 years | — |
| 8-item Parkinson's Disease Questionnaire (PDQ-8) | Followed for minimum of 7 years | — |
| 5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L | Followed for minimum of 7 years | — |
| Levodopa Equivalent Daily Dose, LEDD | Followed for minimum of 7 years | — |
| Adverse Events, Severe Adverse Events | Followed for minimum of 7 years | — |
| Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF | Followed for minimum of 7 years | True-or-false questions screening the obsessive-compulsive behaviors in parkinson's disease |
Contacts
Primary ContactDianyou Li, MD, PhD
Backup ContactChencheng Zhang, MD, PhD
Outcome results
None listed