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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time-Up-Go (TUG) task |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dianyou Li, MD, PhD | Contact | 13817864569 | ldy11483@rjh.com.cn | |
| Chencheng Zhang, MD, PhD | Contact | 18217122884 | i@cczhang.org |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| First Affiliated Hospital, Sun Yat-Sen University |
| OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| West China Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Tianjin Huanhu Hospital | OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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| Followed for minimum of 7 years |
| Berg Balance Scale, BBS | Score ranges from 0 to 132, higher scores mean a better outcome. | Followed for minimum of 7 years |
| Gait and Falls Questionnaire, GFQ | Score ranges from 0 to 64, higher scores mean a worse outcome. | Followed for minimum of 7 years |
| 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 |
| 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 |
| Epworth Sleepiness Scale, ESS | Followed for minimum of 7 years |
| Non-Motor Symptoms Scale, NMSS | Score ranges from 0 to 360, higher scores mean a worseoutcome. | Followed for minimum of 7 years |
| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |