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STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 3  |  Page : 107-120

Wirelessly programmed deep brain stimulation of the bilateral subthalamic nucleus for the treatment of primary Parkinson's disease: study protocol for a multicenter, randomized, parallel-controlled optimal-efficiency trial


1 Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
2 Tangdu Hospital, the Fourth Military Medical University, Xi'an, Shaanxi Province, China
3 Fuwai Hospital of Chinese Academy of Medical Sciences, Beijing, China
4 Changhai Hospital, Shanghai, China
5 West China Hospital, Sichuan University, Chengdu, Sichuan Province, China
6 Rehabilitation Hospital of Sichuan Province, Chengdu, Sichuan Province, China

Correspondence Address:
Dian-you Li
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai
China
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Source of Support: This study was supported by the National Natural Science Foundation of China, No. 81271518, Conflict of Interest: None


DOI: 10.4103/2468-5658.191353

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Background: Deep brain stimulation (DBS) is a commonly used neurosurgical approach for the debilitating motor symptoms of Parkinson's disease (PD). A number of neurostimulation products have been developed, including the Medtronic implantable neurostimulator (Medtronic USA, Inc., USA) and a wirelessly programmed implantable neurostimulator (Sceneray Co. Ltd., China) with protection by independent intellectual property rights in China. This study will validate the safety and efficacy of implantable neurostimulators in the treatment of primary PD. Methods/Design: This is a prospective, single-blind, randomized parallel-controlled optimal-efficiency trial, which will be performed in five research centers. Sixty-four patients with middle-stage and advanced-stage idiopathic PD will be randomly assigned to an experimental group and a control group according to a 1:1 ratio. An implantable neurostimulator will be implanted in each participant in both groups, but the stimulator will be activated within 1 month of surgery in the experimental group, while the patients in the control group will not receive stimulation until 3 months after implantation. After 3 months, patients in both groups will receive stimulation from the implanted neurostimulator. Beginning 6 hours after implantation, all participants will receive anti-PD drugs such as dopamine receptor agonists and compound levodopa. The primary outcome measure in this study will be changes in motor function score (Unified Parkinson's Disease Rating Scale (UPDRS)-III), relative to the baseline value, in patients from each group upon withdrawal of medications for 12 hours at 3 months after surgery. The secondary outcome measures for this study include (1) changes in UPDRS-I, II, III, and IV scores in patients from each group under the influence of medication at 3, 6, 9, and 12 months after surgery relative to baseline values; (2) changes in UPDRS-III scores upon withdrawal of medications 12 months after surgery in stimulation "on" and "off" modes relative to baseline value; (3) patient satisfaction. Safety indices are the numbers and incidences of adverse events. Discussion: This study is the first to investigate the safety and efficacy of a wirelessly programmed implantable neurostimulator enforced with protection by independent intellectual property rights in China through a randomized controlled trial. If safe and effective outcomes are acquired, this implantable neurostimulator will become a new option for treatment of PD patients. Trial registration: This trial was registered at http://www.chictr.org.cn (registration number ChiCTR-INR-16008951) on 1 August 2016. Ethics: The study protocol has been approved by the Ethics Committee of Tangdu Hospital of the Fourth Military Medical University of China (approval number: 2012009); Ethics Committee of Changhai Hospital of China (approval number: CHEC2012-044); Clinical Trial Ethics Committee, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine of China (approval number: 2012-67); Clinical Trial and Biomedical Ethics Committee of West China Hospital of Sichuan University of China (approval number: 2012-7); Ethics Committee of First Affiliated Hospital of Guangzhou Medical University of China (approval number: 2013-8). The study protocol will be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Signed informed consent will be obtained from the patients or their relatives.


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