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Year : 2018  |  Volume : 3  |  Issue : 2  |  Page : 66-70

Deep brain stimulation for the treatment of moderate-to-severe Alzheimer’s disease: Study protocol for a prospective self-controlled trial

Department of Neurosurgery, The 101st Hospital of PLA, Wuxi, Jiangsu Province, China

Correspondence Address:
Wei Lin
Department of Neurosurgery, The 101st Hospital of PLA, Wuxi, Jiangsu Province
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2542-3975.235150

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Background and objectives: Previous studies have shown that deep brain stimulation can improve clinical symptoms in patients with mild Alzheimer’s disease, but the therapeutic effect in patients with moderate-to-severe Alzheimer’s disease remains unclear. Therefore, we intend to assess the therapeutic effect of deep brain stimulation on moderate-to-severe Alzheimer’s disease through a 24-month follow-up visit. Design: A prospective single-center, self-controlled study. Methods: This trial will be performed at the 101st Hospital of PLA, Wuxi, China. We will include 20 patients with moderate-to-severe Alzheimer’s disease who will be given bilateral deep brain stimulation via an implant located beside the fornical column. Outcome measures: The primary outcome measure is the percent of patients whose scores on the Mini Mental State Examination have improved after 24 months. The secondary outcome measures include the percent of patients whose scores on the Mini Mental State Examination Scale have improved at other visits, their Montreal Cognitive Assessment-Basic score, Rey-Osterrieth Complex Figure Test score, score on the delayed recall of the Rey-Osterrieth Complex Figure Test, trail making test score, Hamilton Rating Scale for Depression score, functional magnetic resonance imaging results, functional PET imaging results at each visit point, and the incidence of adverse events. Discussion: This trial will provide feasible, objective, and quantifiable evidence for deep brain stimulation in the clinical treatment of moderate-to-severe Alzheimer’s disease. Ethics and dissemination: This study protocol was approved by the Institution Review Board of the 101st Hospital of PLA in China (approval No. L2017002) in December 2016. Design of the study was finished in October 2016, and registered in August 2017. Participant recruitment was started at October 2017, and was expected to be finished within 12 months. Data analysis will be completed until October 2020. The results of the study will be disseminated through presentations at peer-reviewed publications. Trial registration: This trial was registered in the Chinese Clinical Trial Registry with registration No. ChiCTR-ONC-17012311 (version 2.0).

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