NeuralCipher Research overview
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Abstract OBJECTIVE: Insomnia, a prevalent and challenging non-motor symptom of Parkinson's disease (PD), lacks specific acupuncture efficacy data within the PD patient population. The current study is designed to evaluate the effectiveness and safety of electroacupuncture (EA) in comparison to sham electroacupuncture (SA) for PD-related insomnia treatment. DESIGN, SETTING, AND PARTICIPANTS: We will conduct a multicenter, participant-and assessor-blinded, randomized, sham-controlled clinical trial across seven neurology sites in China. Participants diagnosed with PD and experiencing insomnia will be randomly assigned to receive either EA or SA in a 1:1 ratio. INTERVENTIONS: The trial intervention will consist of an 8-week treatment phase for EA or SA, complemented by a subsequent 12-week follow-up period. MAIN OUTCOMES AND MEASURES: The primary outcome will be the change in the Parkinson's Disease Sleep Scale-2 (PDSS-2) score at the end of the intervention (week 8). A range of secondary subjective sleep assessments will also be utilized, including the Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), and the rapid eye movement sleep behavior disorder (RBD) screening questionnaire (RBDSQ). Additionally, scores from the Movement Disorder Society Unified Parkinson’s Rating Scale parts II and III (MDS-UPDRS II and III), and the Parkinson's disease questionnaire (PDQ-39) will be evaluated. For secondary objective sleep parameters, polysomnography (PSG) will provide data on total sleep time (TST), sleep efficiency (SE), wake after sleep onset (WASO), sleep onset latency, REM latency, the proportion of each sleep stage (N1, N2, N3, and REM), the apnea-hypopnea index (AHI), and mean sleep latency (MSL). TRIAL REGISTER: This trial was registered with the Chinese Clinical Trial Registry on February 26, 2024, https://www.chictr.org.cn/, ChiCTR2400081162.
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