Acupuncture for Cognitive Impairment in Parkinson’s Disease: A Randomized Controlled Trail Protocol (Preprint)

BACKGROUND Cognitive impairment is a common non-motor symptom of Parkinson's disease, significantly affecting patients' expected lifespan and quality of life, diminishing the well-being of family members, and placing an additional economic burden on society. Although some studies suggest that acupuncture may alleviate cognitive impairment, the existing research is limited in scale. OBJECTIVE This study aims to evaluate the clinical efficacy of acupuncture in treating cognitive impairment associated with Parkinson's disease. METHODS This study protocol outlines a randomized, two-arm, single-center clinical trial to be conducted at Beijing Hospital of Traditional Chinese Medicine, affiliated with Capital Medical University. 72 eligible Parkinson’s disease patients with cognitive impairment will be randomized equally to acupuncture or sham-acupuncture groups. The total duration of the study will be 20 weeks, consisting of an 8-week intervention period and a 12-week follow-up period. Participants will undergo acupuncture treatment three times per week. The primary outcome will be the score of (MoCA and PD-CRS). Secondary outcomes will include EEG assessments, the T&T olfactometer, routine blood tests, blood lipid levels, and the Health-Related Quality of Life Questionnaire (PDQ-39). Outcomes will be assessed at baseline, and at the 8th and 20th weeks. RESULTS - CONCLUSIONS This study offers clinical evidence supporting acupuncture as a potential therapeutic option for cognitive impairment in Parkinson's disease, potentially guiding future treatment strategies. Despite challenges such as controlling placebo effects and implementing sham-needle interventions, we aim to mitigate these biases through rigorous experimental design and standardized procedures. CLINICALTRIAL Chinese Clinical Trial Registry（ChiCTR）ChiCTR2400087389. Registered on 26 July 2024