Objective: To systematically evaluate the representation of women participants in clinical trials of deep brain stimulation (DBS) for movement disorders and to estimate pooled proportions of female enrolment across different indications.

Background: DBS is an established treatment for several movement disorders, including Parkinson’s disease (PD), dystonia, tremor, and tic disorders. Despite increasing utilization, concerns remain regarding sex disparities in access to DBS and participation in DBS-related clinical trials. Previous studies suggest that women may be underrepresented in DBS cohorts relative to disease prevalence (1,2). Underrepresentation limits the generalizability of findings, may obscure sex-specific treatment responses, and perpetuates inequities in healthcare research.

Method: We will conduct a systematic review and meta-analysis following PRISMA-P guidelines. Electronic databases (MEDLINE, Scopus, Web of Science, and Cochrane CENTRAL) will be searched for studies published from January 1990 onward. Eligible studies will include randomized controlled trials, non-randomized controlled trials, prospective studies, and registry-based studies reporting DBS cohorts for movement disorder indications. Two groups of reviewers will independently screen studies, extract data, and assess risk of bias (Cochrane Risk of Bias 2.0 for randomized trials and Newcastle–Ottawa Scale for observational studies). The primary outcome will be the proportion of women participants enrolled. A meta-analysis of proportions will be conducted using random-effects models. Subgroup analyses will estimate women representation by clinical indication (PD, dystonia, tremor, tics/Tourette syndrome, chorea, and tardive syndromes). Secondary analyses will evaluate etiology-wise proportions, temporal trends and geographic variation.

Results: This study will provide the first quantitative synthesis of women representation in DBS clinical trials across movement disorders.

Conclusion: Understanding sex representation in DBS trials is essential to ensure equitable research participation and to support the development of evidence-based therapies that are generalizable to both women and men.

References: 1. Meoni S, Macerollo A, Moro E. Sex differences in movement disorders. Nat Rev Neurol. 2020;16(2):84-96. doi:10.1038/s41582-019-0294-x
2. Shpiner DS, Di Luca DG, Cajigas I, et al. Gender Disparities in Deep Brain Stimulation for Parkinson’s Disease. Neuromodulation. 2019;22(4):484-488. doi:10.1111/ner.12973

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MDS Abstracts - https://www.mdsabstracts.org/abstract/representation-of-women-in-deep-brain-stimulation-trials-in-movement-disorders-protocol-for-a-systematic-review-and-meta-analysis/