Objective: The objective of this study is to evaluate a pragmatic clinical workflow and real-world implementation of adaptive Deep Brain Stimulation (aDBS) through integrated clinical, neurophysiological, digital, and qualitative assessments.

Background: aDBS has been shown to improve symptom control in Parkinson’s disease through the use of neural biomarkers to dynamically adjust stimulation. However, translation of aDBS into routine care requires evaluation not only of clinical efficacy but also of the feasibility, resource requirements, and acceptability of implementing aDBS within existing DBS clinical workflows.

Method: This prospective mixed-methods study includes Parkinson’s disease patients implanted with sensing-enabled neurostimulators in which aDBS is being activated for the first time. Clinical workflow metrics will be systematically captured, including programming duration, total clinic time per patient, clinician training requirements, and the learning curve associated with adopting the new workflow. Clinical outcomes will be assessed before and after aDBS implementation using the Movement Disorder Society Unified Parkinson’s Disease Rating Scale, Non-motor Symptoms Scale, Parkinson’s Disease Sleep Scale, and the Canadian Occupational Performance Measure. Neural biomarkers will be analysed through local field potential recordings from the implanted device. Continuous movement data will be collected using a lumbar wearable sensor to examine relationships between accelerometry-derived motor activity and neural signals. In parallel, semi-structured interviews with patients, carers, and clinicians will explore experiences, satisfaction, and perceived impact of aDBS implementation. Quantitative outcomes will be analysed using within-subject comparisons and signal correlation analyses, while qualitative data will undergo reflexive thematic analysis.

Results: This study will generate integrated clinical, neurophysiological, digital, and workflow data to characterize the feasibility, effectiveness, and operational demands of implementing aDBS in routine care.

Conclusion: By combining treatment evaluation with clinical workflow analysis, this study will provide evidence to inform the scalable and cost-effective integration of aDBS into routine Parkinson’s disease management.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/implementing-adaptive-deep-brain-stimulation-in-parkinsons-disease-a-multimodal-mixed-methods-evaluation-of-a-pragmatic-clinical-workflow/