Objective: To evaluate psychosocial factors impacting the number of hours of participation in the first five months of a time-intensive deep brain stimulation (DBS) study.

Background: Capable and motivated research participants are essential to the success of many clinical trials, yet psychosocial factors affecting degree of participant involvement remain unclear.¹

Method: Twenty individuals with either Parkinson’s disease or dystonia were evaluated by a clinical neuropsychologist prior to enrollment in a study involving a sensing-enabled DBS device that allows concurrent recording of neural data while delivering therapeutic stimulation. Participants underwent neuropsychological testing and completed mood questionnaires. Subjects were encouraged to record neural data using a patient-facing application as much as possible for the first five months following DBS implantation.² Subjects’ enrollment duration ranged from 6-37 months, thus the first five months represent contributions across participants. Baseline psychosocial results were compared to number of hours of participation.

Results: Participants collected up to 399 hours of data (210.55±94.19). Subjects who were married (n=17, 230.35±90.69 hours) contributed significantly greater mean hours than unmarried subjects without a long-term partner (n=3, 98.67±28.36 hours; t=2.44, p=0.025). Data showed a trend where subjects whose caregiver attended the evaluation (n=13, 241.0±99.35 hours) recorded more mean hours than subjects who attended alone (n=7, 154.14±64.1 hours; t=2.08, p=0.052). Married subjects with increased irritability (n=8, 165.75±53.75 hours) streamed significantly fewer mean hours than those without (n=9, 287.78±77.71 hours; t=3.72, p=0.002).

Conclusion: In this complex DBS study requiring at-home streaming, caregiver support was associated with a higher degree of participation. Individuals with movement disorders often overcome greater obstacles than the general public to participate in time-intensive research studies, and caregiver support may increase a participant’s capability and motivation.³ Subjects with increased irritability may be more easily frustrated while operating the required technology or collaborating with their caregivers and research team, possibly decreasing compliance. Further associations between mood, cognition and participation will be explored in the future.

References: 1. Hao Jin, Min Cui & Junwei Liu (2020) Factors affecting people’s attitude toward participation in medical research: a systematic review, Current Medical Research and Opinion, 36:7, 1137-1143, DOI: 10.1080/03007995.2020.1760807
2. Gilron, R., Little, S., Perrone, R., Wilt, R., de Hemptinne, C., Yaroshinsky, M. S., Racine, C. A., Wang, S. S., Ostrem, J. L., Larson, P. S., Wang, D. D., Galifianakis, N. B., Bledsoe, I. O., San Luciano, M., Dawes, H. E., Worrell, G. A., Kremen, V., Borton, D. A., Denison, T., & Starr, P. A. (2021). Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson’s disease. Nature biotechnology, 39(9), 1078–1085. https://doi.org/10.1038/s41587-021-00897-5
3. Vaswani, P. A., Tropea, T. F., & Dahodwala, N. (2020). Overcoming Barriers to Parkinson Disease Trial Participation: Increasing Diversity and Novel Designs for Recruitment and Retention. Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics, 17(4), 1724–1735. https://doi.org/10.1007/s13311-020-00960-0

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MDS Abstracts - https://www.mdsabstracts.org/abstract/psychosocial-factors-impacting-participation-in-a-time-intensive-deep-brain-stimulation-study-of-individuals-with-parkinsons-disease-and-dystonia/