Neuropsychological and Social Predictors of Participation in a Deep Brain Stimulation Study of Parkinson's Disease and Dystonia

Overview

Journal medRxiv

Date 2024 Jun 10

PMID 38854092

Authors

Amelia Hahn

Ann A Lazar

Stephanie Cernera

Simon Little

Sarah S Wang

Philip A Starr

Caroline A Racine

Affiliations

Soon will be listed here.

Abstract

Objectives: Participation is essential to DBS research, yet circumstances that affect diverse participation remain unclear. Here we evaluate factors impacting participation in an adaptive DBS study of Parkinson's disease (PD) and dystonia.

Methods: Twenty participants were implanted with a sensing-enabled DBS device (Medtronic Summit RC+S) that allows neural data streaming in naturalistic settings and encouraged to stream as much as possible for the first five months after surgery. Using standardized baseline data obtained through neuropsychological evaluation, we compared neuropsychological and social variables to streaming hours.

Results: Marital status and irritability significantly impacted streaming hours (estimate=136.7, bootstrapped ( ) =45.0 to 249.0, =0.016, and estimate=-95.1, =-159.9 to -49.2, =0.027, respectively). These variables remained significant after multivariable analysis. Composite scores on verbal memory evaluations predicted the number of hours of data streamed ( =0.284, estimate=67.7, =20.1 to 119.9, =0.019).

Discussion: Verbal memory impairment, irritability, and lack of a caregiver may be associated with decreased participation. Further study of factors that impact research participation is critical to the sustained inclusion of diverse participants.

References

Macaulay A . Participatory research: What is the history? Has the purpose changed?. Fam Pract. 2016; 34(3):256-258. DOI: 10.1093/fampra/cmw117. View

Grace Cannard K, Hacker M, Molinari A, Heusinkveld L, Currie A, Charles D . Recruitment and Retention in Clinical Trials of Deep Brain Stimulation in Early-Stage Parkinson's Disease: Past Experiences and Future Considerations. J Parkinsons Dis. 2018; 8(3):421-428. DOI: 10.3233/JPD-181381. View

Gilron R, Little S, Perrone R, Wilt R, de Hemptinne C, Yaroshinsky M . Long-term wireless streaming of neural recordings for circuit discovery and adaptive stimulation in individuals with Parkinson's disease. Nat Biotechnol. 2021; 39(9):1078-1085. PMC: 8434942. DOI: 10.1038/s41587-021-00897-5. View

Gorzynska O, McGoohan K, Velayudhan L . Patient and Caregiver Experiences of Participating in Parkinson's Disease Clinical Trials: A Systematic Review of Qualitative Studies. Arch Clin Neuropsychol. 2021; 37(3):654-676. PMC: 9035084. DOI: 10.1093/arclin/acab083. View

Haley S, Southwick L, Parikh N, Rivera J, Farrar-Edwards D, Boden-Albala B . Barriers and Strategies for Recruitment of Racial and Ethnic Minorities: Perspectives from Neurological Clinical Research Coordinators. J Racial Ethn Health Disparities. 2017; 4(6):1225-1236. PMC: 5547022. DOI: 10.1007/s40615-016-0332-y. View

Dreyfus B, Kuri L, Ferri M, Doykos P, Fazeli M, Hofer K . Understanding Hispanic/Latino Participation in Clinical Trials and Observational Studies, and Strategies to Increase Participation: A Targeted Literature Review. J Health Care Poor Underserved. 2023; 34(1):399-424. DOI: 10.1353/hpu.2023.0026. View

Lazaro-Munoz G, Yoshor D, Beauchamp M, Goodman W, McGuire A . Continued access to investigational brain implants. Nat Rev Neurosci. 2018; 19(6):317-318. PMC: 6020153. DOI: 10.1038/s41583-018-0004-5. View

Shpiner D, Di Luca D, Cajigas I, Diaz J, Margolesky J, Moore H . Gender Disparities in Deep Brain Stimulation for Parkinson's Disease. Neuromodulation. 2019; 22(4):484-488. DOI: 10.1111/ner.12973. View

Munoz K, Kostick K, Sanchez C, Kalwani L, Torgerson L, Hsu R . Researcher Perspectives on Ethical Considerations in Adaptive Deep Brain Stimulation Trials. Front Hum Neurosci. 2020; 14:578695. PMC: 7689343. DOI: 10.3389/fnhum.2020.578695. View

10.

Le D, Ozbeki H, Salazar S, Berl M, Turner M, Price O . Improving African American women's engagement in clinical research: A systematic review of barriers to participation in clinical trials. J Natl Med Assoc. 2022; 114(3):324-339. PMC: 9189005. DOI: 10.1016/j.jnma.2022.02.004. View

11.

Dorritie A, Faysel M, Gruessner A, Robakis D . Black and hispanic patients with movement disorders less likely to undergo deep brain stimulation. Parkinsonism Relat Disord. 2023; 115:105811. DOI: 10.1016/j.parkreldis.2023.105811. View

12.

Pollak P . Deep brain stimulation for Parkinson's disease - patient selection. Handb Clin Neurol. 2013; 116:97-105. DOI: 10.1016/B978-0-444-53497-2.00009-7. View

13.

Bonevski B, Randell M, Paul C, Chapman K, Twyman L, Bryant J . Reaching the hard-to-reach: a systematic review of strategies for improving health and medical research with socially disadvantaged groups. BMC Med Res Methodol. 2014; 14:42. PMC: 3974746. DOI: 10.1186/1471-2288-14-42. View

14.

Forsat N, Palmowski A, Palmowski Y, Boers M, Buttgereit F . Recruitment and Retention of Older People in Clinical Research: A Systematic Literature Review. J Am Geriatr Soc. 2020; 68(12):2955-2963. DOI: 10.1111/jgs.16875. View

15.

Elekes F, Sebanz N . Effects of a partner's task on memory for content and source. Cognition. 2020; 198:104221. DOI: 10.1016/j.cognition.2020.104221. View

16.

Memon A, Gelman K, Melott J, Billings R, Fullard M, Catiul C . A systematic review of health disparities research in deep brain stimulation surgery for Parkinson's disease. Front Hum Neurosci. 2023; 17:1269401. PMC: 10641459. DOI: 10.3389/fnhum.2023.1269401. View

17.

Smith S, Johnson G . A systematic review of the barriers, enablers and strategies to embedding translational research within the public hospital system focusing on nursing and allied health professions. PLoS One. 2023; 18(2):e0281819. PMC: 9934318. DOI: 10.1371/journal.pone.0281819. View

18.

Hemphill R, Forsythe L, Heckert A, Amolegbe A, Maurer M, Carman K . What motivates patients and caregivers to engage in health research and how engagement affects their lives: Qualitative survey findings. Health Expect. 2019; 23(2):328-336. PMC: 7104645. DOI: 10.1111/hex.12979. View

19.

Thoma A, Farrokhyar F, McKnight L, Bhandari M . Practical tips for surgical research: how to optimize patient recruitment. Can J Surg. 2010; 53(3):205-10. PMC: 2878987. View

20.

Levin B, Katzen H, Klein B, Llabre M . Cognitive decline affects subject attrition in longitudinal research. J Clin Exp Neuropsychol. 2000; 22(5):580-6. DOI: 10.1076/1380-3395(200010)22:5;1-9;FT580. View