Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial

Gordon Duffley; Aniko Szabo; Barbara J Lutz; Emily C Mahoney-Rafferty; Christopher W Hess; Adolfo Ramirez-Zamora; Pamela Zeilman; Kelly D Foote; Shannon Chiu; Michael H Pourfar; Clarisse Goas Cnp; Jennifer L Wood; Ihtsham U Haq; Mustafa S Siddiqui; Mitra Afshari; Melissa Heiry; Jennifer Choi; Monica Volz; Jill L Ostrem; Marta San Luciano; Nicki Niemann; Andrew Billnitzer; Daniel Savitt; Arjun Tarakad; Joohi Jimenez-Shahed; Camila C Aquino; Michael S Okun; Christopher R Butson

doi:10.1016/j.parkreldis.2023.105346

Interactive mobile application for Parkinson's disease deep brain stimulation (MAP DBS): An open-label, multicenter, randomized, controlled clinical trial

Parkinsonism Relat Disord. 2023 Apr:109:105346. doi: 10.1016/j.parkreldis.2023.105346. Epub 2023 Mar 16.

Authors

Gordon Duffley¹, Aniko Szabo², Barbara J Lutz³, Emily C Mahoney-Rafferty⁴, Christopher W Hess⁴, Adolfo Ramirez-Zamora⁴, Pamela Zeilman⁴, Kelly D Foote⁴, Shannon Chiu⁴, Michael H Pourfar⁵, Clarisse Goas Cnp⁶, Jennifer L Wood⁶, Ihtsham U Haq⁷, Mustafa S Siddiqui⁶, Mitra Afshari⁸, Melissa Heiry⁹, Jennifer Choi⁹, Monica Volz⁹, Jill L Ostrem⁹, Marta San Luciano⁹, Nicki Niemann¹⁰, Andrew Billnitzer¹¹, Daniel Savitt¹¹, Arjun Tarakad¹¹, Joohi Jimenez-Shahed¹², Camila C Aquino¹³, Michael S Okun⁴, Christopher R Butson¹⁴

Affiliations

¹ Scientific Computing and Imaging Institute, University of Utah, Salt Lake City, UT, USA; Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.
² Division of Biostatistics, Institute for Health & Equity, Medical College of Wisconsin, Milwaukee, WI, USA.
³ School of Nursing, University of North Carolina-Wilmington, Wilmington, NC, USA.
⁴ Norman Fixel Institute for Neurological Diseases, Program for Movement Disorders and Neurorestoration, Departments of Neurology and Neurosurgery, University of Florida, Gainesville, FL, USA.
⁵ Center for Neuromodulation, New York University Langone Medical Center, New York, NY, USA.
⁶ Department of Neurology, Wake Forest School of Medicine, Winston Salem, NC, USA.
⁷ Department of Neurology, University of Miami, Miami, FL, USA.
⁸ Department of Neurological Sciences, Section of Movement Disorders, Rush University, Chicago, IL, USA.
⁹ Weill Institute of Neurosciences, UCSF Movement Disorder and Neuromodulation Center, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.
¹⁰ Department of Neurology, Barrow Neurological Institute, Phoenix, AZ, USA.
¹¹ Department of Neurology, Baylor College of Medicine, Houston, TX, USA.
¹² Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹³ Department of Neurology, University of Utah, Salt Lake City, UT, USA; Department of Clinical Neurosciences and Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.
¹⁴ Scientific Computing and Imaging Institute, University of Utah, Salt Lake City, UT, USA; Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA; Norman Fixel Institute for Neurological Diseases, Program for Movement Disorders and Neurorestoration, Departments of Neurology and Neurosurgery, University of Florida, Gainesville, FL, USA; Department of Neurology, University of Utah, Salt Lake City, UT, USA; Departments of Neurosurgery, and Psychiatry, University of Utah, Salt Lake City, UT, USA. Electronic address: butsonc@ufl.edu.

PMID: 36966051
DOI: 10.1016/j.parkreldis.2023.105346

Abstract

Introduction: Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease (PD), but its efficacy is tied to DBS programming, which is often time consuming and burdensome for patients, caregivers, and clinicians. Our aim is to test whether the Mobile Application for PD DBS (MAP DBS), a clinical decision support system, can improve programming.

Methods: We conducted an open-label, 1:1 randomized, controlled, multicenter clinical trial comparing six months of SOC standard of care (SOC) to six months of MAP DBS-aided programming. We enrolled patients between 30 and 80 years old who received DBS to treat idiopathic PD at six expert centers across the United States. The primary outcome was time spent DBS programming and secondary outcomes measured changes in motor symptoms, caregiver strain and medication requirements.

Results: We found a significant reduction in initial visit time (SOC: 43.8 ± 28.9 min n = 37, MAP DBS: 27.4 ± 13.0 min n = 35, p = 0.001). We did not find a significant difference in total programming time between the groups over the 6-month study duration. MAP DBS-aided patients experienced a significantly larger reduction in UPDRS III on-medication scores (-7.0 ± 7.9) compared to SOC (-2.7 ± 6.9, p = 0.01) at six months.

Conclusion: MAP DBS was well tolerated and improves key aspects of DBS programming time and clinical efficacy.

Publication types

Randomized Controlled Trial
Multicenter Study
Research Support, N.I.H., Extramural

MeSH terms

Adult
Aged
Aged, 80 and over
Deep Brain Stimulation*
Humans
Middle Aged
Mobile Applications*
Parkinson Disease* / complications
Subthalamic Nucleus*
Treatment Outcome

Grants and funding

R01 NR014852/NR/NINR NIH HHS/United States