Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)

NCT ID: NCT05219019

Last Updated: 2022-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2023-02-28

Brief Summary

This is an observational pilot study to assess the feasibility of remote functional assessments of gait, balance, and functional mobility via a telemedicine platform enabled via the Abbott Infinity devices. The clinical care of the participant will not be changed based on the remote functional assessments.

Detailed Description

This is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients with Parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. This study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (DBS).

Ten participants who are deemed surgical candidates for receiving DBS for Parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the Abbott DBS system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. A pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical DBS electrode lead implantation. An at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical DBS electrode lead implantation. Participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for DBS patients.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

PD patients who have elected DBS

Ten individuals with moderate to advanced Parkinson's disease who have elected to undergo deep brain stimulation (DBS) of the subthalamic nucleus (STN) or internal globus pallidus (GPi) as standard of care for management of Parkinson's disease tremor and/or motor complications

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with with Parkinson's disease, as confirmed by the treating investigator, providing written consent to the clinical study
• Participants have been determined by the treating investigator as candidates for DBS
• Participants who have opted to have DBS with the remote-programming capable platform
• Have internet connection at home or wherever participants will be receiving care remotely and be able to participate in telemedicine visits and remote programming

Exclusion Criteria

• Has already had prior surgical lesioning or deep brain stimulation therapy
• Meets criteria for Parkinson's disease dementia in the opinion of the treating investigator
• Does not have capacity for consent as judged by the treating investigator
• Scores less than 24 on the Montreal Cognitive Assessment (MoCA) at standard of care DBS screening, indicating, at least, mild cognitive impairment

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ludy Shih, MD MMSc

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

References

Beck CA, Beran DB, Biglan KM, Boyd CM, Dorsey ER, Schmidt PN, Simone R, Willis AW, Galifianakis NB, Katz M, Tanner CM, Dodenhoff K, Aldred J, Carter J, Fraser A, Jimenez-Shahed J, Hunter C, Spindler M, Reichwein S, Mari Z, Dunlop B, Morgan JC, McLane D, Hickey P, Gauger L, Richard IH, Mejia NI, Bwala G, Nance M, Shih LC, Singer C, Vargas-Parra S, Zadikoff C, Okon N, Feigin A, Ayan J, Vaughan C, Pahwa R, Dhall R, Hassan A, DeMello S, Riggare SS, Wicks P, Achey MA, Elson MJ, Goldenthal S, Keenan HT, Korn R, Schwarz H, Sharma S, Stevenson EA, Zhu W; Connect.Parkinson Investigators. National randomized controlled trial of virtual house calls for Parkinson disease. Neurology. 2017 Sep 12;89(11):1152-1161. doi: 10.1212/WNL.0000000000004357. Epub 2017 Aug 16.

Reference Type: BACKGROUND

PMID: 28814455 (View on PubMed)

Collomb-Clerc A, Welter ML. Effects of deep brain stimulation on balance and gait in patients with Parkinson's disease: A systematic neurophysiological review. Neurophysiol Clin. 2015 Nov;45(4-5):371-88. doi: 10.1016/j.neucli.2015.07.001. Epub 2015 Aug 28.

Reference Type: BACKGROUND

PMID: 26319759 (View on PubMed)

Deuschl G, Schade-Brittinger C, Krack P, Volkmann J, Schafer H, Botzel K, Daniels C, Deutschlander A, Dillmann U, Eisner W, Gruber D, Hamel W, Herzog J, Hilker R, Klebe S, Kloss M, Koy J, Krause M, Kupsch A, Lorenz D, Lorenzl S, Mehdorn HM, Moringlane JR, Oertel W, Pinsker MO, Reichmann H, Reuss A, Schneider GH, Schnitzler A, Steude U, Sturm V, Timmermann L, Tronnier V, Trottenberg T, Wojtecki L, Wolf E, Poewe W, Voges J; German Parkinson Study Group, Neurostimulation Section. A randomized trial of deep-brain stimulation for Parkinson's disease. N Engl J Med. 2006 Aug 31;355(9):896-908. doi: 10.1056/NEJMoa060281.

Reference Type: BACKGROUND

PMID: 16943402 (View on PubMed)

Dorsey ER, Achey MA, Beck CA, Beran DB, Biglan KM, Boyd CM, Schmidt PN, Simone R, Willis AW, Galifianakis NB, Katz M, Tanner CM, Dodenhoff K, Ziman N, Aldred J, Carter J, Jimenez-Shahed J, Hunter C, Spindler M, Mari Z, Morgan JC, McLane D, Hickey P, Gauger L, Richard IH, Bull MT, Mejia NI, Bwala G, Nance M, Shih L, Anderson L, Singer C, Zadikoff C, Okon N, Feigin A, Ayan J, Vaughan C, Pahwa R, Cooper J, Webb S, Dhall R, Hassan A, Weis D, DeMello S, Riggare SS, Wicks P, Smith J, Keenan HT, Korn R, Schwarz H, Sharma S, Stevenson EA, Zhu W. National Randomized Controlled Trial of Virtual House Calls for People with Parkinson's Disease: Interest and Barriers. Telemed J E Health. 2016 Jul;22(7):590-8. doi: 10.1089/tmj.2015.0191. Epub 2016 Feb 17.

Reference Type: BACKGROUND

PMID: 26886406 (View on PubMed)

GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1.

Reference Type: BACKGROUND

PMID: 30287051 (View on PubMed)

Kalia LV, Lang AE. Parkinson's disease. Lancet. 2015 Aug 29;386(9996):896-912. doi: 10.1016/S0140-6736(14)61393-3. Epub 2015 Apr 19.

Reference Type: BACKGROUND

PMID: 25904081 (View on PubMed)

Li D, Zhang C, Gault J, Wang W, Liu J, Shao M, Zhao Y, Zeljic K, Gao G, Sun B. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System. Stereotact Funct Neurosurg. 2017;95(3):174-182. doi: 10.1159/000475765. Epub 2017 Jun 2.

Reference Type: BACKGROUND

PMID: 28571034 (View on PubMed)

Ma Y, Miao S, Zhou R, Zhang Q, Chen H, Liang Y. Application of Remote Deep Brain Stimulation Programming for Parkinson's Disease Patients. World Neurosurg. 2021 Mar;147:e255-e261. doi: 10.1016/j.wneu.2020.12.030. Epub 2020 Dec 13.

Reference Type: BACKGROUND

PMID: 33316487 (View on PubMed)

Powers R, Etezadi-Amoli M, Arnold EM, Kianian S, Mance I, Gibiansky M, Trietsch D, Alvarado AS, Kretlow JD, Herrington TM, Brillman S, Huang N, Lin PT, Pham HA, Ullal AV. Smartwatch inertial sensors continuously monitor real-world motor fluctuations in Parkinson's disease. Sci Transl Med. 2021 Feb 3;13(579):eabd7865. doi: 10.1126/scitranslmed.abd7865.

Reference Type: BACKGROUND

PMID: 33536284 (View on PubMed)

Schuepbach WM, Rau J, Knudsen K, Volkmann J, Krack P, Timmermann L, Halbig TD, Hesekamp H, Navarro SM, Meier N, Falk D, Mehdorn M, Paschen S, Maarouf M, Barbe MT, Fink GR, Kupsch A, Gruber D, Schneider GH, Seigneuret E, Kistner A, Chaynes P, Ory-Magne F, Brefel Courbon C, Vesper J, Schnitzler A, Wojtecki L, Houeto JL, Bataille B, Maltete D, Damier P, Raoul S, Sixel-Doering F, Hellwig D, Gharabaghi A, Kruger R, Pinsker MO, Amtage F, Regis JM, Witjas T, Thobois S, Mertens P, Kloss M, Hartmann A, Oertel WH, Post B, Speelman H, Agid Y, Schade-Brittinger C, Deuschl G; EARLYSTIM Study Group. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22. doi: 10.1056/NEJMoa1205158.

Reference Type: BACKGROUND

PMID: 23406026 (View on PubMed)

Soileau MJ, Persad C, Taylor J, Patil PG, Chou KL. Caregiver burden in patients with Parkinson disease undergoing deep brain stimulation: an exploratory analysis. J Parkinsons Dis. 2014;4(3):517-21. doi: 10.3233/JPD-140380.

Reference Type: BACKGROUND

PMID: 24903924 (View on PubMed)

Weaver FM, Follett K, Stern M, Hur K, Harris C, Marks WJ Jr, Rothlind J, Sagher O, Reda D, Moy CS, Pahwa R, Burchiel K, Hogarth P, Lai EC, Duda JE, Holloway K, Samii A, Horn S, Bronstein J, Stoner G, Heemskerk J, Huang GD; CSP 468 Study Group. Bilateral deep brain stimulation vs best medical therapy for patients with advanced Parkinson disease: a randomized controlled trial. JAMA. 2009 Jan 7;301(1):63-73. doi: 10.1001/jama.2008.929.

Reference Type: BACKGROUND

PMID: 19126811 (View on PubMed)

Xu J, Wang J, Keith S, Zhang M, Yang C, Yuan Q, Qiu Y, Hu X, Wu X. Management of Parkinson's disease patients after DBS by remote programming: preliminary application of single center during quarantine of 2019-nCoV. J Neurol. 2021 Apr;268(4):1295-1303. doi: 10.1007/s00415-020-10273-z. Epub 2020 Oct 26.

Reference Type: BACKGROUND

PMID: 33104873 (View on PubMed)

Chen Y, Hao H, Chen H, Li L. The study on a telemedicine interaction mode for Deep Brain Stimulation postoperative follow-up. Annu Int Conf IEEE Eng Med Biol Soc. 2015;2015:186-9. doi: 10.1109/EMBC.2015.7318331.

Reference Type: BACKGROUND

PMID: 26736231 (View on PubMed)

Zhang C, Zhu K, Lin Z, Huang P, Pan Y, Sun B, Li D. Utility of Deep Brain Stimulation Telemedicine for Patients With Movement Disorders During the COVID-19 Outbreak in China. Neuromodulation. 2021 Feb;24(2):337-342. doi: 10.1111/ner.13274. Epub 2020 Oct 2.

Reference Type: BACKGROUND

PMID: 33006811 (View on PubMed)

Zhang J, Hu W, Chen H, Meng F, Li L, Okun MS. Implementation of a Novel Bluetooth Technology for Remote Deep Brain Stimulation Programming: The Pre- and Post-COVID-19 Beijing Experience. Mov Disord. 2020 Jun;35(6):909-910. doi: 10.1002/mds.28098. Epub 2020 Jun 1. No abstract available.

Reference Type: BACKGROUND

PMID: 32478886 (View on PubMed)

Other Identifiers

H-41349

Identifier Type: -

Identifier Source: org_study_id