Parkinson DiseaseFoRMA-DBSNCT05219019

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

An observational study of Parkinson Disease, run by Boston Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Parkinson Disease
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2022to Feb 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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

Who may be able to join

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

Who cannot join

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

About this study

Read the 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
Keywords: Deep brain stimulation (DBS), Remote monitoring, Subthalamic nucleus (STN), Internal globus pallidus (GPi), Patient Global Impression of Change (PGIC), Activities Balance Confidence Scale (ABC), Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05219019
Study group	Role	What they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of remotely assessing gait speed during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess gait speed.
Measured: 20 weeks
Feasibility of remotely assessing functional mobility during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess functional mobility.
Measured: 20 weeks
Feasibility of remotely assessing balance during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess balance.
Measured: 20 weeks

Secondary outcomes (12)

Mobility assessment: 4 meter walk
Gait speed as performed during the 4-meter walk: Measured as time taken to walk 4 meters in seconds.
Measured: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Timed up and go (TUG)
The TUG assesses mobility, balance, walking ability and fall risk in older adults and has been validated showing good agreement between in-person and telehealth and raters. On the command, "go" the patient rises from the chair, walks 3 meters at a comfortable safe pace, turns and walks back to the chair and sits down. Measured as time taken to complete task in seconds.
Measured: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 5 times sit to stand
This is a timed task that requires the participant to stand from a seated position five times in a row. Measured as time taken to complete task in seconds.
Measured: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 360 degree turns
The 360 degree turn test is a measure of dynamic balance in which the participant turns in a complete circle. Measured as time taken to complete task in seconds.
Measured: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Activity-specific balance confidence (ABC) scale
Self-reported confidence in performing 16 activities without losing balance. Participants rate using an 11-point likert-type scale, from 0% (no confidence) to 100% (completely confident) with 10% increments. A total score will be calculated as the mean of the items.
Measured: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Single-leg stance
Amount of time participant is able to stand on one leg (performed for each leg), measured in seconds.
Measured: Day -28, 21, 42, 56, 70
Movement disorders
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV
The Movement Disorder Society's Unified Parkinson's Disease Rating Scales (MDS-UPDRS) consists of 65 items across four domains: non-motor experiences, motor experiences, a motor examination, and motor complications, rated from 0 (normal) to 4 (severe). Subscales and a total score are calculated by adding items. A higher score is a worse outcome and indicates more severe symptoms of Parkinson's disease.
Measured: day -42 and day 84
Quality of Life in PD
The Parkinson's Disease Questionnaire (PDQ-39) will be used to assess living difficulties across 8 dimensions of daily living including mobility subscores.
The PDQ-39 assesses life concerns of individuals with PD. It is composed of a summary index and eight domain scores-mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each item is rated on a 0 (never) to 4 (always) scale. A higher score indicates a higher self-perceived frequency of quality of life and health problems in the past month that are due to the disease, with each domain normed to a scale on which 0 indicating never a problem and 100 always a problem. The summary index is the average of the normed domain scores. A higher score is a worse outcome for quality of life.
Measured: day -42 and day 84
Change in 3-day step count before DBS
Step count will be measured continuously by a StepWatch4 over a 3 day period.
Measured: day -42, day 84
Change in amount of time spent with tremor and dyskinesia
The amount of time spent with tremor and dyskinesia will be measured with the Apple watch.
Measured: baseline, day 84
Patient global impression of change
The Patient Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the patient to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.
Measured: baseline, day 28, 42, 56, 70 and 84
Clinician global impression of change
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.
Measured: baseline, day 28, 42, 56, 70 and 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2022Feb 2023

First posted1 Feb 2022
Study startJun 2022 (estimated)
Primary completionFeb 2023 (estimated)
Study completionFeb 2023 (estimated)

Why it stopped: Insufficient interest by potential participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boston Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05219019
Sponsor's protocol ID: H-41349
Acronym: FoRMA-DBS
Status last verified: Jul 2022
First submitted: 14 Dec 2021
Last updated: 13 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28814455
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.
PubMed 26319759
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.
PubMed 16943402
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.
PubMed 26886406
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.
PubMed 30287051
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.
PubMed 25904081
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.
PubMed 28571034
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.
PubMed 33316487
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.
PubMed 33536284
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.
PubMed 23406026
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.
PubMed 24903924
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.
PubMed 19126811
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.
PubMed 33104873
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.
PubMed 26736231
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.
PubMed 33006811

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
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Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility of Remote Measures and Assessments in Deep Brain Stimulation for Parkinson's Disease (FoRMA-DBS)
ClinicalTrials.gov ID: NCT05219019
Acronym / sponsor ID: FoRMA-DBS / H-41349
Conditions: Parkinson Disease
Keywords: Deep brain stimulation (DBS), Remote monitoring, Subthalamic nucleus (STN), Internal globus pallidus (GPi), Patient Global Impression of Change (PGIC), Activities Balance Confidence Scale (ABC), Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Study type: Observational
Recruitment status: WithdrawnReason stopped: Insufficient interest by potential participants.
Enrolment: 0 participants (actual)
Lead sponsor: Boston Medical CenterUniversity, hospital or other
Study start: Jun 2022 (estimated)
Primary completion: Feb 2023 (estimated)
Study completion: Feb 2023 (estimated)
First posted: 1 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: 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

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Feasibility of remotely assessing gait speed during DBS therapy initiation
Time frame: 20 weeks
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess gait speed.
Feasibility of remotely assessing functional mobility during DBS therapy initiation
Time frame: 20 weeks
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess functional mobility.
Feasibility of remotely assessing balance during DBS therapy initiation
Time frame: 20 weeks
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess balance.

12 secondary outcomes

Mobility assessment: 4 meter walk
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Timed up and go (TUG)
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 5 times sit to stand
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 360 degree turns
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Activity-specific balance confidence (ABC) scale
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Single-leg stance
Time frame: Day -28, 21, 42, 56, 70
Movement disorders
Time frame: day -42 and day 84
Quality of Life in PD
Time frame: day -42 and day 84
Change in 3-day step count before DBS
Time frame: day -42, day 84
Change in amount of time spent with tremor and dyskinesia
Time frame: baseline, day 84
Patient global impression of change
Time frame: baseline, day 28, 42, 56, 70 and 84
Clinician global impression of change
Time frame: baseline, day 28, 42, 56, 70 and 84

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Background: PubMed 28814455Beck 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.
Background: PubMed 26319759Collomb-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.
Background: PubMed 16943402Deuschl 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.
Background: PubMed 26886406Dorsey 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.
Background: PubMed 30287051GBD 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.
Background: PubMed 25904081Kalia 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.
Background: PubMed 28571034Li 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.
Background: PubMed 33316487Ma 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.
Background: PubMed 33536284Powers 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.
Background: PubMed 23406026Schuepbach 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.
Background: PubMed 24903924Soileau 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.
Background: PubMed 19126811Weaver 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ludy Shih, MD MMSc principal investigator

Boston Medical Center

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boston Medical Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of remotely assessing gait speed during DBS therapy initiation (time frame: 20 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05219019, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.