Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial
Introduction Gait difficulties are common in Parkinson’s disease (PD) and cause significant disability. These symptoms are often resistant to treatment. Spinal cord stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of patients with PD. The mechanism of a...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Neurology Open |
| Online Access: | https://neurologyopen.bmj.com/content/4/2/e000333.full |
| _version_ | 1797774708804943872 |
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| author | Nicola Pavese Jens Christian Hedemann Sørensen Elena Moro Andreas Nørgaard Glud Victor S Hvingelby Miriam Højholt Terkelsen Erik L Johnsen Mette Møller Erik Hvid Danielsen Tove Henriksen Yen Tai Anne Sofie Møller Andersen Kaare Meier Per Borghammer |
| author_facet | Nicola Pavese Jens Christian Hedemann Sørensen Elena Moro Andreas Nørgaard Glud Victor S Hvingelby Miriam Højholt Terkelsen Erik L Johnsen Mette Møller Erik Hvid Danielsen Tove Henriksen Yen Tai Anne Sofie Møller Andersen Kaare Meier Per Borghammer |
| author_sort | Nicola Pavese |
| collection | DOAJ |
| description | Introduction Gait difficulties are common in Parkinson’s disease (PD) and cause significant disability. These symptoms are often resistant to treatment. Spinal cord stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of patients with PD. The mechanism of action is unclear, and some patients are non-responders. With this double-blind, placebo-controlled efficacy and feasibility clinical and imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also aim to identify clinical and imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection.Methods and analysis A total of 14 patients will be assessed with clinical rating scales and gait evaluations at baseline, and at 6 and 12 months after SCS implantation. They will also receive serial 18F-deoxyglucose and 18FEOBV PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function. The first two patients will be included in an open pilot study while the rest will be randomised to receive active treatment or placebo (no stimulation) for 6 months. From this point, the entire cohort will enter an open label active treatment phase for a subsequent 6 months.Ethics and dissemination This study was reviewed and approved by the Committee on Health Research Ethics, Central Denmark RM. It is funded by the Danish Council for Independent Research. Independent of outcome, the results will be published in peer-reviewed journals and presented at national and international conferences.Trial registration number NCT05110053; ClinicalTrials.gov Identifier. |
| first_indexed | 2024-03-12T22:25:03Z |
| format | Article |
| id | doaj.art-d5cfe35b2e994bab9b8c3404132ffbdd |
| institution | Directory Open Access Journal |
| issn | 2632-6140 |
| language | English |
| last_indexed | 2024-03-12T22:25:03Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Neurology Open |
| spelling | doaj.art-d5cfe35b2e994bab9b8c3404132ffbdd2023-07-22T10:00:07ZengBMJ Publishing GroupBMJ Neurology Open2632-61402022-08-014210.1136/bmjno-2022-000333Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trialNicola Pavese0Jens Christian Hedemann Sørensen1Elena Moro2Andreas Nørgaard Glud3Victor S Hvingelby4Miriam Højholt Terkelsen5Erik L Johnsen6Mette Møller7Erik Hvid Danielsen8Tove Henriksen9Yen Tai10Anne Sofie Møller Andersen11Kaare Meier12Per Borghammer13Department of Clinical Medicine—Nuclear Medicine and PET Center, Aarhus University, Aarhus, DenmarkDepartment of Clinical Medicine, Aarhus University, Aarhus, DenmarkDepartment of Psychiatry, Neurology, Neurological Rehabilitation and Forensic Medicine, Grenoble Alpes University Hospital, Grenoble, Auvergne-Rhône-Alpes, FranceDepartment of Clinical Medicine, Aarhus University, Aarhus, DenmarkDepartment of Clinical Medicine—Nuclear Medicine and PET Center, Aarhus University, Aarhus, DenmarkDepartment of Clinical Medicine—Nuclear Medicine and PET Center, Aarhus University, Aarhus, DenmarkDepartment of Neurology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Neurology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Neurology, Aarhus University Hospital, Aarhus, DenmarkDepartment of Neurology, Bispebjerg Hospital, Copenhagen, DenmarkDepartment of Neurosciences, Imperial College Healthcare NHS Trust, London, UKDepartment of Neurosurgery, Aarhus University Hospital, Aarhus, DenmarkDepartment of Clinical Medicine, Aarhus University, Aarhus, DenmarkDepartment of Clinical Medicine, Aarhus University, Aarhus, DenmarkIntroduction Gait difficulties are common in Parkinson’s disease (PD) and cause significant disability. These symptoms are often resistant to treatment. Spinal cord stimulation (SCS) has been found to improve gait, including freezing of gait, in a small number of patients with PD. The mechanism of action is unclear, and some patients are non-responders. With this double-blind, placebo-controlled efficacy and feasibility clinical and imaging study, we aim to shed light on the mechanism of action of SCS and collect data to inform development of a scientifically sound clinical trial protocol. We also aim to identify clinical and imaging biomarkers at baseline that could be predictive of a favourable or a negative outcome of SCS and improve patient selection.Methods and analysis A total of 14 patients will be assessed with clinical rating scales and gait evaluations at baseline, and at 6 and 12 months after SCS implantation. They will also receive serial 18F-deoxyglucose and 18FEOBV PET scans to assess the effects of SCS on cortical/subcortical activity and brain cholinergic function. The first two patients will be included in an open pilot study while the rest will be randomised to receive active treatment or placebo (no stimulation) for 6 months. From this point, the entire cohort will enter an open label active treatment phase for a subsequent 6 months.Ethics and dissemination This study was reviewed and approved by the Committee on Health Research Ethics, Central Denmark RM. It is funded by the Danish Council for Independent Research. Independent of outcome, the results will be published in peer-reviewed journals and presented at national and international conferences.Trial registration number NCT05110053; ClinicalTrials.gov Identifier.https://neurologyopen.bmj.com/content/4/2/e000333.full |
| spellingShingle | Nicola Pavese Jens Christian Hedemann Sørensen Elena Moro Andreas Nørgaard Glud Victor S Hvingelby Miriam Højholt Terkelsen Erik L Johnsen Mette Møller Erik Hvid Danielsen Tove Henriksen Yen Tai Anne Sofie Møller Andersen Kaare Meier Per Borghammer Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial BMJ Neurology Open |
| title | Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial |
| title_full | Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial |
| title_fullStr | Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial |
| title_full_unstemmed | Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial |
| title_short | Spinal cord stimulation therapy for patients with Parkinson’s disease and gait problems (STEP-PD): study protocol for an exploratory, double-blind, randomised, placebo-controlled feasibility trial |
| title_sort | spinal cord stimulation therapy for patients with parkinson s disease and gait problems step pd study protocol for an exploratory double blind randomised placebo controlled feasibility trial |
| url | https://neurologyopen.bmj.com/content/4/2/e000333.full |
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