Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT)
Introduction Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation;...
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BMJ Publishing Group
2024-11-01
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| author | Philippe De Vloo Maxime Billot Sam Eldabe Anaïs Van Hoylandt Manuel Roulaud Philippe Rigoard Mark Plazier Lisa Goudman Maarten Moens Tom Theys Ann De Smedt Bart Billet Dimitri Vanhauwaert Pieter-Jan Germonpré Jeroen Ceuppens Christ Declerck Hannie Braems Johan Vangeneugden Bart Bryon Thibault Remacle Raf Van Paesschen Sofie Denkens Laura Verschueren Vincent Raymaekers Jean-Pierre Van Buyten Iris Smet Ali Jerjir Michel Turlot Stefaan Goossens Patricia Da Silva Ella Ver Donck Mayken Gorissen |
| author_facet | Philippe De Vloo Maxime Billot Sam Eldabe Anaïs Van Hoylandt Manuel Roulaud Philippe Rigoard Mark Plazier Lisa Goudman Maarten Moens Tom Theys Ann De Smedt Bart Billet Dimitri Vanhauwaert Pieter-Jan Germonpré Jeroen Ceuppens Christ Declerck Hannie Braems Johan Vangeneugden Bart Bryon Thibault Remacle Raf Van Paesschen Sofie Denkens Laura Verschueren Vincent Raymaekers Jean-Pierre Van Buyten Iris Smet Ali Jerjir Michel Turlot Stefaan Goossens Patricia Da Silva Ella Ver Donck Mayken Gorissen |
| author_sort | Philippe De Vloo |
| collection | DOAJ |
| description | Introduction Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation; however, studies in humans are still scarce, pointing towards the need for an evaluation of the effectiveness and safety of DTM SCS in clinical settings. Furthermore, the differential target multiplexed (DTM) algorithm consists of a combination of several programmes, which will presumably consume more energy from the spinal cord stimulation (SCS) battery. Therefore, the objective of DETECT is to investigate the feasibility, effectiveness and safety of DTM SCS in patients with Persistent Spinal Pain Syndrome Type II through a longitudinal cohort study.Methods and analysis DETECT is a prospective multicentre cohort study (n≥250) with a follow-up until 12 months after receiving DTM SCS. The study initiated in October 2021 and is currently still recruiting patients. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 6 and 12 months of DTM SCS. The primary effectiveness endpoint is overall pain intensity, measured with the visual analogue scale. Secondary effectiveness outcome measures are back pain intensity, leg pain intensity, disability, health-related quality of life, pain medication use, functional disability, clinical holistic responder status, self-management, impression of change, work status, pain catastrophising, symptoms of central sensitisation, anxiety, depression and healthcare utilisation. Time spent in different body postures and SCS stimulation parameters will be read out from the pulse generator. The prevalence of technical issues, recharge frequency, (serious) adverse events and the proportion of successful DTM trials will be collected as well. Longitudinal mixed models will be calculated to evaluate the effectiveness of DTM SCS over time.Ethics and dissemination The study protocol was approved by the central Ethics Committee of the Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (B.U.N.1432021000563) and the Ethics Committees of each participating centre. Research findings will be disseminated to key stakeholders through peer-reviewed publications in scientific journals and presentations to clinical audiences.Trial registration number NCT05068011. |
| format | Article |
| id | doaj-art-a5e2e1763b1b45e6856627f8ce3a04e2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-a5e2e1763b1b45e6856627f8ce3a04e22024-11-12T18:45:06ZengBMJ Publishing GroupBMJ Open2044-60552024-11-01141110.1136/bmjopen-2023-083610Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT)Philippe De Vloo0Maxime Billot1Sam Eldabe2Anaïs Van Hoylandt3Manuel Roulaud4Philippe Rigoard5Mark Plazier6Lisa Goudman7Maarten Moens8Tom Theys9Ann De Smedt10Bart BilletDimitri VanhauwaertPieter-Jan GermonpréJeroen CeuppensChrist DeclerckHannie BraemsJohan VangeneugdenBart BryonThibault RemacleRaf Van PaesschenSofie DenkensLaura VerschuerenVincent RaymaekersJean-Pierre Van BuytenIris SmetAli JerjirMichel TurlotStefaan GoossensPatricia Da SilvaElla Ver DonckMayken GorissenDivision of Neurosurgery, University of Toronto, Toronto, Ontario, Canada1 Clinical Geriatric, Centre Hospitalier Universitaire de Limoges, Limoges, FranceDepartment of Pain Medicine, James Cook University Hospital, Middlesbrough, UKAff2 grid.5596.f0000000106687884Department of Oncology, Laboratory of Gynaecologic OncologyKU Leuven, Leuven Cancer Institute Leuven Belgium2 Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, France2 Prismatics Lab, Centre Hospitalier Universitaire de Poitiers, Poitiers, FranceBrai2n, TRI and Department of Neurosurgery, University Hospital Antwerp, Edegem, BelgiumCluster Neurosciences, Center for Neurosciences (C4N), Vrije Universiteit Brussel, Brussel, BelgiumDepartment of Neurosurgery, UZ Brussel, Brussel, BelgiumDepartment of Neurosurgery, KU Leuven University Hospitals, Leuven, BelgiumSTIMULUS research group, Vrije Universiteit Brussel, Brussel, BelgiumIntroduction Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation; however, studies in humans are still scarce, pointing towards the need for an evaluation of the effectiveness and safety of DTM SCS in clinical settings. Furthermore, the differential target multiplexed (DTM) algorithm consists of a combination of several programmes, which will presumably consume more energy from the spinal cord stimulation (SCS) battery. Therefore, the objective of DETECT is to investigate the feasibility, effectiveness and safety of DTM SCS in patients with Persistent Spinal Pain Syndrome Type II through a longitudinal cohort study.Methods and analysis DETECT is a prospective multicentre cohort study (n≥250) with a follow-up until 12 months after receiving DTM SCS. The study initiated in October 2021 and is currently still recruiting patients. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 6 and 12 months of DTM SCS. The primary effectiveness endpoint is overall pain intensity, measured with the visual analogue scale. Secondary effectiveness outcome measures are back pain intensity, leg pain intensity, disability, health-related quality of life, pain medication use, functional disability, clinical holistic responder status, self-management, impression of change, work status, pain catastrophising, symptoms of central sensitisation, anxiety, depression and healthcare utilisation. Time spent in different body postures and SCS stimulation parameters will be read out from the pulse generator. The prevalence of technical issues, recharge frequency, (serious) adverse events and the proportion of successful DTM trials will be collected as well. Longitudinal mixed models will be calculated to evaluate the effectiveness of DTM SCS over time.Ethics and dissemination The study protocol was approved by the central Ethics Committee of the Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (B.U.N.1432021000563) and the Ethics Committees of each participating centre. Research findings will be disseminated to key stakeholders through peer-reviewed publications in scientific journals and presentations to clinical audiences.Trial registration number NCT05068011.https://bmjopen.bmj.com/content/14/11/e083610.full |
| spellingShingle | Philippe De Vloo Maxime Billot Sam Eldabe Anaïs Van Hoylandt Manuel Roulaud Philippe Rigoard Mark Plazier Lisa Goudman Maarten Moens Tom Theys Ann De Smedt Bart Billet Dimitri Vanhauwaert Pieter-Jan Germonpré Jeroen Ceuppens Christ Declerck Hannie Braems Johan Vangeneugden Bart Bryon Thibault Remacle Raf Van Paesschen Sofie Denkens Laura Verschueren Vincent Raymaekers Jean-Pierre Van Buyten Iris Smet Ali Jerjir Michel Turlot Stefaan Goossens Patricia Da Silva Ella Ver Donck Mayken Gorissen Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) BMJ Open |
| title | Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) |
| title_full | Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) |
| title_fullStr | Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) |
| title_full_unstemmed | Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) |
| title_short | Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT) |
| title_sort | differential target multiplexed spinal cord stimulation in patients with persistent spinal pain syndrome type ii a study protocol for a 12 month multicentre cohort study detect |
| url | https://bmjopen.bmj.com/content/14/11/e083610.full |
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