Home-based Transcranial Static Magnetic Field Stimulation (tSMS) of the Supplementary Motor Area in Parkinson's Disease
NCT ID: NCT06840678
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2022-10-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tSMS
30 min of tSMS, 5 daily sessions per week (monday to friday), for 8 weeks, at home
Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. The investigators will use a cylindrical neodymium magnet of 60 mm diameter and 30 mm of thickness (MAG60r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the supplementary motor area (SMA) using an ergonomic helmet (MAGsv1.1, Neurek SL, Toledo, Spain).
Interventions
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Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area
Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. The investigators will use a cylindrical neodymium magnet of 60 mm diameter and 30 mm of thickness (MAG60r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the supplementary motor area (SMA) using an ergonomic helmet (MAGsv1.1, Neurek SL, Toledo, Spain).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* optimal clinical response to dopaminergic medication (\>30% MDS-UPDRS-III improvement)
Exclusion Criteria
* presence of levodopa-induced dyskinesias
* other main neuropsychiatric co-morbidity
18 Years
80 Years
ALL
No
Sponsors
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Fundación de investigación HM
OTHER
Responsible Party
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Guglielmo Foffani
PhD
Principal Investigators
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Guglielmo Foffani, PhD
Role: PRINCIPAL_INVESTIGATOR
HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales, Móstoles, Madrid, Spain
Locations
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HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales
Móstoles, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Oliviero A, Mordillo-Mateos L, Arias P, Panyavin I, Foffani G, Aguilar J. Transcranial static magnetic field stimulation of the human motor cortex. J Physiol. 2011 Oct 15;589(Pt 20):4949-58. doi: 10.1113/jphysiol.2011.211953. Epub 2011 Aug 1.
Rivadulla C, Foffani G, Oliviero A. Magnetic field strength and reproducibility of neodymium magnets useful for transcranial static magnetic field stimulation of the human cortex. Neuromodulation. 2014 Jul;17(5):438-41; discussion 441-2. doi: 10.1111/ner.12125. Epub 2013 Oct 11.
Oliviero A, Carrasco-Lopez MC, Campolo M, Perez-Borrego YA, Soto-Leon V, Gonzalez-Rosa JJ, Higuero AM, Strange BA, Abad-Rodriguez J, Foffani G. Safety Study of Transcranial Static Magnetic Field Stimulation (tSMS) of the Human Cortex. Brain Stimul. 2015 May-Jun;8(3):481-5. doi: 10.1016/j.brs.2014.12.002. Epub 2014 Dec 11.
Dileone M, Carrasco-Lopez MC, Segundo-Rodriguez JC, Mordillo-Mateos L, Lopez-Ariztegui N, Alonso-Frech F, Catalan-Alonso MJ, Obeso JA, Oliviero A, Foffani G. Dopamine-dependent changes of cortical excitability induced by transcranial static magnetic field stimulation in Parkinson's disease. Sci Rep. 2017 Jun 28;7(1):4329. doi: 10.1038/s41598-017-04254-y.
Dileone M, Mordillo-Mateos L, Oliviero A, Foffani G. Long-lasting effects of transcranial static magnetic field stimulation on motor cortex excitability. Brain Stimul. 2018 Jul-Aug;11(4):676-688. doi: 10.1016/j.brs.2018.02.005. Epub 2018 Feb 7.
Pineda-Pardo JA, Obeso I, Guida P, Dileone M, Strange BA, Obeso JA, Oliviero A, Foffani G. Static magnetic field stimulation of the supplementary motor area modulates resting-state activity and motor behavior. Commun Biol. 2019 Oct 31;2:397. doi: 10.1038/s42003-019-0643-8. eCollection 2019.
Dileone M, Ammann C, Catanzaro V, Pagge C, Piredda R, Monje MHG, Navalpotro-Gomez I, Bergareche A, Rodriguez-Oroz MC, Vela-Desojo L, Alonso-Frech F, Catalan MJ, Molina JA, Lopez-Ariztegu N, Oliviero A, Obeso JA, Foffani G. Home-based transcranial static magnetic field stimulation of the motor cortex for treating levodopa-induced dyskinesias in Parkinson's disease: A randomized controlled trial. Brain Stimul. 2022 May-Jun;15(3):857-860. doi: 10.1016/j.brs.2022.05.012. Epub 2022 May 21. No abstract available.
Other Identifiers
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1715-GHM
Identifier Type: -
Identifier Source: org_study_id
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