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This is a pilot open study to test the hypothesis that home-based transcranial static magnetic field stimulation (tSMS) of the supplementary motor area is safe and feasible to modulate corticostriatal activity in patients with Parkinson's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tSMS | Experimental | 30 min of tSMS, 5 daily sessions per week (monday to friday), for 8 weeks, at home |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (safety) | Number of device-related AE | From the start to 3 months after the end of treatment (5 months) |
| Feasibility of home-based tSMS | Number of home-based tSMS sessions completed, according to patient's diaries | From the start to the end of treatment (8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective improvement | Patient global impression of change (PGIC) | Within one week after the end of treatment compared to baseline |
| Motor improvement | MDS-UDPRS III scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in corticospinal excitability | Amplitude of motor evoked potentials (MEPs) evoked by transcranial magnetic stimulation of the motor cortex | Within one week after the end of treatment compared to baseline |
| Changes in corticostriatal activity by FDG-PET |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guglielmo Foffani, PhD | Contact | +34 - 91 26 73 201 | gfoffani.hmcinac@hmhospitales.com |
| Name | Affiliation | Role |
|---|---|---|
| Guglielmo Foffani, PhD | HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales, Móstoles, Madrid, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales | Recruiting | Móstoles | Madrid | 28938 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21807616 | Background | 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. | |
| 24125470 | Background | 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. |
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| Within one week after the end of treatment compared to baseline |
| Sleep improvement | SCOPA-sleep scale | Within one week after the end of treatment compared to baseline |
FDG-PET uptake in SMA and motor striatum
| Within one week after the end of treatment compared to baseline |
| Changes in corticostriatal activity by resting-state fMRI | Functional connectivity between SMA and motor striatum | Within one week after the end of treatment compared to baseline |
| Changes in corticostriatal microstructure by diffusion-tensor imaging (DTI) | Fractional anisotropy and diffusivity in SMA and motor striatum. | Within one week after the end of treatment compared to baseline |
| 25595064 | Background | 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. |
| 28659614 | Background | 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. |
| 29500043 | Background | 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. |
| 31701026 | Background | 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. |
| 35609815 | Background | 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. |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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