Clinical trial NCT06840678: Home-based Transcranial Static Magnetic Field Stimulation (tSMS) of the Supplementary Motor Area in Parkinson's Disease
Official title: Patogénesis Cortical De La Enfermedad De Parkinson: Efectos Corticales Y Corticoestriatales De La Estimulación Transcraneal Por Campo Magnético Estático En Pacientes Con Enfermedad De Parkinson
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: Fundación de investigación HM
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* idiopathic Parkinson's disease (Brain Bank criteria)
* optimal clinical response to dopaminergic medication (\>30% MDS-UPDRS-III improvement)

Exclusion Criteria:

* MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
* presence of levodopa-induced dyskinesias
* other main neuropsychiatric co-morbidity

Primary outcomes:
measure: Adverse events (safety)
timeFrame: From the start to 3 months after the end of treatment (5 months)
measure: Feasibility of home-based tSMS
timeFrame: From the start to the end of treatment (8 weeks)
Secondary outcomes:
measure: Subjective improvement
timeFrame: Within one week after the end of treatment compared to baseline
measure: Motor improvement
timeFrame: Within one week after the end of treatment compared to baseline
measure: Sleep improvement
timeFrame: Within one week after the end of treatment compared to baseline
Other outcomes:
measure: Change in corticospinal excitability
timeFrame: Within one week after the end of treatment compared to baseline
measure: Changes in corticostriatal activity by FDG-PET
timeFrame: Within one week after the end of treatment compared to baseline
measure: Changes in corticostriatal activity by resting-state fMRI
timeFrame: Within one week after the end of treatment compared to baseline
measure: Changes in corticostriatal microstructure by diffusion-tensor imaging (DTI)
timeFrame: Within one week after the end of treatment compared to baseline
Locations:
city: Móstoles
country: Spain
facility: HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales
state: Madrid
Study officials:
affiliation: HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales, Móstoles, Madrid, Spain
name: Guglielmo Foffani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.