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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area

Intervention Type 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).

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).

Intervention Type DEVICE

Other Intervention Names

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MAGsv1.1 with MAG60r, Neurek SL, Toledo, Spain

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación de investigación HM

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Foffani

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Guglielmo Foffani, PhD

Role: CONTACT

+34 - 91 26 73 201

Facility Contacts

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Guglielmo Foffani, PhD

Role: primary

+34 - 91 26 73 201

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.

Reference Type BACKGROUND
PMID: 21807616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24125470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25595064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28659614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29500043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31701026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35609815 (View on PubMed)

Other Identifiers

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1715-GHM

Identifier Type: -

Identifier Source: org_study_id

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