Home-based Transcranial Static Magnetic Field Stimulation (tSMS) of the Supplementary Motor Area in Parkinson's Disease

NCT06840678 | Recruiting Phase 1

• 1 other identifier: 1715-GHM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Subjective improvement

  Within one week after the end of treatment compared to baseline

• Motor improvement

  Within one week after the end of treatment compared to baseline

• Sleep improvement

  Within one week after the end of treatment compared to baseline

Other Outcomes (4)

• Change in corticospinal excitability

  Within one week after the end of treatment compared to baseline

• Changes in corticostriatal activity by FDG-PET

  Within one week after the end of treatment compared to baseline

• Changes in corticostriatal activity by resting-state fMRI

  Within one week after the end of treatment compared to baseline

Study Arms (1)

tSMS

EXPERIMENTAL

30 min of tSMS, 5 daily sessions per week (monday to friday), for 8 weeks, at home

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

Interventions

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).

Also known as: MAGsv1.1 with MAG60r, Neurek SL, Toledo, Spain

tSMS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación de investigación HM: lead

Study Sites (1)

HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales

Móstoles, Madrid, 28938, Spain

RECRUITING

Related Publications (7)

• 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.

  PMID: 21807616 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.

  PMID: 24125470 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.

  PMID: 25595064 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.

  PMID: 28659614 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.

  PMID: 29500043 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.

  PMID: 31701026 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.

  PMID: 35609815 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Guglielmo Foffani, PhD

  HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales, Móstoles, Madrid, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guglielmo Foffani, PhD

CONTACT

+34 - 91 26 73 201; gfoffani.hmcinac@hmhospitales.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: February 21, 2025
• Study Start: October 1, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: February 21, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)