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

February 19, 2025 updated by: Guglielmo Foffani, Fundación de investigación HM

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Madrid
      • Móstoles, Madrid, Spain, 28938
        • Recruiting
        • HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tSMS
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
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 Names:
  • MAGsv1.1 with MAG60r, Neurek SL, Toledo, Spain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (safety)
Time Frame: From the start to 3 months after the end of treatment (5 months)
Number of device-related AE
From the start to 3 months after the end of treatment (5 months)
Feasibility of home-based tSMS
Time Frame: From the start to the end of treatment (8 weeks)
Number of home-based tSMS sessions completed, according to patient's diaries
From the start to the end of treatment (8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective improvement
Time Frame: Within one week after the end of treatment compared to baseline
Patient global impression of change (PGIC)
Within one week after the end of treatment compared to baseline
Motor improvement
Time Frame: Within one week after the end of treatment compared to baseline
MDS-UDPRS III scale
Within one week after the end of treatment compared to baseline
Sleep improvement
Time Frame: Within one week after the end of treatment compared to baseline
SCOPA-sleep scale
Within one week after the end of treatment compared to baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in corticospinal excitability
Time Frame: Within one week after the end of treatment compared to baseline
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
Time Frame: 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
Time Frame: Within one week after the end of treatment compared to baseline
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)
Time Frame: Within one week after the end of treatment compared to baseline
Fractional anisotropy and diffusivity in SMA and motor striatum.
Within one week after the end of treatment compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de investigación HM

Investigators

  • Principal Investigator: Guglielmo Foffani, PhD, HM CINAC, Hospital Universitario HM Puerta del Sur, HM Hospitales, Móstoles, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 12, 2022

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1715-GHM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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