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Parkinson's DiseasePhase 1NCT06840678

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

A Phase 1 study testing Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area in people with Parkinson's Disease, run by Fundación de investigación HM at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson's Disease
What is being tested?
Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSpain
Study dates
1 Oct 2022to 31 Aug 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Guglielmo Foffani, PhD contact

+34 - 91 26 73 201

gfoffani.hmcinac@hmhospitales.com

Spain1 site, 1 recruiting

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

    Móstoles, Madrid, 28938

    Guglielmo Foffani, PhD, +34 - 91 26 73 201, gfoffani.hmcinac@hmhospitales.com

    Recruiting

Other trials in Spain

About this study

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

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.

Being tested
Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

    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).

Study groups in NCT06840678
Study groupRoleWhat they receive
tSMSExperimental30 min of tSMS, 5 daily sessions per week (monday to friday), for 8 weeks, at home
Receives: Device: Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (safety)

    Number of device-related AE

    Measured: From the start to 3 months after the end of treatment (5 months)

  2. Feasibility of home-based tSMS

    Number of home-based tSMS sessions completed, according to patient's diaries

    Measured: From the start to the end of treatment (8 weeks)

Secondary outcomes (3)

  1. Subjective improvement

    Patient global impression of change (PGIC)

    Measured: Within one week after the end of treatment compared to baseline

  2. Motor improvement

    MDS-UDPRS III scale

    Measured: Within one week after the end of treatment compared to baseline

  3. Sleep improvement

    SCOPA-sleep scale

    Measured: Within one week after the end of treatment compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start1 Oct 2022
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06840678
Sponsor's protocol ID
1715-GHM
Status last verified
Apr 2024
First submitted
12 Dec 2022
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21807616

  • 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.

    PubMed 24125470

  • 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.

    PubMed 25595064

  • 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.

    PubMed 28659614

  • 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.

    PubMed 29500043

  • 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.

    PubMed 31701026

  • 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.

    PubMed 35609815

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Transcranial static magnetic field stimulation (tSMS) of the supplementary motor area in people with Parkinson's Disease, run by Fundación de investigación HM at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guglielmo Foffani, PhD (+34 - 91 26 73 201, gfoffani.hmcinac@hmhospitales.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (safety) (time frame: From the start to 3 months after the end of treatment (5 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06840678, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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