AzTrials
AzTrials

Essential TremorPhase 2NCT03780426

tSMS in Essential Tremor

A Phase 2 study testing tSMS in people with Essential Tremor, run by Fundación de investigación HM at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Essential Tremor
What is being tested?
tSMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteSpain
Study dates
1 Oct 2018to 1 Dec 2019
Phase
Phase 2
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

  • Essential tremor

Who cannot join

  • MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
  • other main neuropsychiatric co-morbidity
  • pregnancy

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • CINAC, Hospital Universitario Puerta del Sur

    Móstoles, Madrid, 28938

Other trials in Spain

About this study

Official title: Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor

This is randomized double-blind study to study the hypothesis that transcranial static magnetic field stimulation of the primary motor cortex improves tremor in patients with essential tremor. Half of the patients will receive tSMS of the left hemisphere and the other half of the right hemisphere.

Being tested
tSMS, sham
Medical subject headings
Essential Tremor

What participants receive

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

  • tSMSDevice

    Also called MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

    Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).

  • shamDevice

    Also called MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

    A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.

Study groups in NCT03780426
Study groupRoleWhat they receive
tSMS left motor cortex (sham right)Experimental30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
Receives: Device: tSMS; Device: sham
tSMS right motor cortex (sham left)Experimental30 min of tSMS applied to the right motor cortex with sham on the left motor cortex
Receives: Device: tSMS; Device: sham

What is being measured

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

  1. Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry.

    Measured: Immediately after treatment compared baseline

Secondary outcomes (4)

  1. Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.

    Measured: 15 minutes after treatment compared to baseline

  2. Change from baseline in rest tremor amplitude, as measured by accelerometry.

    Measured: Immediately after treatment and 15 minutes after treatment compared baseline.

  3. Change from baseline in tremor frequency, as measured by accelerometry.

    Measured: Immediately after treatment and 15 minutes after treatment compared baseline.

  4. Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)

    Measured: 5 minutes after treatment and 20 minutes after 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 posted19 Dec 2018
  2. Study start1 Oct 2018
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03780426
Sponsor's protocol ID
Fundacion de Investigación HM
Status last verified
Jun 2022
First submitted
17 Dec 2018
Last updated
6 Jun 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
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

  • 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, 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

  • Urso D, Monje MHG, Fernandez-Rodriguez B, Vela-Desojo L, Oliviero A, Foffani G, Ammann C. Transcranial static magnetic field stimulation of the primary motor cortex in essential tremor: a randomized pilot study. NPJ Parkinsons Dis. 2025 Nov 26;11(1):336. doi: 10.1038/s41531-025-01182-x.

    PubMed 41298510

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tSMS in people with Essential Tremor, 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 1 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: finished, as of the sponsor's last update on 6 Jun 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in postural tremor amplitude in the hand contralateral to hemispheren that received tSMS treatment compared to the hand contralateral to the hemisphere that received sham treatment, as measured by accelerometry. (time frame: Immediately after treatment compared baseline). 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 NCT03780426, which also lists 4 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 6 Jun 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in