tSMS in Essential Tremor

NCT03780426 | Completed Phase 2

• 1 other identifier: Fundacion de Investigación HM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (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.

  Immediately after treatment compared baseline

Secondary Outcomes (4)

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

  15 minutes after treatment compared to baseline

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

  Immediately after treatment and 15 minutes after treatment compared baseline.

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

  Immediately after treatment and 15 minutes after treatment compared baseline.

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

  5 minutes after treatment and 20 minutes after treatment compared to baseline

Study Arms (2)

tSMS left motor cortex (sham right)

EXPERIMENTAL

30 min of tSMS applied to the left motor cortex with sham on the right motor cortex

Device: tSMS; Device: sham

tSMS right motor cortex (sham left)

EXPERIMENTAL

30 min of tSMS applied to the right motor cortex with sham on the left motor cortex

Device: tSMS; Device: sham

Interventions

tSMS DEVICE

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).

Also known as: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

tSMS left motor cortex (sham right); tSMS right motor cortex (sham left)

sham DEVICE

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.

Also known as: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

tSMS left motor cortex (sham right); tSMS right motor cortex (sham left)

Eligibility Criteria

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

You may qualify if:

• Essential tremor

You may not qualify if:

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

Sponsors & Collaborators

• Fundación de investigación HM: lead

Study Sites (1)

CINAC, Hospital Universitario Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

Related Publications (4)

• 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

• 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, 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

• 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.

  PMID: 41298510 DERIVED

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: October 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

ES (1)