tSMS in Essential Tremor

Overview

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.

Full Title of Study: “Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 1, 2019

Interventions

  • Device: tSMS
    • 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).
  • Device: sham
    • 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.

Arms, Groups and Cohorts

  • Experimental: tSMS left motor cortex (sham right)
    • 30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
  • Experimental: tSMS right motor cortex (sham left)
    • 30 min of tSMS applied to the right motor cortex with sham on the left motor cortex

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
    • Time Frame: 15 minutes after treatment compared to baseline
  • Change from baseline in rest tremor amplitude, as measured by accelerometry.
    • Time Frame: Immediately after treatment and 15 minutes after treatment compared baseline.
  • Change from baseline in tremor frequency, as measured by accelerometry.
    • Time Frame: Immediately after treatment and 15 minutes after treatment compared baseline.
  • Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)
    • Time Frame: 5 minutes after treatment and 20 minutes after treatment compared to baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Essential tremor Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación de investigación HM
  • Provider of Information About this Clinical Study
    • Sponsor

References

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.

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.

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.

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