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Completed

NCT Number: NCT03780426

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CINAC, Hospital Universitario Puerta del Sur

Móstoles, Madrid, 28938, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Essential tremor

Exclusion criteria

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

Treatment and study plan

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).

Other names: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)

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.

Other names: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

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.

    Time frame: Immediately after treatment compared baseline

Secondary outcomes

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

    Time frame: 15 minutes after treatment compared to baseline

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

    Time frame: Immediately after treatment and 15 minutes after treatment compared baseline.

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

    Time frame: Immediately after treatment and 15 minutes after treatment compared baseline.

  4. 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

Sponsors and collaborators

Lead sponsor

Fundación de investigación HM

Other

Registry information

Official study title

Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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