tSMS in Essential Tremor

June 3, 2022 updated by: Fundación de investigación HM

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Móstoles, Madrid, Spain, 28938
        • CINAC, Hospital Universitario Puerta del Sur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Essential tremor

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tSMS left motor cortex (sham right)
30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
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).
Other Names:
  • MAGmv1.0 with MAG45r, Neurek S.L. (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.
Other Names:
  • MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
Experimental: tSMS right motor cortex (sham left)
30 min of tSMS applied to the right motor cortex with sham on the left motor cortex
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).
Other Names:
  • MAGmv1.0 with MAG45r, Neurek S.L. (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.
Other Names:
  • MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Immediately after treatment compared baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
Time Frame: 15 minutes after treatment compared to baseline
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.
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.
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
5 minutes after treatment and 20 minutes after treatment compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de investigación HM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 17, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fundacion de Investigación HM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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