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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03780426
Other study ID # Fundacion de Investigación HM
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 1, 2018
Est. completion date December 1, 2019

Study information

Verified date June 2022
Source Fundación de investigación HM
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Essential tremor Exclusion Criteria: - MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) - other main neuropsychiatric co-morbidity - pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
Spain CINAC, Hospital Universitario Puerta del Sur Móstoles Madrid

Sponsors (1)

Lead Sponsor Collaborator
Fundación de investigación HM

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View Citation

Oliviero A, Carrasco-López MC, Campolo M, Perez-Borrego YA, Soto-León 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry. 15 minutes after treatment compared to baseline
Secondary Change from baseline in rest tremor amplitude, as measured by accelerometry. Immediately after treatment and 15 minutes after treatment compared baseline.
Secondary Change from baseline in tremor frequency, as measured by accelerometry. Immediately after treatment and 15 minutes after treatment compared baseline.
Secondary 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
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