tSMS in Essential Tremor

Essential Tremor Clinical Trial

Official title:

Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03780426
• Other study ID #: Fundacion de Investigación HM
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

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