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tSMS in Essential Tremor

Primary Purpose

Essential Tremor

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
tSMS
sham
Sponsored by
Fundación de investigación HM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Essential tremor

Exclusion Criteria:

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

Sites / Locations

  • CINAC, Hospital Universitario Puerta del Sur

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

tSMS left motor cortex (sham right)

tSMS right motor cortex (sham left)

Arm Description

30 min of tSMS applied to the left motor cortex with sham on the right motor cortex

30 min of tSMS applied to the right motor cortex with sham on the left motor cortex

Outcomes

Primary Outcome 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.

Secondary Outcome Measures

Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
Change from baseline in rest tremor amplitude, as measured by accelerometry.
Change from baseline in tremor frequency, as measured by accelerometry.
Change from baseline in the Clinical Rating Scale for Tremor part B (drawing)

Full Information

First Posted
December 17, 2018
Last Updated
June 3, 2022
Sponsor
Fundación de investigación HM
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1. Study Identification

Unique Protocol Identification Number
NCT03780426
Brief Title
tSMS in Essential Tremor
Official Title
Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación de investigación HM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tSMS left motor cortex (sham right)
Arm Type
Experimental
Arm Description
30 min of tSMS applied to the left motor cortex with sham on the right motor cortex
Arm Title
tSMS right motor cortex (sham left)
Arm Type
Experimental
Arm Description
30 min of tSMS applied to the right motor cortex with sham on the left motor cortex
Intervention Type
Device
Intervention Name(s)
tSMS
Other Intervention Name(s)
MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain)
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
sham
Other Intervention Name(s)
MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry.
Time Frame
15 minutes after treatment compared to baseline
Title
Change from baseline in rest tremor amplitude, as measured by accelerometry.
Time Frame
Immediately after treatment and 15 minutes after treatment compared baseline.
Title
Change from baseline in tremor frequency, as measured by accelerometry.
Time Frame
Immediately after treatment and 15 minutes after treatment compared baseline.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Essential tremor Exclusion Criteria: MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) other main neuropsychiatric co-morbidity pregnancy
Facility Information:
Facility Name
CINAC, Hospital Universitario Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21807616
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.
Results Reference
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PubMed Identifier
25595064
Citation
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.
Results Reference
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PubMed Identifier
29500043
Citation
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.
Results Reference
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tSMS in Essential Tremor

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