tSMS in Essential Tremor

Study Overview
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Brief Summary
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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.

Official Title
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Transcranial Static Magnetic Field Stimulation (tSMS) in Essential Tremor

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: tSMS
* Device: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Essential tremor Exclusion Criteria: MRI-incompatible metal objects in the body (e.g. cardiac pacemakers) other main neuropsychiatric co-morbidity pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tSMS left motor cortex (sham right)<br>30 min of tSMS applied to the left motor cortex with sham on the right motor cortex | Device: tSMS<br>* 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).<br>* Other names: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain);Device: sham<br>* 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.<br>* Other names: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain);|
| Experimental: tSMS right motor cortex (sham left)<br>30 min of tSMS applied to the right motor cortex with sham on the left motor cortex | Device: tSMS<br>* 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).<br>* Other names: MAGmv1.0 with MAG45r, Neurek S.L. (Toledo, Spain);Device: sham<br>* 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.<br>* Other names: MAGmv1.0 with MAG45s, Neurek S.L. (Toledo, Spain);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | Immediately after treatment compared baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in postural tremor amplitude 15 minutes after treatment, as measured by accelerometry. |  | 15 minutes after treatment compared to baseline | 
| Change from baseline in rest tremor amplitude, as measured by accelerometry. |  | Immediately after treatment and 15 minutes after treatment compared baseline. | 
| Change from baseline in tremor frequency, as measured by accelerometry. |  | Immediately after treatment and 15 minutes after treatment compared baseline. | 
| 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 |