Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) delivered over the motor cortex or the cerebellum can improve essential tremor and to identify the cerebral mechanisms involved in these potential effects.

Official Title
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Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and < 50 years Important essential tremor (bilateral postural and/or action tremor since more than one year) Normal physical and neurological examination, except for essential tremor Insufficient efficiency of usual essential tremor's treatment No treatment altering the cortical excitability Agreement to use a medically acceptable method of contraception throughout the study for female of childbearing potential Exclusion Criteria: Cervical tremor Current neurological or psychiatric illness other than essential tremor Individual who is on medication which is known to lower seizure threshold Previous history of seizure(s), malaise or current active epilepsy Contraindication for MRI or TMS study Pregnancy, breast feeding women and women who are of childbearing age and not practicing adequate birth control Individual who have MMS ≤ 24/30 or patients legally protected or inability to provide an informed consent Simultaneous participation in another clinical trial Patients who are not enrolled at social security

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic tDCS<br>6 patients with essential tremor | Device: transcranial direct current stimulation<br>* Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;<br>|
| Experimental: Physiopathological tDCS<br>6 patients with essential tremor | Device: transcranial direct current stimulation<br>* Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS |  | 10 minutes after the end of tDCS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in tremor amplitude on electromyographic recordings |  | During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS | 
| Change from baseline in tremor amplitude on digitized tablet |  | During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS | 
| Change from baseline in tremor amplitude on accelerometric recording |  | During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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essential tremor, primary motor cortex, cerebellum, transcranial direct current stimulation, electrophysiology