Experimental Therapeutics in Essential Tremor Using Cerebellar 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 cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.

Official Title
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Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux

Conditions
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Essential Tremor

Intervention / Treatment
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* Device: Cathodal cerebellar transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 65 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 mini-mental status score >24 Exclusion Criteria: Age < 18 years and > 65 years 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, loss of conciousness or current active epilepsy Contraindication for MRI or TMS study Intake of antiepileptic medications for essential tremor (barbiturates, gabapentine, topiramate, clonazepam), within the 7 days preceeding the first visit alcohol intake within the 24 hours preceeding the first visit 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: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Essential tremor<br>cerebellar stimulation | Device: Cathodal cerebellar transcranial direct current stimulation<br>* Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;<br>|
| Placebo Comparator: Placebo arm<br>placebo stimulation | Device: Cathodal cerebellar transcranial direct current stimulation<br>* Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation 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 clinical rating scale |  | 10 minutes after the end of tDCS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in tremor amplitude on accelerometric recording |  | During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS | 
| Change from baseline in tremor amplitude on electromyographic recordings |  | During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS | 
| Change from baseline in tremor amplitude on digitized tablet |  | During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS | 
| Change from baseline in tremor amplitude on clinical rating scale |  | During tDCS, 60 mn and 90 mn after the end of tDCS | 
| Change from baseline of amplitude of motor evoked potentials elicited by TMS |  | 10 mn, 60 mn and 90 mn after tDCS | 

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