Essential Tremor
Conditions
Keywords
essential tremor, cerebellum, transcranial direct current stimulation, electrophysiology
Brief summary
The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.
Interventions
Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
Active stimulation: duration: 20 mn, intensity: 2 mA; localisation cerebellum;
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in tremor amplitude on clinical rating scale | 10 minutes after the end of tDCS |
Secondary
| Measure | 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 |
Countries
France
Contacts
Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris