Clinical trial NCT02052271: Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation
Official title: Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: essential tremor
cerebellum
transcranial direct current stimulation
electrophysiology
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2014-02-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in tremor amplitude on clinical rating scale
timeFrame: 10 minutes after the end of tDCS
Secondary outcomes:
measure: Change from baseline in tremor amplitude on accelerometric recording
timeFrame: During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
measure: Change from baseline in tremor amplitude on electromyographic recordings
timeFrame: During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
measure: Change from baseline in tremor amplitude on digitized tablet
timeFrame: During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
measure: Change from baseline in tremor amplitude on clinical rating scale
timeFrame: During tDCS, 60 mn and 90 mn after the end of tDCS
measure: Change from baseline of amplitude of motor evoked potentials elicited by TMS
timeFrame: 10 mn, 60 mn and 90 mn after tDCS
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière
Study officials:
affiliation: Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
name: Emmanuel Flamand-Roze, MD
role: PRINCIPAL_INVESTIGATOR
References: