Clinical trial NCT01579435: Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
Official title: Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Keywords: essential tremor
primary motor cortex
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: 2012-04-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
timeFrame: 10 minutes after the end of tDCS
Secondary outcomes:
measure: Change from baseline in tremor amplitude on electromyographic recordings
timeFrame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
measure: Change from baseline in tremor amplitude on digitized tablet
timeFrame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
measure: Change from baseline in tremor amplitude on accelerometric recording
timeFrame: During tDCS (expected average of 15 minutes) and 60 minutes after the end of 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: