Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation (ELECTRE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01579435
First received: April 5, 2012
Last updated: April 10, 2013
Last verified: April 2013

April 5, 2012
April 10, 2013
April 2012
April 2013   (final data collection date for primary outcome measure)
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS [ Time Frame: 10 minutes after the end of tDCS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01579435 on ClinicalTrials.gov Archive Site
  • Change from baseline in tremor amplitude on electromyographic recordings [ Time Frame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS ] [ Designated as safety issue: No ]
  • Change from baseline in tremor amplitude on digitized tablet [ Time Frame: During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS ] [ Designated as safety issue: No ]
  • Change from baseline in tremor amplitude on accelerometric recording [ Time Frame: During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Essential Tremor
Device: transcranial direct current stimulation
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;
  • Experimental: Therapeutic tDCS
    6 patients with essential tremor
    Intervention: Device: transcranial direct current stimulation
  • Experimental: Physiopathological tDCS
    6 patients with essential tremor
    Intervention: Device: transcranial direct current stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01579435
C11-37, 2011-A01453-38
Yes
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Principal Investigator: Emmanuel Flamand-Roze, MD Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
Institut National de la Santé Et de la Recherche Médicale, France
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP