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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
History of Changes
  Purpose

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.


Condition Intervention
Essential Tremor
 Device: transcranial direct current stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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.

Resource links provided by NLM:

MedlinePlus related topics: Tremor
U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 12
Study Start Date: April 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Therapeutic tDCS
6 patients with 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: Physiopathological tDCS
6 patients with 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;

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579435

Locations
France
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière
Paris, France, 75651
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Emmanuel Flamand-Roze, MD Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01579435     History of Changes
Other Study ID Numbers: C11-37, 2011-A01453-38
Study First Received: April 5, 2012
Last Updated: April 10, 2013
Health Authority: France: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
essential tremor
primary motor cortex
cerebellum
transcranial direct current stimulation
electrophysiology

Additional relevant MeSH terms:
Essential Tremor
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 27, 2015