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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579435
First Posted: April 18, 2012
Last Update Posted: April 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

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 ]
  • 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 ]
  • 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 ]

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

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Registry Identifier: IDRCB )
First Submitted: April 5, 2012
First Posted: April 18, 2012
Last Update Posted: April 11, 2013
Last Verified: April 2013

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:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases