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

Tracking Information

First Received Date ^ICMJE

April 5, 2012

Last Updated Date

April 10, 2013

Start Date ^ICMJE

April 2012

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01579435 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

Official Title ^ICMJE

Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Essential Tremor

Intervention ^ICMJE

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;

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2013

Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01579435

Other Study ID Numbers ^ICMJE

C11-37, 2011-A01453-38

Has Data Monitoring Committee

Yes

Responsible Party

Institut National de la Santé Et de la Recherche Médicale, France

Study Sponsor ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Emmanuel Flamand-Roze, MD

Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris

Information Provided By

Institut National de la Santé Et de la Recherche Médicale, France

Verification Date

April 2013

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

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