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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Essential Tremor	Device: transcranial direct current stimulation	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
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.
Study Start Date :	April 2012
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	April 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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;

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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 ]
2. 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 ]
3. 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 ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 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