Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation - Full Text View

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:

Genetics Home Reference related topics: essential tremor

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 (Adult)
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


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:


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

ClinicalTrials.gov processed this record on September 30, 2016

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