Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation (ELECTRE)
This study is currently recruiting participants.
Verified April 2012 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
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 16, 2012
Last verified: April 2012
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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
familial paroxysmal nonkinesigenic dyskinesia
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 ]
Estimated Enrollment: | 12 |
Study Start Date: | April 2012 |
Estimated Study Completion Date: | October 2013 |
Estimated 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;
|
![](https://webarchive.library.unt.edu/web/20121018215628im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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
![](https://webarchive.library.unt.edu/web/20121018215628im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01579435
Contacts
Contact: Emmanuelle Apartis, MD,PhD | +33(0)1 49 28 23 07 | emmanuelle.apartis@sat.aphp.fr |
Locations
France | |
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière | Recruiting |
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 |
![](https://webarchive.library.unt.edu/web/20121018215628im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
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 16, 2012 |
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 October 17, 2012