Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation (ELECTRE)
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ClinicalTrials.gov Identifier: NCT01579435 |
Recruitment Status
:
Completed
First Posted
: April 18, 2012
Last Update Posted
: April 11, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Essential Tremor | Device: transcranial direct current stimulation | Not Applicable |
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 |

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;
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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;
|
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
France | |
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière | |
Paris, France, 75651 |
Principal Investigator: | Emmanuel Flamand-Roze, MD | Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris |
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 Key Record Dates |
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 |