Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

Essential Tremor Clinical Trial

— ELECTRE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579435
• Other study ID #: C11-37
• Secondary ID: 2011-A01453-38
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: April 10, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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;

Locations

Country	Name	City	State
France	Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS		10 minutes after the end of tDCS	No
Secondary	Change from baseline in tremor amplitude on electromyographic recordings		During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS	No
Secondary	Change from baseline in tremor amplitude on digitized tablet		During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS	No
Secondary	Change from baseline in tremor amplitude on accelerometric recording		During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS	No