Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

Not Applicable

Completed

• Conditions: Essential Tremor
• Interventions: Device: transcranial direct current stimulation

• Registration Number: NCT01579435
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic tDCS	transcranial direct current stimulation	6 patients with essential tremor
Physiopathological tDCS	transcranial direct current stimulation	6 patients with essential tremor

Primary Outcome Measures

Name	Time	Method
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS	10 minutes after the end of tDCS

Secondary Outcome Measures

Name	Time	Method
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
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
Change from baseline in tremor amplitude on accelerometric recording	During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS

Trial Locations

Locations (1)

Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière; 🇫🇷 Paris, France