Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation (ELECTRE2)

Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux

The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.

Study Overview

• Status: Completed
• Conditions: Essential Tremor
• Intervention / Treatment: Device: Cathodal cerebellar transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75651
    • Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years and ≤ 65 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
• mini-mental status score >24

Exclusion Criteria:

• Age < 18 years and > 65 years
• 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, loss of conciousness or current active epilepsy
• Contraindication for MRI or TMS study
• Intake of antiepileptic medications for essential tremor (barbiturates, gabapentine, topiramate, clonazepam), within the 7 days preceeding the first visit
• alcohol intake within the 24 hours preceeding the first visit
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Essential tremor; cerebellar stimulation	Device: Cathodal cerebellar transcranial direct current stimulation; Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
Placebo Comparator: Placebo arm; placebo stimulation	Device: Cathodal cerebellar transcranial direct current stimulation; Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in tremor amplitude on clinical rating scale	10 minutes after the end of tDCS

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in tremor amplitude on accelerometric recording	During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Change from baseline in tremor amplitude on electromyographic recordings	During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Change from baseline in tremor amplitude on digitized tablet	During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Change from baseline in tremor amplitude on clinical rating scale	During tDCS, 60 mn and 90 mn after the end of tDCS
Change from baseline of amplitude of motor evoked potentials elicited by TMS	10 mn, 60 mn and 90 mn after tDCS

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2014
• Primary Completion (Actual): March 27, 2018
• Study Completion (Actual): March 27, 2018

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 30, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; essential tremor; cerebellum; electrophysiology
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Movement Disorders; Dyskinesias; Tremor; Essential Tremor
• Other Study ID Numbers: C13-24; 2013-A01404-41 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No