Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

Essential Tremor Clinical Trial

— ELECTRE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052271
• Other study ID #: C13-24
• Secondary ID: 2013-A01404-41
• Status: Completed
• Phase: N/A
• Start date: June 3, 2014
• Est. completion date: March 27, 2018

Study information

• Verified date: February 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

Intervention

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;

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