Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

Not Applicable

Completed

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

• Registration Number: NCT02052271
• 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 cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-30
• Study First Posted: 2014-02-03
• Study Start: 2014-06-03
• Primary Completion: 2018-03-27
• Study Completion: 2018-03-27
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Essential tremor	Cathodal cerebellar transcranial direct current stimulation	cerebellar stimulation
Placebo arm	Cathodal cerebellar transcranial direct current stimulation	placebo stimulation

Primary Outcome Measures

Name	Time	Method
Change from baseline in tremor amplitude on clinical rating scale	10 minutes after the end of tDCS

Secondary Outcome Measures

Name	Time	Method
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 digitized tablet	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 of amplitude of motor evoked potentials elicited by TMS	10 mn, 60 mn and 90 mn after tDCS
Change from baseline in tremor amplitude on clinical rating scale	During tDCS, 60 mn and 90 mn after the end of tDCS

Trial Locations

Locations (1)

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