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

Primary Purpose

Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cathodal cerebellar transcranial direct current stimulation
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Essential Tremor focused on measuring essential tremor, cerebellum, transcranial direct current stimulation, electrophysiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Essential tremor

Placebo arm

Arm Description

cerebellar stimulation

placebo stimulation

Outcomes

Primary Outcome Measures

Change from baseline in tremor amplitude on clinical rating scale

Secondary Outcome Measures

Change from baseline in tremor amplitude on accelerometric recording
Change from baseline in tremor amplitude on electromyographic recordings
Change from baseline in tremor amplitude on digitized tablet
Change from baseline in tremor amplitude on clinical rating scale
Change from baseline of amplitude of motor evoked potentials elicited by TMS

Full Information

First Posted
January 28, 2014
Last Updated
February 11, 2020
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02052271
Brief Title
Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation
Acronym
ELECTRE2
Official Title
Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2014 (Actual)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor
Keywords
essential tremor, cerebellum, transcranial direct current stimulation, electrophysiology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Essential tremor
Arm Type
Experimental
Arm Description
cerebellar stimulation
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
placebo stimulation
Intervention Type
Device
Intervention Name(s)
Cathodal cerebellar transcranial direct current stimulation
Intervention Description
Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
Primary Outcome Measure Information:
Title
Change from baseline in tremor amplitude on clinical rating scale
Time Frame
10 minutes after the end of tDCS
Secondary Outcome Measure Information:
Title
Change from baseline in tremor amplitude on accelerometric recording
Time Frame
During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Title
Change from baseline in tremor amplitude on electromyographic recordings
Time Frame
During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Title
Change from baseline in tremor amplitude on digitized tablet
Time Frame
During tDCS, 10 mn, 60 mn and 90 mn after the end of tDCS
Title
Change from baseline in tremor amplitude on clinical rating scale
Time Frame
During tDCS, 60 mn and 90 mn after the end of tDCS
Title
Change from baseline of amplitude of motor evoked potentials elicited by TMS
Time Frame
10 mn, 60 mn and 90 mn after tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel Flamand-Roze, MD
Organizational Affiliation
Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75651
Country
France

12. IPD Sharing Statement

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Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

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