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

Primary Purpose

Essential Tremor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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 basic science trial for Essential Tremor focused on measuring essential tremor, primary motor cortex, cerebellum, transcranial direct current stimulation, electrophysiology

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Therapeutic tDCS

Physiopathological tDCS

Arm Description

6 patients with essential tremor

6 patients with essential tremor

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 accelerometric recording

Full Information

First Posted
April 5, 2012
Last Updated
April 10, 2013
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01579435
Brief Title
Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation
Acronym
ELECTRE
Official Title
Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic tDCS
Arm Type
Experimental
Arm Description
6 patients with essential tremor
Arm Title
Physiopathological tDCS
Arm Type
Experimental
Arm Description
6 patients with essential tremor
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;
Primary Outcome Measure Information:
Title
Change from baseline in tremor amplitude on accelerometric recording 10 minutes after the end of tDCS
Time Frame
10 minutes after the end of tDCS
Secondary Outcome Measure Information:
Title
Change from baseline in tremor amplitude on electromyographic recordings
Time Frame
During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Title
Change from baseline in tremor amplitude on digitized tablet
Time Frame
During tDCS (expected average of 15 minutes), 10 and 60 mn after the end of tDCS
Title
Change from baseline in tremor amplitude on accelerometric recording
Time Frame
During tDCS (expected average of 15 minutes) and 60 minutes after the end of tDCS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Transcranial Direct Current Stimulation

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