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Completed

NCT Number: NCT01579435

Experimental Therapeutics in Essential Tremor Using Transcranial Direct Current Stimulation

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.

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Movement Disorders Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75651, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Official study title

Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Trans-crânienne Par Courant Direct (tDCS) du Cortex cérébelleux et du Cortex Moteur. Etude Exploratoire.

Acronym: ELECTRE

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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