Trial record 7 of 26 for:    Open Studies | "Essential Tremor"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Institut National de la Santé Et de la Recherche Médicale, France
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT02052271
First received: January 28, 2014
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Essential Tremor
Device: Cathodal cerebellar transcranial direct current stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Official Title: Thérapeutique expérimentale du Tremblement Essentiel Par la Stimulation Transcranienne Par Courant Direct (tDCS) du Cortex Cerebelleux

Resource links provided by NLM:


Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:
  • Change from baseline in tremor amplitude on clinical rating scale [ Time Frame: 10 minutes after the end of tDCS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in tremor amplitude on clinical rating scale [ Time Frame: During tDCS, 60 mn and 90 mn after the end of tDCS ] [ Designated as safety issue: No ]
  • Change from baseline of amplitude of motor evoked potentials elicited by TMS [ Time Frame: 10 mn, 60 mn and 90 mn after tDCS ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Essential tremor
30 patients with essential tremor
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;

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02052271

Contacts
Contact: Emmanuelle Apartis, MD, PhD +33(0)1 49 28 23 07 emmanuelle.apartis@sat.aphp.fr

Locations
France
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière Not yet recruiting
Paris, France, 75651
Principal Investigator: Emmanuel FLAMAND-ROZE         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Emmanuel Flamand-Roze, MD Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris
  More Information

No publications provided

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02052271     History of Changes
Other Study ID Numbers: C13-24, 2013-A01404-41
Study First Received: January 28, 2014
Last Updated: January 30, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
essential tremor
cerebellum
transcranial direct current stimulation
electrophysiology

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on July 31, 2014