NCT02052271

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

June 3, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

April 24, 2026

Status Verified

February 1, 2020

Enrollment Period

3.8 years

First QC Date

January 28, 2014

Last Update Submit

April 21, 2026

Conditions

Essential Tremor

Keywords

essential tremorcerebellumtranscranial direct current stimulationelectrophysiology

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in tremor amplitude on clinical rating scale

    10 minutes after the end of tDCS

Secondary Outcomes (5)

  • 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 electromyographic recordings

    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 clinical rating scale

    During tDCS, 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

Study Arms (2)

Essential tremor

EXPERIMENTAL

cerebellar stimulation

Device: Cathodal cerebellar transcranial direct current active stimulation

Placebo arm

PLACEBO COMPARATOR

placebo stimulation

Device: Cathodal cerebellar transcranial direct current placebo stimulation

Interventions

Cathodal cerebellar transcranial direct current placebo stimulationDEVICE

Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;

Placebo arm
Cathodal cerebellar transcranial direct current active stimulationDEVICE

Active stimulation: duration: 20 mn, intensity: 2 mA; localisation cerebellum;

Essential tremor

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75651, France

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Emmanuel Flamand-Roze, MD

    Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2014

First Posted

February 3, 2014

Study Start

June 3, 2014

Primary Completion

March 27, 2018

Study Completion

March 27, 2018

Last Updated

April 24, 2026

Record last verified: 2020-02

Locations

FR(1)