Experimental Therapeutics in Essential Tremor Using Cereb... | NCT02052271

Studies
Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

NCT02052271

Sponsor

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

Status

Completed

Last Update Posted

Apr 24, 2026Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Essential Tremor

Interventions

Cathodal cerebellar transcranial direct current placebo stimulation
Cathodal cerebellar transcranial direct current active stimulation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2013-A01404-41	Registry Identifier	IDRCB

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2014Actual

Primary Completion Date

Mar 27, 2018Actual

Completion Date

Mar 27, 2018Actual

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Jan 30, 2014

First Posted Date

Feb 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 24, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Cathodal cerebellar transcranial direct current placebo stimulation	Device	Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;	Placebo arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in tremor amplitude on clinical rating scale		10 minutes after the end of tDCS

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Flamand-Roze, MD	Institut du Cerveau et de la Moelle et Fédération de Neurologie de l'Hôpital Pitié-Salpétrière, Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut du Cerveau et de la Moelle, Hôpital Pitié-Salpétrière		Paris		75651	France

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases