Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation

NCT ID: NCT02052271

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-03
• Study Completion Date: 2018-03-27

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.

Conditions

Essential Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Essential tremor

cerebellar stimulation

Group Type: EXPERIMENTAL

Cathodal cerebellar transcranial direct current stimulation

Intervention Type: DEVICE

Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;

Placebo arm

placebo stimulation

Group Type: PLACEBO_COMPARATOR

Cathodal cerebellar transcranial direct current stimulation

Intervention Type: DEVICE

Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;

Interventions

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;

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Flamand-Roze, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Paris, , France

Countries

France

Other Identifiers

2013-A01404-41

Identifier Type: REGISTRY

Identifier Source: secondary_id

C13-24

Identifier Type: -

Identifier Source: org_study_id