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

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

Status: Completed

Conditions: Essential Tremor

Treatments: Device: Cathodal cerebellar transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02052271

C13-24

2013-A01404-41 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Essential tremor

Experimental group

Description:

cerebellar stimulation

Treatment:

Device: Cathodal cerebellar transcranial direct current stimulation

Placebo arm

Placebo Comparator group

Description:

placebo stimulation

Treatment:

Device: Cathodal cerebellar transcranial direct current stimulation