Essential Tremor | Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation
Essential Tremor research study
What is the primary objective of this study?
The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Cathodal cerebellar transcranial direct current stimulationActive stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Essential tremor30 patients with essential tremor
Start Date: May 2014
Completed Date: November 2018
Primary Outcome: Change from baseline in tremor amplitude on clinical rating scale
Secondary Outcome: Change from baseline in tremor amplitude on accelerometric recording
Study sponsors, principal investigator, and references
Principal Investigator: Emmanuel Flamand-Roze, MD
Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France