Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimul… (NCT02052271) | Clinical Trial Compass
CompletedNot Applicable
Experimental Therapeutics in Essential Tremor Using Cerebellar Transcranial Direct Current Stimulation
France16 participantsStarted 2014-06-03
Plain-language summary
The purpose of this study is to determine whether transcranial cathodal direct current stimulation (tDCS) delivered over the cerebellum can improve essential tremor.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in tremor amplitude on clinical rating scale
Timeframe: 10 minutes after the end of tDCS
Trial details
NCT IDNCT02052271
SponsorInstitut National de la Santé Et de la Recherche Médicale, France