Transcranial Stimulation for Essential Tremor

Stopped early · Not applicable · Has a placebo group

Conditions studied: Essential Tremor

In brief

The main purpose of this study is to see if transcranial magnetic stimulation (TMS) can be used to help study brain function in healthy people and in those with neurological diseases like essential tremor. This portion of the study is being done to establish the optimal methods for stimulating the brain to measure its responses.

Key facts

Study ID

NCT03025529

Run by

Beth Israel Deaconess Medical Center

People needed

8

Starts

2015-02-01

Expected to finish

2016-11-28

Last updated by the study team

2017-12-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Any unstable illness or concomitant medical condition that, in the investigator's opinion, precludes participation in this study, including disorders that may affect gait or balance (i.e., stroke, arthritis, etc).
• Pregnancy or lactation.
• Concurrent participation in another clinical study.
• Dementia or other psychiatric illness that prevents the patient from giving informed consent (Montreal Cognitive Assessment Score score less than or equal to 21).
• Legal incapacity or limited legal capacity.
• Tremor derived from any cause other than essential tremor (Parkinson's disease, drug-induced, anxiety-induced) in the clinical assessment at screening
• Currently taking lithium or amiodarone or any other drug judged to be contributing to tremor as judged by the investigator (may be a cause of tremor)
• No medication is an absolute exclusion from TMS. Medications will be reviewed by the responsible MD and a decision about inclusion will be made based on the following:
• The patient's past medical history, drug dose, history of recent medication changes or duration of treatment, and combination with other Central Nervous System active drugs.
• The published TMS guidelines review of medications to be considered with TMS
• History of seizures, diagnosis of epilepsy, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgement of the investigator
• TMS and MRI-Specific exclusion criteria including:
• Known metal in the head (such as a surgical aneurysm clip) or a history of prior neurosurgical procedures.
• Ferromagnetic bioimplants activated by any electronic, mechanical or magnetic means, such as cochlear implants, pacemakers, medication pumps, vagal stimulators, deep brain stimulators, neurostimulators, biostimulators, or ventriculo-peritoneal shunts.
• Subjects who have or might have bullet fragments or other shrapnel (veterans or workers exposed to metal in their work environment).
• Subjects with metallic paint (e.g. color contact lenses, tattoos, metallic eyeliner)
• Subjects expressing significant claustrophobia.

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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