Participants and Recruitment

BS Bastian Elmar Alexander Sajonz
FA Florian Amtage
PR Peter Christoph Reinacher
CJ Carolin Jenkner
TP Tobias Piroth
JK Jürgen Kätzler
HU Horst Urbach
VC Volker Arnd Coenen
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We plan to recruit 24 male or female patients (12 per treatment group). Patients who are referred to our departments due to disabling medically resistant essential tremor are informed about this study. Patients who give their informed consent are registered in the trial and undergo the screening. Patients who gave their informed consent but do not undergo stereotactic surgery are regarded as screening failures. See Textbox 1 for eligibility criteria.

Inclusion criteria:

Aged 25 to 80 years, inclusive

Essential tremor according to the criteria of the consensus statement of the Movement Disorder Society [17] with a medical treatment–resistant and disabling postural or intentional tremor

Stable tremor medication for at least 3 months prior to inclusion

An FTMTRS completed within 42 days prior to surgery

Written informed consent

Exclusion criteria:

Major depression

Dementia (Mattis Dementia Rating Scale [MDRS]≤130)

Acute psychosis

Known or persistent abuse of medication, drugs, or alcohol

Patient incapability

Nursing care at home

Surgical contraindications or medications that are likely to cause interactions in the opinion of the investigator

Persons who are in a relationship of dependence/employment with the sponsor or the investigator

Fertile women not using adequate contraceptive methods or with current or planned pregnancy or nursing period

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