G25.0
Conditions
Interventions
Group 1: ET-patients before Deep Brain Stimulation electrode placement - pre-DBS
Group 2: Age- and gender-matched control subjects
Group 3: ET-patients receiving effective Deep Brain Stimulation (90-1
Sponsors
Department of Neurology, University Hospital of Cologne
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: ET-patients: Male or female patients with the clinical diagnosis of essential tremor according to the Consensus statement of the Movement Disorder Society on Tremor; ET-Patients aged between 50-75 years; Disease duration of more than 5 years; Capacity for consent so that written informed consent can be achieved; ET-Patients with a formal indication to a treatment with Deep Brain Stimulation (DBS) due to a therapy-refractory manifestation on at least three different pharmaceutical options and with the indication to electrode placement in the ventrolateral thalamus (VLp/Vim); Tolerable tremor severity after switching off the stimulation (DBS-OFF) Control subjects: Subjects aged between 50-75 years; Capacity for consent so that written informed consent can be achieved
Exclusion criteria
Exclusion criteria: ET-patients: Persons without capacity for consent, minors as well as individuals who are accomodated in an institution due to official or legal regulations; ET-patients suffering from other conditions (e.g. Alzheimer's disease, dystonia, epilepsy) besides essential tremor; ET-pateints with presence of unambiguous unilateral symptoms or hypokinesia; Unilateral dopaminergic deficit in functional imaging (FP-CIT SPECT); ET-patients with a significant response of symptoms after oral administration of levodopa, Irregularities in previous MRI scans (such as e.g. cerebral ischaemia, cerebellar atrophy, head surgery, etc.); Excessive head tremor hampering lying on the back over 90 minutes; Presence of symptomatic tremor causes such as metabolic or psychogenic tremor or due to the intake of tremor facilitating substances/drugs respectively as a consequence of their withdrawal; Presence of life-threatening diseases; Severe psychiatric comorbidities; Pregnant or breastfeeding women; Visual or hearing impairment interfering in the testing; ET-patients taking part in other interventional studies; Control subjects: Persons without capacity for consent, minors as well as individuals who are accomodated in an institution due to official or legal regulations; Subjects suffering from severe neurological disorders; Subjects with a regular intake of drugs interfering with the central nervous system which cannot be discontinued from the evening of the day before the testing until after testing is completed; Presence of life-threatening diseases; Severe psychiatric comorbidities; Pregnant or breastfeeding women; visual or hearing impairment interfering in the testing; Control subjects taking part in other interventional studies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PET of the regional blood flow in the tremor network (consisting of distinct brain areas) immeaditely after injection of radioactive tracer | — |
Secondary
| Measure | Time frame |
|---|---|
| Tremor Rating Scale (TRS), standardised value for phonemic verbal fluency scores | — |
Countries
Germany
Contacts
Public ContactDavid J. Pedrosa
Universitätsklinik Köln Klinik und Poliklinik für Neurologie AG Bewegungsstörungen
Outcome results
None listed