Functional imaging of regional blood flow changes within the tremor network due to Deep Brain Stimulation in the ventrolateral thalamus with H2O-PET - ColTrem II

Department of Neurology, University Hospital of Cologne0 sites25 target enrollmentApril 7, 2015

ConditionsG25.0 Essential tremor

Overview

Phase: 未知
Intervention: Not specified
Conditions: G25.0
Sponsor: Department of Neurology, University Hospital of Cologne
Enrollment: 25
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 7, 2015

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Department of Neurology, University Hospital of Cologne

Eligibility 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

•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;