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

Not Applicable

• Conditions: G25.0; Essential tremor

• Registration Number: DRKS00007959
• Lead Sponsor: Department of Neurology, University Hospital of Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 25

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;

Study & Design

• Study Type: interventional
• Study Design: Not specified