Optimization of Deep Brain Stimulation site and algorithm patterns for Essential Tremor - a randomized two arm pilot study - OPTI-ET

niversitätsklinikum Freiburg0 个研究点目标入组 24 人开始时间: 2023年7月31日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Male or female aged 21 years minimum and 85 years maximum on the day of experimental procedures
•2.Diagnosed with Essential Tremor (ET) affecting their hand(s)
•3.Patients with essential tremor who are eligible for Vim/DRT DBS Surgery according to the guidelines of the DGN (www.dgn.org) or patients with Essential Tremor and VIM/DRT-DBS implantation and undergoing replacement of their battery-depleted IPG
•4.Implanted with DBS lead(s) in the thalamic ViM/DRT region to treat ET and whose leads are temporarily externalized via extension cables. Lead(s) may be implanted initially (first time) or chronically (patient undergoing replacement of their battery-depleted IPG)
•5.For acute stimulation setting: Presence of tremor in the hand of grade 2 or more on a clinical rating scale with OFF medication/OFF stimulation state on the day of experiment. The tremor needs to be markedly reduced (++ improvement according to Coenen et al. 2020) by means of conventional tonic DBS, as determined by the Investigator
•6.Patients who have provided written informed consent

•1.For acute stimulation setting: Presence of factors that may make assessment of the tremor ambiguous on the day of the experiment (e.g. lead implantation stun effect, alcohol consumption), as determined by the Investigator
•For acute and chronic study:
•2.Imaging of the leads in relation to neural structures not available
•3.Dementia symptoms
•4.Pregnant or breastfeeding women
•5.Implanted with another active device (cardiac pacemaker etc.)

发起方