DRKS00032400
Recruiting
未知
Optimization of Deep Brain Stimulation site and algorithm patterns for Essential Tremor - a randomized two arm pilot study - OPTI-ET
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- G25.0
- Sponsor
- niversitätsklinikum Freiburg
- Enrollment
- 24
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Not specified
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