DRKS00032400RecruitingUnknown
Optimization of Deep Brain Stimulation site and algorithm patterns for Essential Tremor - a randomized two arm pilot study - OPTI-ET
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- niversitätsklinikum Freiburg
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 21 Years to 85 Years (—)
- Sex
- All
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.)
Investigators
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