Coordinated Reset Deep Brain Stimulation for Essential Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Deep brain stimulation.
- Who it may be relevant to
- Registry conditions: Essential Tremor, Upper Extremity Essential Tremor. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
Interventions
- Device Deep brain stimulation
Thalamic coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude, high frequency stimulation. Each participant will receive both the new intervention and the standard of care intervention, each for a week.
Primary outcome measures
- Tremor Research Group Essential Tremor Rating Scale (TETRAS) [Time frame: 4 months]
Secondary outcome measures (8)
- Instrumented Tremor Measurement [Time frame: 4 months]
- Bain Tremor Disability Scale (BTDS) [Time frame: 4 months]
- Quality of Life in Essential Tremor (QUEST) [Time frame: 4 months]
- Quantitative Archimedes Spirals [Time frame: 4 months]
- Dot Approximation Task [Time frame: 4 months]
- Brief Ataxia Rating Scale (BARS) [Time frame: 2 months]
- Quantitative Gait Analysis [Time frame: 2 months]
- Quantitative Speech Analysis [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of essential tremor (ET)
- Age of 21 or over
- Will be or has been implanted with Boston Scientific Vercise Rechargeable Genus deep brain stimulation (DBS) system
- 7 Tesla (7T) MRI pre-operative scan under Noam Harel PhD's Center for Magnetic Research (University of Minnesota IRB #1210M22183) protocol "Imaging of DBS targets at 7T MRI"
- Planned post-operative CT scan
Exclusion criteria
- History of musculoskeletal disorders that affect movement of the limbs or gait
- Other significant neurological disorder
- History of dementia or cognitive impairment that precludes them from getting DBS surgery
- Significant psychiatric disease
- On medication that could cause tremor
- Prior brain surgery
- Pregnant women
- Evidence of non-ET central nervous system disease or injury for at least three (3) months prior to implantation
- Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability
- Other significant medical disorder that could impede study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05897775 · NEUR-2023-31652