Clinical trial NCT05897775: Coordinated Reset Deep Brain Stimulation for Essential Tremor
Official title: Coordinated Reset Deep Brain Stimulation for Essential Tremor
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Essential Tremor
Upper Extremity Essential Tremor
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 23
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: CROSSOVER
Intervention model description: Each participant will receive both the new intervention which is a new stimulation pattern and the standard of care intervention, each for a week.
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Essential Tremor (ET)
* Age of 21 or over
* Will be 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 (Mini-Mental Score \&lt; 26)
* 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

Primary outcomes:
measure: Tremor Research Group Essential Tremor Rating Scale (TETRAS)
timeFrame: 4 months
Secondary outcomes:
measure: Instrumented Tremor Measurement
timeFrame: 4 months
measure: Bain Tremor Disability Scale (BTDS)
timeFrame: 4 months
measure: Quality of Life in Essential Tremor (QUEST)
timeFrame: 4 months
measure: Quantitative Archimedes Spirals
timeFrame: 4 months
measure: Dot Approximation Task
timeFrame: 4 months
measure: Brief Ataxia Rating Scale (BARS)
timeFrame: 2 months
measure: Quantitative Gait Analysis
timeFrame: 2 months
measure: Quantitative Speech Analysis
timeFrame: 2 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jing Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: