RecruitingPhase 1NCT05897775

Coordinated Reset Deep Brain Stimulation for Essential Tremor

Sponsor

University of Minnesota

Enrollment

23 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Essential Tremor Upper Extremity Essential Tremor

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

Min Age: 21 Years

Inclusion Criteria5

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
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 Criteria10

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

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Interventions

DEVICEDeep 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.