Coordinated Reset Deep Brain Stimulation for Essential Tremor

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 1

Conditions: Upper Extremity Essential Tremor; Essential Tremor

Treatments: Device: Deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05897775

NEUR-2023-31652

Details and patient eligibility

About

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).

Enrollment: 23 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Coordinated Reset DBS Setting (CR-DBS)

Experimental group

Description:

Coordinated Reset DBS settings

Treatment:

Device: Deep brain stimulation

Clinically Optimized DBS Setting (T-DBS)

Other group

Description:

Traditional DBS settings

Treatment:

Device: Deep brain stimulation