Coordinated Reset Deep Brain Stimulation for Essential Tremor

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota

About this trial

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

Qualifiers

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"

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Deep brain stimulation

Treatment groups

23 Participants
are divided into 2 treatment groups

Sponsors and collaborators