Algorithms for Programming DBS Systems for ET

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota

About this trial

Deep brain stimulation (DBS) targeting the Vim thalamus (ventralis intermedius nucleus) is an FDA-approved neuromodulation therapy for treating postural and action tremor in individuals with essential tremor (ET). The success of this treatment, however, is highly dependent on the ability of clinicians to identify therapeutic stimulation settings through a laborious programming process. There is a strong and growing clinical need for new approaches to provide clinicians with more efficient guidance on how to titrate stimulation settings. This study will leverage subject-specific computational models that can predict neural activation of axonal pathways adjacent to the active electrode(s) and implicated in the therapeutic mechanisms of Vim-DBS to in turn guide clinicians with which stimulation settings are likely to be the most therapeutic on tremor.

Eligibility criteria

Qualifiers

diagnosis of ET

medication-refractory tremor

VIM-DBS implant (unilateral or bilateral)

7T MRI pre-operative scan under Dr. Harel's IRB (institutional review board) protocol (#1210M22183)

Disqualifiers

history of musculoskeletal disorders that affect movement of the limbs

other significant neurological disorder

prior history of stereotactic neurosurgery (other than VIM-DBS surgery)

pregnancy

Trial design

Treatments tested in this trial

  • Vim-Deep Brain Stimulation

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators