Recruiting

DBS Systems

Sponsor:

University of Minnesota

Code:

NCT03984643

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Vim-Deep Brain Stimulation

Study Details

Brief summary:

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.

Conditions

Essential Tremor

Study ID

NCT03984643

Start date

Oct 1, 2019

Status verified date

Jan, 2026

Completion date

Dec 31, 2031

Anticipated

Primary completion date

Dec 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)
  • Post-operative CT scan

Exclusion Criteria:

  • 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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Deep Brain Stimulation

Subjects in this study will have been implanted with a DBS lead in the VIM as part of their routine clinical care and have an existing set of brain MRI's.

Interventions

Vim-Deep Brain Stimulation

This study consists of testing additional model-derived DBS settings during initial and regular follow-up clinical visits every 6 months for up to 2 years in which individuals with DBS implants are re-evaluated by a clinician to make sure that the stimulation settings employed during the previous clinical visit remain therapeutic. It is important to note that this study is post-surgical and all procedures (i.e. stimulation settings that will be tested in the clinic) are within the FDA-approved range of stimulation settings available on the implanted pulse generator.

Primary outcome measure

  • Therapeutic Windows [ Time Frame: 24-months ]
  • Objective Measures of Tremor [ Time Frame: 24-months ]
  • Quality of Life Questionnaire: QUEST [ Time Frame: 24-months ]
  • Quality of Life Questionnaire: TETRAS [ Time Frame: 24-months ]

Central Contacts and Locations

Central contacts

Matthew Johnson, PhD

6126266492john5101@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Matthew Johnson, PhD

612-626-6492john5101@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jan 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-27.