Recruiting

Observational Study

Sponsor:

University of Virginia

Code:

NCT04190940

Conditions

High Intensity Focused Ultrasound

Deep Brain Stimulation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Behavioral Assessment

Study Details

Brief summary:

The purpose of this study is to better understand the roles the cerebellum, basal ganglia, and thalamus play in motor learning. Patients undergoing High Intensity Focused Ultrasound (HIFU) treatment will be receiving an ablation procedure to their thalamus as a part of their medical procedure. Participation in this study will include completing a behavioral task before and after the procedure to see how motor learning task performance differs with and without the thalamus. Similarly, patients undergoing Deep Brain Stimulation (DBS) treatment will have an electrode implanted in their thalamus as a part of their medical procedures. Participation in this study will include completing the motor learning task performance "on" and "off" thalamic electrical stimulation.

Conditions

High Intensity Focused Ultrasound

Deep Brain Stimulation

Study ID

NCT04190940

Start date

Apr 18, 2019

Status verified date

Dec, 2019

Completion date

Apr 17, 2021

Anticipated

Primary completion date

Apr 17, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be a patient receiving either high intensity focused ultrasound treatment or deep brain stimulation treatment for Tremor
  • Able to provide informed consent and complete study procedures
  • Must speak English
  • Age 18-85

Exclusion Criteria:

  • Not receiving one of the specified inclusion criteria
  • Unable to provide consent or complete study procedures
  • Women who self-report pregnancy
  • Patients who are currently incarcerated

Study Design

Enrollment

39 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: High Intensity Focused Ultrasound

Patients receiving high intensity focused ultrasound as a treatment will be asked to complete the behavioral task pre and post their treatment.

experimental: Deep Brain Stimulation

Patients receiving deep brain stimulation as a treatment will be asked to complete the behavioral task while their DBS electrode is "on" and "off".

Interventions

Behavioral Assessment

Patients will be asked to complete the behavioral assessment before and after their HIFU treatment or "on" and "off" their DBS treatment.

Primary outcome measure

  • Performance Error on Visuomotor Task [ Time Frame: baseline, a week after HIFU treatment, several weeks after DBS implantation ]

Central Contacts and Locations

Central contacts

Sarah Adams

4342434319neuromodlab@hscmail.mcc.virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Sarah Adams

434-243-4319neuromodlab@hscmail.mcc.virginia.edu

Principal Investigator:

Wynn Legon, PhD

More Information

Sponsor

University of Virginia

Last update posted

Dec 9, 2019

Last verified

Dec, 2019

Keywords

  • Ultrasound
  • Thalamus
  • Cerebellum
  • Basal Ganglia
  • Deep Brain Stimulation
  • High Intensity Focused Ultrasound

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 Virginia on 2019-12-09.