Interactions of Brain Regions in Visuomotor Adaptation

December 5, 2019 updated by: University of Virginia

Functional Interaction of Thalamus, Basal Ganglia, and the Cerebellum in Visuomotor Adaptation

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • University of Virginia
        • Principal Investigator:
          • Wynn Legon, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Behavioral Assessment
Patients will be asked to complete the behavioral assessment before and after their HIFU treatment or "on" and "off" their DBS 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".
Behavioral: Behavioral Assessment
Patients will be asked to complete the behavioral assessment before and after their HIFU treatment or "on" and "off" their DBS treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Error on Visuomotor Task
Time Frame: baseline, a week after HIFU treatment, several weeks after DBS implantation
The visuomotor task has practice, baseline, and experimental trials. Performance on the task will be compared between groups (HIFU treatment and DBS treatment) before and after treatment.
baseline, a week after HIFU treatment, several weeks after DBS implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2019

Primary Completion (Anticipated)

April 17, 2021

Study Completion (Anticipated)

April 17, 2021

Study Registration Dates

First Submitted

November 17, 2019

First Submitted That Met QC Criteria

December 5, 2019

First Posted (Actual)

December 9, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21483

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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