NCT04190940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

2 years

First QC Date

November 17, 2019

Last Update Submit

December 5, 2019

Conditions

Keywords

UltrasoundThalamusCerebellumBasal GangliaDeep Brain StimulationHigh Intensity Focused Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Performance Error on Visuomotor Task

    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

Study Arms (2)

High Intensity Focused Ultrasound

EXPERIMENTAL

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

Deep Brain Stimulation

EXPERIMENTAL

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

Interventions

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

Deep Brain StimulationHigh Intensity Focused Ultrasound

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide consent or complete study procedures
  • Women who self-report pregnancy
  • Patients who are currently incarcerated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2019

First Posted

December 9, 2019

Study Start

April 18, 2019

Primary Completion

April 17, 2021

Study Completion

April 17, 2021

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations