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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04190940
Other study ID # 21483
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 18, 2019
Est. completion date April 17, 2021

Study information

Verified date December 2019
Source University of Virginia
Contact Sarah Adams
Phone 4342434319
Email neuromodlab@hscmail.mcc.virginia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 39
Est. completion date April 17, 2021
Est. primary completion date April 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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