High Intensity Focused UltrasoundNCT04190940
Interactions of Brain Regions in Visuomotor Adaptation
A study testing Behavioral Assessment in people with High Intensity Focused Ultrasound and Deep Brain Stimulation, run by University of Virginia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- High Intensity Focused Ultrasound, Deep Brain Stimulation
- What is being tested?
- Behavioral Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2019to 17 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Sarah Adams, 434-243-4319, neuromodlab@hscmail.mcc.virginia.edu
Wynn Legon, PhD
About this study
Official title: 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.
- Being tested
- Behavioral Assessment
- Keywords
- Ultrasound, Thalamus, Cerebellum, Basal Ganglia, Deep Brain Stimulation, High Intensity Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral AssessmentBehavioural
Patients will be asked to complete the behavioral assessment before and after their HIFU treatment or "on" and "off" their DBS treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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". Receives: Behavioral: Behavioral Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, a week after HIFU treatment, several weeks after DBS implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start18 Apr 2019
- Primary completion17 Apr 2021 (estimated)
- Study completion17 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Intensity Focused UltrasoundStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190940
- Sponsor's protocol ID
- 21483
- Status last verified
- Dec 2019
- First submitted
- 17 Nov 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Interaction of Thalamus, Basal Ganglia, and the Cerebellum in Visuomotor Adaptation
- ClinicalTrials.gov ID
- NCT04190940
- Acronym / sponsor ID
- 21483
- Keywords
- Ultrasound, Thalamus, Cerebellum, Basal Ganglia, Deep Brain Stimulation, High Intensity Focused Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 17 Apr 2021 (estimated)
- Study completion
- 17 Apr 2021 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Focused Ultrasound | Experimental | Behavioral: Behavioral AssessmentPatients receiving high intensity focused ultrasound as a treatment will be asked to complete the behavioral task pre and post their treatment. |
| Deep Brain Stimulation | Experimental | Behavioral: Behavioral AssessmentPatients receiving deep brain stimulation as a treatment will be asked to complete the behavioral task while their DBS electrode is "on" and "off". |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral AssessmentPatients will be asked to complete the behavioral assessment before and after their HIFU treatment or "on" and "off" their DBS treatment. | Behavioural | Deep Brain Stimulation, High Intensity Focused Ultrasound |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Assessment in people with High Intensity Focused Ultrasound and Deep Brain Stimulation, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Adams (4342434319, neuromodlab@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Error on Visuomotor Task (time frame: baseline, a week after HIFU treatment, several weeks after DBS implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.