- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05303415
Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jessica W Florig, MPH
- Phone Number: 540-526-2261
- Email: legonlab@vtc.vt.edu
Study Locations
-
-
Virginia
-
Roanoke, Virginia, United States, 24016
- Recruiting
- Fralin Biomedical Research Institute
-
Contact:
- Jessica Florig, MPH
- Phone Number: 540-526-2375
- Email: legonlab@vtc.vt.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy volunteers, all ethnicities, who understand and speak English.
Exclusion Criteria:
Claustrophobia (scanning environment may be uncomfortable). Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
Contraindications to CT: pregnancy Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's) History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor) History of head injury resulting in loss of consciousness for >10 minutes. History of alcohol or drug dependence (through self-report).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIFU, heat evoked fMRI signals
fMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).
|
Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fMRI BOLD Signals
Time Frame: Participant study duration, approximately 3 weeks.
|
Changes in fMRI BOLD signal
|
Participant study duration, approximately 3 weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in self-reported perceived pain
Time Frame: Participant study duration, approximately 3 weeks.
|
Change in subject perceived pain rating report on a numerical rating scale (0-10, 0 no pain, 10 worst pain)
|
Participant study duration, approximately 3 weeks.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monitoring changes to physiological measures
Time Frame: Participant study duration, approximately 3 weeks.
|
Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.
|
Participant study duration, approximately 3 weeks.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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