Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals
1 other identifier
interventional
80
1 country
1
Brief Summary
Study of LIFU on fMRI pain signals. Participants receive low-intensity focused ultrasound (LIFU) and fMRI scans to measure changes in both resting and heat pain signals. Physiology may also be measured. Questionnaires and symptom monitoring will take place. The study takes place over 4 study visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started May 2022
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedStudy Start
First participant enrolled
May 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 8, 2026
June 1, 2026
5 years
March 11, 2022
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
fMRI BOLD Signals
Changes in fMRI BOLD signal
Participant study duration, approximately 3 weeks.
Secondary Outcomes (1)
Changes in self-reported perceived pain
Participant study duration, approximately 3 weeks.
Other Outcomes (1)
Monitoring changes to physiological measures
Participant study duration, approximately 3 weeks.
Study Arms (1)
LIFU, heat evoked fMRI signals
EXPERIMENTALfMRI resting and heat evoked signals performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).
Interventions
Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals
Eligibility Criteria
You may qualify if:
- Healthy volunteers, all ethnicities, who understand and speak English.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fralin Biomedical Research Institute
Roanoke, Virginia, 24016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 31, 2022
Study Start
May 6, 2022
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 8, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share