Recruiting

Low-intensity Focused Ultrasound

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT05303415

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Neuromodulation with low-intensity focused ultrasound

Study Details

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.

Conditions

Pain

Study ID

NCT05303415

Start date

May 6, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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).

Interventions

Neuromodulation with low-intensity focused ultrasound

Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

Primary outcome measure

  • fMRI BOLD Signals [ Time Frame: Participant study duration, approximately 3 weeks. ]

Central Contacts and Locations

Central contacts

Jessica W Florig, MPH

540-526-2261legonlab@vtc.vt.edu

Locations

Fralin Biomedical Research Institute

Recruiting

Roanoke, Virginia, United States, 24016

Contacts

Jessica Florig, MPH

5405262375legonlab@vtc.vt.edu

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2026-06-08.