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Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

Study of Low-intensity Focused Ultrasound Effects on Heat Evoked fMRI Signals

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05303415
Enrollment
80
Registered
2022-03-31
Start date
2022-05-06
Completion date
2027-12-01
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Detailed description

Study aims to examine the effects of noninvasive brain stimulation on brain signals. This insight may have potential clinical implications for addiction, pain, and mental health populations. Participants will receive MRI and CT imaging. Participants receive low-intensity focused ultrasound (LIFU) to temporarily change brain activity. Participants then receive fMRI scans to measure changes in both resting and heat evoked brain signaling using a quantitative sensory testing device. Heart rate, blood pressure, respiratory rate, and skin moisture is monitored. Participants complete a battery of questionnaires, both behavioral and symptom monitoring. The study takes place over 4 study visits.

Interventions

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

Sponsors

Virginia Polytechnic Institute and State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
fMRI BOLD SignalsParticipant study duration, approximately 3 weeks.Changes in fMRI BOLD signal

Secondary

MeasureTime frameDescription
Changes in self-reported perceived painParticipant 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)

Countries

United States

Contacts

CONTACTJessica W Florig, MPH
legonlab@vtc.vt.edu540-526-2261

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 9, 2026