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

Sponsor

Virginia Polytechnic Institute and State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05303415

Collaborator

(none)

Enrollment

Location

Arm

23.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Neuromodulation with low-intensity focused ultrasound	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

May 6, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

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).	Other: Neuromodulation with low-intensity focused ultrasound Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals

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).

Other: Neuromodulation with low-intensity focused ultrasound

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

Outcome Measures

Primary Outcome Measures

fMRI BOLD Signals [Participant study duration, approximately 3 weeks.]
Changes in fMRI BOLD signal

Secondary Outcome Measures

Changes in self-reported perceived pain [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)

Other Outcome Measures

Monitoring changes to physiological measures [Participant study duration, approximately 3 weeks.]
Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fralin Biomedical Research Institute	Roanoke	Virginia	United States	24016

Sponsors and Collaborators

Virginia Polytechnic Institute and State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wynn Legon, Assistant Professor, Virginia Polytechnic Institute and State University

ClinicalTrials.gov Identifier:

NCT05303415

Other Study ID Numbers:

22-247

First Posted:

Mar 31, 2022

Last Update Posted:

Aug 1, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 1, 2022