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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303415
• Other study ID #: 22-247
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2022
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Virginia Polytechnic Institute and State University
• Contact: Jessica W Florig, MPH
• Phone: 540-526-2261
• Email: legonlab[@]vtc.vt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Monitoring changes to physiological measures	Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.	Participant study duration, approximately 3 weeks.
Primary	fMRI BOLD Signals	Changes in fMRI BOLD signal	Participant study duration, approximately 3 weeks.
Secondary	Changes in self-reported perceived pain	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.