Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals

Cognitive Change Clinical Trial

Official title:

Study of Low-intensity Focused Ultrasound Effects on Cognitive fMRI Signals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05303428
• Other study ID #: 22-243
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Virginia Polytechnic Institute and State University
• Contact: Jessica Florig, MPH
• Phone: 5405262375
• 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 cognitive brain signaling using structured tasks. 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: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• 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:

1. Claustrophobia (scanning environment may be uncomfortable).

2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.

3. Contraindications to CT: pregnancy

4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer's)

5. History of neurologic disorder. (e.g. Parkinson's, Epilepsy, or Essential Tremor)

6. History of head injury resulting in loss of consciousness for >10 minutes.

7. History of alcohol or drug dependence (through self-report).

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Other:
• Neuromodulation with low-intensity focused ultrasound
application of LIFU to induce temporary neuromodulation, effects tested with resting state and task based fMRI scanning.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess for changes in physiological measures	Monitoring for any changes in heartrate, blood pressure, respiratory rate, or galvanic skin response throughout testing	Participant study duration, approximately 3 weeks.
Primary	fMRI Signals - Cognition	Changes in fMRI signals of region of interest during a cognitive task	Participant study duration, approximately 3 weeks.
Secondary	Executive function task performance	Testing effects of LIFU on altered task performance	Participant study duration, approximately 3 weeks.