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

Not Applicable

Not yet recruiting

• Conditions: Cognitive Change
• Interventions: Other: Neuromodulation with low-intensity focused ultrasound

• Registration Number: NCT05303428
• Lead Sponsor: Virginia Polytechnic Institute and State University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-04
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Start: 2025-10
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy volunteers, all ethnicities, who understand and speak English.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LIFU, fMRI Cognitive	Neuromodulation with low-intensity focused ultrasound	fMRI resting and cognitive tasks performed after LIFU application to known brain region of interest or active sham region (within participant all conditions tested).

Primary Outcome Measures

Name	Time	Method
fMRI Signals - Cognition	Participant study duration, approximately 3 weeks.	Changes in fMRI signals of region of interest during a cognitive task

Secondary Outcome Measures

Name	Time	Method
Executive function task performance	Participant study duration, approximately 3 weeks.	Testing effects of LIFU on altered task performance