Fralin Biomedical Research Institute
Roanoke, Virginia, 24016, United States
Location status: Recruiting
NCT Number: NCT05303415
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Roanoke, Virginia, 24016, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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).
Application of LIFU to induce temporary neuromodulation, effects tested with resting state and heat evoked (QST) fMRI signals
Time frame: Participant study duration, approximately 3 weeks.
Changes in fMRI BOLD signal
Time frame: 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)
Time frame: Participant study duration, approximately 3 weeks.
Monitoring for any changes to heartrate, blood pressure, respiratory rate, or galvanic skin response.
Contact information is provided by the study sponsor or research team.
Virginia Polytechnic Institute and State University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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