Autonomic Dysfunction Clinical Trial
Official title:
Investigation of Low-intensity Focused Ultrasound to the Salience Network on Autonomic Function
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal anterior insula (dAI) and dorsal anterior cingulate cortex (dACC) on autonomic control using three tests to probe the autonomic system. A cold pressor task, valsalva maneuver, and deep breathing tasks will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Does not meet exclusion criteria. Exclusion Criteria: The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance. - 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 central nervous system (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). - History of cardiac disease |
Country | Name | City | State |
---|---|---|---|
United States | Fralin Biomedical Research Institute at VTC | Roanoke | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Polytechnic Institute and State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sympathetic tone response - Heart Rate Variability (HRV) | Changes in HRV | through study completion, an average of 1 month | |
Primary | Sympathetic tone response - Heart Rate (HR) | Changes in HR | through study completion, an average of 1 month | |
Primary | Sympathetic tone response - Blood Pressure (BP) | Changes in BP (systolic and diastolic pressure) | through study completion, an average of 1 month | |
Primary | Sympathetic tone response - Electrodermal Response (EDR) | Changes in EDR | through study completion, an average of 1 month | |
Primary | Sympathetic tone response - Electroencephalography (EEG) | Changes in low and high frequency power | through study completion, an average of 1 month |
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