Reaction Time Clinical Trial
Official title:
Individualized Focused Ultrasound Stimulation of the Brain to Enhance Alertness and Cognitive Performance
The investigators goal is to target FUS energy to the centromedian nucleus of the thalamus (CMT), the core of arousal, which is inaccessible by traditional non-invasive neuromodulation devices. The CMT is an ideal stimulation target for augmenting alertness, as it is intimately linked with the cortex through the well described thalamocortical circuit to entrain network oscillations.
Status | Not yet recruiting |
Enrollment | 36 |
Est. completion date | August 1, 2026 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 55 Years |
Eligibility | Inclusion Criteria: - 22 - 55 y.o. - Endorse good health with no history of mental or physical illness - Negative urine pregnancy test if female - Willingness to adhere to the FUS study schedule and assessments - Able to read consent document and provide informed consent. - English is a first or primary fluent language. Exclusion Criteria: - Any current psychiatric diagnosis or current Clinical Global Impression ratings of psychiatric illness > 1 - Neurodevelopmental disorders, history of CNS disease, concussion, overnight hospitalization, or other neurologic sequela, tumors, seizures, meningitis, encephalitis, or abnormal CT or MRI of the brain - Any psychotropic medication is taken within 5 half-lives of procedure time - Any head trauma resulting in loss of consciousness - Visual impairment (except the use of glasses) - Inability to complete cognitive testing - Active participation or plan for enrollment in another evidence-based clinical trial affecting the psychosocial function - Repeated abuse or dependence upon drugs (excluding nicotine and caffeine) or taking medications including stimulants, modafinil, thyroid medication, or steroids - Implanted devices/ferrous metal of any kind - History of seizure or epilepsy, currently taking medications that lower seizure thresholds - Claustrophobia or other conditions that would prevent the MRI assessment. - Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). - Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precautions should be taken. Examples of acceptable methods of birth control for participants involved in the study include birth control pills, patches, IUDs, condoms, sponges, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. - Inability to adhere to the treatment schedule. - Inability to fit the wearable device to the user's head. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EEG changes pre- to post-FUS | Frequency band analysis of EEG data | 2 years | |
Primary | Reaction time on Psychomotor vigilance task | Measuring reaction time on PVT pre- to post-FUS | 2 years |
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