Individualized Focused Ultrasound Stimulation of the Brain to Enhance Alertness and Cognitive Performance
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Reaction Time
- Sponsor
- Medical University of South Carolina
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- EEG changes pre- to post-FUS
- Status
- Withdrawn
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
In this research study, the investigators will utilize a novel wearable device (ATTN201) to test the dose-response effects of FUS stimulation of the centromedian nucleus of the thalamus (CMT) on alertness, cognitive performance, and reaction time, as well as sleep EEG recordings. Unlike existing technologies, the device in this study will use offline MRI guidance, which is not needed during the actual treatment, allowing users for the first time to sleep and comfortably wear the device out of the clinic. This unique offline MRI guidance approach uses the device's precise head registration and brain anatomy to allow for customized and repeatable tFUS delivery to the CMT. For this study, the investigators will recruit up to 36 healthy subjects for a safety study that will objectively assess brain parenchyma morphology, and neuropsychiatric and neuropsychological function, following tFUS exposure of the CMT. EEG recordings during parametric sweeps will be obtained for observation of changes in brain network activity.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
EEG changes pre- to post-FUS
Time Frame: 2 years
Frequency band analysis of EEG data
Reaction time on Psychomotor vigilance task
Time Frame: 2 years
Measuring reaction time on PVT pre- to post-FUS