tFUS to Enhance Alertness and Performance
September 2, 2025 updated by: Medical University of South Carolina
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Focused Ultrasound Dose #1
Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes.
|
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
|
|
Experimental: Focused Ultrasound Dose #2
Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes.
|
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
|
|
Experimental: Focused Ultrasound Dose #3
Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.
|
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
|
|
Sham Comparator: Focused Ultrasound Dose #4
Focused Ultrasound will be administered using the sham condition.
|
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EEG changes pre- to post-FUS
Time Frame: 2 years
|
Frequency band analysis of EEG data
|
2 years
|
|
Reaction time on Psychomotor vigilance task
Time Frame: 2 years
|
Measuring reaction time on PVT pre- to post-FUS
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2025
Primary Completion (Actual)
August 1, 2025
Study Completion (Actual)
August 1, 2025
Study Registration Dates
First Submitted
April 19, 2024
First Submitted That Met QC Criteria
June 11, 2024
First Posted (Actual)
June 14, 2024
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Pro00133395
- NBRFP23 P31 (Other Grant/Funding Number: Nano-Bio Materials Consortium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
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