Reaction TimeEarly Phase 1NCT06461221
tFUS to Enhance Alertness and Performance
A Early Phase 1 study testing Transcranial Focused Ultrasound in people with Reaction Time and Alertness, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Reaction Time, Alertness
- What is being tested?
- Transcranial Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to 1 Aug 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Reaction Time, Alertness
- Being tested
- Transcranial Focused Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focused UltrasoundDevice
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Transcranial Focused UltrasoundDevice
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Transcranial Focused UltrasoundDevice
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Transcranial Focused UltrasoundDevice
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound Dose #1 | Experimental | Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes. Receives: Device: Transcranial Focused Ultrasound |
| Focused Ultrasound Dose #2 | Experimental | Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes. Receives: Device: Transcranial Focused Ultrasound |
| Focused Ultrasound Dose #3 | Experimental | Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes. Receives: Device: Transcranial Focused Ultrasound |
| Focused Ultrasound Dose #4 | Sham comparator | Focused Ultrasound will be administered using the sham condition. Receives: Device: Transcranial Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG changes pre- to post-FUS
Frequency band analysis of EEG data
Measured: 2 years
Reaction time on Psychomotor vigilance task
Measuring reaction time on PVT pre- to post-FUS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Aug 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Why it stopped: Funding terminated prior to initiation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reaction TimeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each participant receives 4 stimulation conditions in a counterbalanced order across 4 visits (1 stimulation condition/visit)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Neurosciences Inc, Nano-Bio Materials Consortium
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461221
- Sponsor's protocol ID
- Pro00133395
- Other IDs
- NBRFP23 P31
- Status last verified
- Sep 2025
- First submitted
- 19 Apr 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Focused Ultrasound Stimulation of the Brain to Enhance Alertness and Cognitive Performance
- ClinicalTrials.gov ID
- NCT06461221
- Acronym / sponsor ID
- Pro00133395
- Conditions
- Reaction Time, Alertness
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding terminated prior to initiation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Attune Neurosciences Inc, Nano-Bio Materials Consortium
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Each participant receives 4 stimulation conditions in a counterbalanced order across 4 visits (1 stimulation condition/visit)
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound Dose #1 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #2 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #3 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #4 | Sham comparator | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using the sham condition. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Focused UltrasoundUsing MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions | Device | Focused Ultrasound Dose #1 |
| Transcranial Focused UltrasoundUsing MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions | Device | Focused Ultrasound Dose #2 |
| Transcranial Focused UltrasoundUsing MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions | Device | Focused Ultrasound Dose #3 |
| Transcranial Focused UltrasoundUsing MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions | Device | Focused Ultrasound Dose #4 |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transcranial Focused Ultrasound in people with Reaction Time and Alertness, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG changes pre- to post-FUS (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.