tFUS to Enhance Alertness and Performance

NCT06461221 | Withdrawn Early Phase 1 DMC FDA Device

• 2 other identifiers: Pro00133395NBRFP23 P31
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Reaction Time; Alertness

Outcome Measures

Primary Outcomes (2)

• EEG changes pre- to post-FUS

  Frequency band analysis of EEG data

  2 years

• Reaction time on Psychomotor vigilance task

  Measuring reaction time on PVT pre- to post-FUS

  2 years

Study Arms (4)

Focused Ultrasound Dose #1

EXPERIMENTAL

Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes.

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.

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.

Device: Transcranial Focused Ultrasound

Focused Ultrasound Dose #4

SHAM COMPARATOR

Focused Ultrasound will be administered using the sham condition.

Device: Transcranial Focused Ultrasound

Interventions

Transcranial Focused Ultrasound DEVICE

Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions

Focused Ultrasound Dose #1

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Attune Neurosciences Inc: collaborator
• Nano-Bio Materials Consortium: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind sham-controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant receives 4 stimulation conditions in a counterbalanced order across 4 visits (1 stimulation condition/visit)

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: June 14, 2024
• Study Start: August 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

US (1)