NCT06461221

tFUS to Enhance Alertness and Performance

Individualized Focused Ultrasound Stimulation of the Brain to Enhance Alertness and Cognitive Performance

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 22 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Reaction Time
• Alertness

Interventions

Type	Name	Description
DEVICE	Transcranial Focused Ultrasound	Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
DEVICE	Transcranial Focused Ultrasound	Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
DEVICE	Transcranial Focused Ultrasound	Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
DEVICE	Transcranial Focused Ultrasound	Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions

Timeline

• Start date: 2025-08-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-06-14
• Last updated: 2025-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study