Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

NCT ID: NCT05895474

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2025-04-23

Brief Summary

The purposes of this research study are to investigate closed-loop and personalized focused ultrasound as a technique to study how the brain works and to evaluate the safety and effectiveness of the Attune ATTN201 device. This study will objectively assess brain parenchyma morphology, and neuropsychiatric and neuropsychological function, following Transcranial Focused Ultrasound (tFUS) exposure. Electroencephalographic recordings during parametric sweeps will be obtained for observation of changes in the brain network activity, primarily focused on the Central Medial Thalamus (CMT). The CMT maintains strong network connectivity to the cortex and plays a potent role in sleep induction. tFUS has recently emerged as a powerful tool for targeted deep brain neuromodulation and has, in theory, the ability to modulate the activity of the CMT without affecting overlying tissue.

Detailed Description

This research study will examine the safety and tolerability of the novel, wearable device Attune ATTN201. This device uses transcranial focused ultrasound (tFUS), a form of noninvasive brain stimulation that uses sound waves to excite or inhibit the brain. The investigators research questions seek to answer how using brain imaging can guide the use of tFUS to stimulate a specific target unique to the participant's brain. This target, the Thalamus, is involved in everyday brain processing and activity. Using the participant's specific brain anatomy and tFUS, the investigators can precisely target this structure and further understand its role in the various functions. Unlike existing technologies, this device will incorporate offline usage, allowing users to comfortably wear the device out of the clinic or research setting for the first time. The unique offline guidance approach uses the participant's head shape and brain anatomy to allow for customizable and repeatable ultrasound delivery to exact, preprogrammed targets. This device will be tested over the course of 1 month per participant, and will offer insights into preparing a larger clinical trial for tFUS use.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Focused Ultrasound Dose #1

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

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #2

Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes.

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #3

Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #4

Focused Ultrasound will be administered using the sham condition.

Group Type: SHAM_COMPARATOR

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #5

Focused Ultrasound will be administered using the sham condition.

Group Type: SHAM_COMPARATOR

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #6

Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #7

Focused Ultrasound will be administered using medium frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Focused Ultrasound Dose #8

Focused Ultrasound will be administered using high frequency stimulation as condition 4. Stimulation will last 1-10 minutes.

Group Type: EXPERIMENTAL

Transcranial Focused Ultrasound

Intervention Type: DEVICE

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

Interventions

Transcranial Focused Ultrasound

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female
• Age 22-55
• Endorse good health with no history of mental or physical illness or implanted metal
• English as a primary language
• Capacity to consent
• Negative urine pregnancy test if a female of childbearing potential
• Willingness to adhere to the tFUS study schedule and assessments

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Attune Neurosciences Inc

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Allison Wilkerson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro00124407

Identifier Type: -

Identifier Source: org_study_id