Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

NCT05895474 | Completed DMC FDA Device

• 1 other identifier: Pro00124407
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Transcranial Focused Ultrasound (tFUS)

Outcome Measures

Primary Outcomes (2)

• Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire

  A credibility questionnaire will be used to asses feasibility. The credibility scale maximum is 36 and minimum is 0, a higher ratings means higher credibility score which is a better outcome.

  2 years

• Incidence of Adverse Events and Side Effects as assessed by Review of Systems Screener

  This study will be demonstrating the safety of using tFUS in healthy adults by assessing adverse events and side effects using the Review of Systems (RSS) questionnaire. The minimum value of the RSS scale is 0 and the maximum is 75, the higher the score the more severe the side effects meaning a worse outcome.

  2 years

Secondary Outcomes (2)

• Dose-response effects of tFUS on electroencephalographic (EEG) recordings

  2 years

• Effects of tFUS parameter alterations between part one and part two on electroencephalographic (EEG) recordings and behavior

  2 years

Study Arms (8)

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

Focused Ultrasound Dose #5

SHAM COMPARATOR

Focused Ultrasound will be administered using the sham condition.

Device: Transcranial Focused Ultrasound

Focused Ultrasound Dose #6

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 #7

EXPERIMENTAL

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

Device: Transcranial Focused Ultrasound

Focused Ultrasound Dose #8

EXPERIMENTAL

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

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; Focused Ultrasound Dose #2; Focused Ultrasound Dose #3; Focused Ultrasound Dose #4; Focused Ultrasound Dose #5; Focused Ultrasound Dose #6; Focused Ultrasound Dose #7; Focused Ultrasound Dose #8

Eligibility Criteria

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

You may qualify if:

• 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

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

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomization files will be provided by the sponsor and be blinded to the participants, care provider, and investigators
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Part One: Each participant will receive 1 focused ultrasound stimulation conditions per visit for 4 visits Part Two: If called back, participant will receive 1 focused ultrasound stimulation conditions per visit for 4 visits

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: June 8, 2023
• Study Start: May 15, 2023
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)