Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound

Sponsor

Medical University of South Carolina (Other)

Overall Status

Recruiting

CT.gov ID

NCT05895474

Collaborator

Attune Neurosciences (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: Transcranial Focused Ultrasound	N/A

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 week and will offer insights into preparing a larger clinical trial for tFUS use.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Each participant will receive 1 focused ultrasound stimulation conditions per visit for 4 visitsEach participant will receive 1 focused ultrasound stimulation conditions per visit for 4 visits

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Randomization files will be provided by the sponsor and be blinded to the participants, care provider, and investigators

Primary Purpose:

Basic Science

Official Title:

Safety Assessment of Central Medial Thalamus Stimulation Using Attune ATTN201 Transcranial Focused Ultrasound Stimulator

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Focused Ultrasound Dose #1 Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes.	Device: Transcranial Focused Ultrasound Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Experimental: Focused Ultrasound Dose #2 Focused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes.	Device: Transcranial Focused Ultrasound Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Experimental: Focused Ultrasound Dose #3 Focused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes.	Device: Transcranial Focused Ultrasound Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
Sham Comparator: Focused Ultrasound Dose #4 Focused Ultrasound will be administered using the sham condition.	Device: Transcranial Focused Ultrasound Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions

Outcome Measures

Primary Outcome Measures

Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire [Through study completion]
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.
Incidence of Adverse Events and Side Effects as assessed by Review of Systems Screener [Through study completion]
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.

Secondary Outcome Measures

Dose-response effects of tFUS on electroencephalographic (EEG) recordings [Baseline (MRI #1) and post stimulation (MRI #2)]
Comparing pre-tFUS and post-tFUS resting state EEG data will determine whether there are specific effects relating to the parameters administered.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina
Attune Neurosciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allison Wilkerson, Principal Investigator, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05895474

Other Study ID Numbers:

Pro00124407

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Allison Wilkerson, Principal Investigator, Medical University of South Carolina

Transcranial Focused Ultrasound (tFUS)

Study Results

No Results Posted as of Jun 8, 2023