HealthyNCT05895474
Safety Assessment of Central Medial Thalamus Stimulation Using Transcranial Focused Ultrasound
A study testing Transcranial Focused Ultrasound in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Safety Assessment of Central Medial Thalamus Stimulation Using Attune ATTN201 Transcranial Focused Ultrasound Stimulator
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.
Read the 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
- Being tested
- Transcranial Focused Ultrasound
- Keywords
- Transcranial Focused Ultrasound (tFUS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Focused UltrasoundDevice
Using MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions
| Study group | Role | What they receive |
|---|---|---|
| Focused Ultrasound Dose #1 | Experimental | Focused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes. Receives: 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. Receives: 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. Receives: Device: Transcranial Focused Ultrasound |
| Focused Ultrasound Dose #4 | Sham comparator | Focused Ultrasound will be administered using the sham condition. Receives: Device: Transcranial Focused Ultrasound |
| Focused Ultrasound Dose #5 | Sham comparator | Focused Ultrasound will be administered using the sham condition. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Transcranial Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
Dose-response effects of tFUS on electroencephalographic (EEG) recordings
Comparing pre-tFUS and post-tFUS resting state EEG data will determine whether there are specific effects relating to the parameters administered.
Measured: 2 years
Effects of tFUS parameter alterations between part one and part two on electroencephalographic (EEG) recordings and behavior
Comparing within-subject part two results on behavioral tasks and EEG recordings to those found in part one
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 May 2023
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Responsible party
- Principal investigator, Allison Wilkerson, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895474
- Sponsor's protocol ID
- Pro00124407
- Status last verified
- Apr 2025
- First submitted
- 23 Mar 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Assessment of Central Medial Thalamus Stimulation Using Attune ATTN201 Transcranial Focused Ultrasound Stimulator
- ClinicalTrials.gov ID
- NCT05895474
- Acronym / sponsor ID
- Pro00124407
- Conditions
- Healthy
- Keywords
- Transcranial Focused Ultrasound (tFUS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Attune Neurosciences Inc
- Study start
- 15 May 2023 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Focused Ultrasound Dose #1 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using high frequency stimulation as condition 1. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #2 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using medium frequency stimulation as condition 2. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #3 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #4 | Sham comparator | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using the sham condition. |
| Focused Ultrasound Dose #5 | Sham comparator | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using the sham condition. |
| Focused Ultrasound Dose #6 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using low frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #7 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using medium frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
| Focused Ultrasound Dose #8 | Experimental | Device: Transcranial Focused UltrasoundFocused Ultrasound will be administered using high frequency stimulation as condition 4. Stimulation will last 1-10 minutes. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Focused UltrasoundUsing MRI-guided targeting, we will administer focused ultrasound in one of the 4 stimulation conditions | Device | 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 |
Primary outcome
Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire
Time frame: 2 years
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
Time frame: 2 years
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 secondary outcomes
Dose-response effects of tFUS on electroencephalographic (EEG) recordings
Time frame: 2 years
Effects of tFUS parameter alterations between part one and part two on electroencephalographic (EEG) recordings and behavior
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Focused Ultrasound in people with Healthy, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of tFUS in healthy adults looking at retention and with a tFUS credibility questionnaire (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.