Depressive Disorder, MajorPhase 1/2DMNtFUSNCT06320028
Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms
A Phase 1/2 study testing Non-Invasive Transcranial Focused Ultrasound in people with Depressive Disorder, Major and Depression, run by University of Arizona at 1 site in United States.
Trial summary
Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Depressive Disorder, Major, Depression
- What is being tested?
- Non-Invasive Transcranial Focused Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 3 Jun 2024
- Phase
- Phase 1/2
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants must be between the ages of 18-50
- Participants must have normal or corrected vision (glasses, contacts, etc)
- Must be proficient in English in order to read the consent form (Spanish speakers are included, as long as they are also proficient in English)
- Must be right-handed
- Upper 25% of distribution on perseverative thinking scores based on local norms (score ≥ 37)
- Participants meeting DSM-5 criteria for current major depressive episode
- Participants may be excluded from the MRI portion of the experiment if they are pregnant or are unsure if they may be pregnant or have any contraindications for MRI, including severe claustrophobia, non-MRI compatible cardiac pacemakers; implantable defibrillators; aneurysm clips; neural stimulators; artificial heart valves; ear implants; insulin pumps; drug infusion devices; IUDs; magnetic dental appliances; metal fragments or foreign objects in the eyes, skin or body; metal plates, screws, and prosthetics; non-removable metal piercings; tattoos on the head and neck, other certain older tattoos or permanent makeup (eyeliner) using metal-containing inks, some medicated patches, or any other condition, metal implant or other injury or device that is contraindicated for MRI. If a subject has any of these, the experimenter will evaluate whether it is safe for them to participate in the MRI portion of the experiment.
Who cannot join
- History of head injury with loss of consciousness for more than 5 min
- Uncorrected hearing or vision impairment severe enough to interfere with participation.
- Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence
- Sleep disorder (e.g., insomnia)
- Current drug, alcohol, or prescription drug intoxication
- History of epilepsy
Show all 10Show fewer
- History of diagnosed migraines
- Metal implants in their head or face, including dental retainers that cannot be removed
- History of cardiac problems that could impact brain function (e.g., atrial fibrillation)
- Current active suicidal potential necessitating immediate treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altering Default Mode Network Activity to Reduce Depressive Symptoms
Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT.
Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.
The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention.
Read the detailed description
Participants will first complete the online screening to identify those who may meet criteria of major depressive disorder and have high RNT. Those meeting these criteria will be contacted for a formal diagnostic interview, consisting of the consent process and a structured clinical interview using the DSM-5. Once deemed eligible, participants will complete baseline interviews, self-report surveys, and an MRI session. Then, they will complete up to three weeks of ultrasound treatment, wherein the first week consists of five ultrasound sessions. Upon completion of week one, participants will complete the same interview, self-report surveys, and MRI session. Participants' symptom improvement will be determined by whether they meet remission criteria, defined as a Beck Depression Inventory Score - II (BDI-II) of <13 and a Hamilton Depression Rating Scale (HDRS) score of <8. If remission criteria are not met, participants will continue ultrasound sessions for two more weeks, three sessions per week. Following completion, participants will complete a final interview, self-report surveys, and MRI session. In each treatment session, the ultrasound device will be placed on the participants' forehead with the aid of the customized headset co-localized to the participant's structural MR image. Each ultrasound treatment lasts ten minutes.
- Conditions
- Depressive Disorder, Major, Depression
- Being tested
- Non-Invasive Transcranial Focused Ultrasound
- Keywords
- Non-invasive Transcranial Focused Ultrasound Stimulation, Depression, Mood disorders
- Medical subject headings
- Depressive Disorder, Major, Depression, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Transcranial Focused UltrasoundDevice
The ultrasound will be delivered for 10 minutes per treatment session targeting to the participant's amPFC.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive Transcranial Focused Ultrasound | Experimental | Device: Transcranial Ultrasound Power
The ultrasound will be delivered using a custom Neuromodulation device consisting of 128 element ultrasound array (Openwater) with the ultrasound beam having the following parameters: acoustic frequency = 400 kHz, pulse duration = 5 ms, pulse repetition rate (PRR) = 10 Hz, spatial peak/temporal average acoustic intensity = 435 mW /cm2, peak negative pressure 650 kPa. The ultrasound probe will be secured by a custom-designed headset created by Openwater. The Localite Neuronavigation Software (TMS Navigator 3.3 adapted for ultrasound device), including a 3D camera, fiducial markers on the headset and pointer, and software will register the position of the probe with respect to the patient's structural MRI. Receives: Device: Non-Invasive Transcranial Focused Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory - II (BDI-II)
The BDI-II is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms over the course of treatment. In our research, we will employ the BDI-II to track changes in self-reported depressive symptoms throughout the intervention, comparing the total BDI-II scores at different assessment points to analyze the efficacy of the treatment.
Measured: Before ultrasound treatment, daily after each ultrasound session, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Perseverative Thinking Questionnaire (PTQ)
The PTQ is a commonly used self-report measure for assessing a characteristic of depression, repetitive negative thought (RNT). It includes 15 self-report items. Scores range from 0 to 60, and higher scores indicate higher levels of RNT. In this study, the PTQ was used to monitor RNT over the course of treatment. In our research, we will employ the PTQ to track changes in RNT throughout the intervention, comparing the total PTQ scores at different assessment points to analyze the efficacy of the treatment.
Measured: Before ultrasound treatment, daily after each ultrasound session, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Hamilton Depression Rating Scale (HDRS)
The Hamilton Depression Rating Scale (HDRS) is a widely utilized clinician-administered assessment tool designed to measure the severity of depressive symptoms in individuals. Comprising 17 items, the HDRS evaluates various aspects of depression. Scores range from 0 to 52, and higher total scores indicate greater depressive symptoms. In our research, we will employ the HDRS to track changes in depressive symptoms throughout the intervention, comparing the total HDRS scores at each main time point to analyze the efficacy of the treatment.
Measured: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Default Mode Network (DMN) Connectivity
The DMN is a set of brain regions known to be "hyperconnected" in depressed individuals and may be a potential biomarker for this costly disorder. In our research, we will compare DMN connectivity at each major time point to observe whether there is a decrease in DMN connectivity to assess the efficacy of treatment.
Measured: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Secondary outcomes (1)
The Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a clinician-administered assessment tool commonly used to evaluate the severity of depressive symptoms in individuals. It consists of 10 items that assess various aspects of depression. Scores range from 0 to 60, with higher scores indicating more severe depressive symptoms. In our research, we will employ the MADRS to track changes in depressive symptoms throughout the intervention, comparing the total MADRS scores at each main time point to analyze the efficacy of the treatment.
Measured: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start27 Apr 2023
- Primary completion3 Jan 2024
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same treatment protocol.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Openwater
- Responsible party
- Principal investigator, John Allen, University of Arizona
- Investigators
- John JB Allen, PhD, Principal investigator, University of Arizona Psychology DepartmentJessica N Schachtner, BA, Principal investigator, University of Arizona Psychology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320028
- Sponsor's protocol ID
- 019782-00001
- Acronym
- DMNtFUS
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fini M, Tyler WJ. Transcranial focused ultrasound: a new tool for non-invasive neuromodulation. Int Rev Psychiatry. 2017 Apr;29(2):168-177. doi: 10.1080/09540261.2017.1302924. Epub 2017 Apr 21.
PubMed 28430535Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
PubMed 29385924Samantha J. Reznik, Joseph L. Sanguinetti, William J. Tyler, Chris Daft, John J.B. Allen. (2020) A double-blind pilot study of transcranial ultrasound (TUS) as a five-day intervention: TUS mitigates worry among depressed participants, Neurology, Psychiatry and Brain Research, 37(60-66), ISSN 0941-9500, https://doi.org/10.1016/j.npbr.2020.06.004.
Sanguinetti JL, Hameroff S, Smith EE, Sato T, Daft CMW, Tyler WJ, Allen JJB. Transcranial Focused Ultrasound to the Right Prefrontal Cortex Improves Mood and Alters Functional Connectivity in Humans. Front Hum Neurosci. 2020 Feb 28;14:52. doi: 10.3389/fnhum.2020.00052. eCollection 2020.
PubMed 32184714Sanguinetti, J. L., Smith, E., Allen, J. J. B., Hameroff, S. (2014). Human brain stimulation with transcranial ultrasound (TUS); Potential applications for mental health. In Bioelectromagnetic Medicine. New York, NY: Taylor & Francis.
Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.
PubMed 19171889Schachtner JN, Dahill-Fuchel JF, Zhang D, Allen KE, Bawiec CR, Hollender PJ, Ornellas SB, Konecky SD, Achrol AS, Allen JJB. The effect of non-invasive transcranial focused ultrasound for depression on the default mode network: an open-label pilot trial. Front Psychiatry. 2026 Jan 20;16:1722575. doi: 10.3389/fpsyt.2025.1722575. eCollection 2025.
PubMed 41641082Schachtner JN, Dahill-Fuchel JF, Allen KE, Bawiec CR, Hollender PJ, Ornellas SB, Konecky SD, Achrol AS, Allen JJB. Transcranial focused ultrasound targeting the default mode network for the treatment of depression. Front Psychiatry. 2025 Apr 4;16:1451828. doi: 10.3389/fpsyt.2025.1451828. eCollection 2025.
PubMed 40256163
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering Default Mode Network Activity to Reduce Depressive Symptoms
- ClinicalTrials.gov ID
- NCT06320028
- Acronym / sponsor ID
- DMNtFUS / 019782-00001
- Conditions
- Depressive Disorder, Major, Depression
- Keywords
- Non-invasive Transcranial Focused Ultrasound Stimulation, Depression, Mood disorders
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Openwater
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 20 Mar 2024 (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.
Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT.
Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision.
The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention.
Detailed description
Participants will first complete the online screening to identify those who may meet criteria of major depressive disorder and have high RNT. Those meeting these criteria will be contacted for a formal diagnostic interview, consisting of the consent process and a structured clinical interview using the DSM-5. Once deemed eligible, participants will complete baseline interviews, self-report surveys, and an MRI session. Then, they will complete up to three weeks of ultrasound treatment, wherein the first week consists of five ultrasound sessions. Upon completion of week one, participants will complete the same interview, self-report surveys, and MRI session. Participants' symptom improvement will be determined by whether they meet remission criteria, defined as a Beck Depression Inventory Score - II (BDI-II) of <13 and a Hamilton Depression Rating Scale (HDRS) score of <8. If remission criteria are not met, participants will continue ultrasound sessions for two more weeks, three sessions per week. Following completion, participants will complete a final interview, self-report surveys, and MRI session. In each treatment session, the ultrasound device will be placed on the participants' forehead with the aid of the customized headset co-localized to the participant's structural MR image. Each ultrasound treatment lasts ten minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same treatment protocol.
| Arm | Type | Receives |
|---|---|---|
| Non-invasive Transcranial Focused Ultrasound | Experimental | Device: Non-Invasive Transcranial Focused UltrasoundDevice: Transcranial Ultrasound Power The ultrasound will be delivered using a custom Neuromodulation device consisting of 128 element ultrasound array (Openwater) with the ultrasound beam having the following parameters: acoustic frequency = 400 kHz, pulse duration = 5 ms, pulse repetition rate (PRR) = 10 Hz, spatial peak/temporal average acoustic intensity = 435 mW /cm2, peak negative pressure 650 kPa. The ultrasound probe will be secured by a custom-designed headset created by Openwater. The Localite Neuronavigation Software (TMS Navigator 3.3 adapted for ultrasound device), including a 3D camera, fiducial markers on the headset and pointer, and software will register the position of the probe with respect to the patient's structural MRI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must be between the ages of 18-50
- Participants must have normal or corrected vision (glasses, contacts, etc)
- Must be proficient in English in order to read the consent form (Spanish speakers are included, as long as they are also proficient in English)
- Must be right-handed
- Upper 25% of distribution on perseverative thinking scores based on local norms (score ≥ 37)
Key exclusion criteria (10 listed)
- History of head injury with loss of consciousness for more than 5 min
- Uncorrected hearing or vision impairment severe enough to interfere with participation.
- Currently have or history of brain or mental illness judged likely to interfere with testing, including drug and/or alcohol dependence
- Sleep disorder (e.g., insomnia)
- Current drug, alcohol, or prescription drug intoxication
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 |
|---|---|---|
| Non-Invasive Transcranial Focused UltrasoundThe ultrasound will be delivered for 10 minutes per treatment session targeting to the participant's amPFC. | Device | Non-invasive Transcranial Focused Ultrasound |
Primary outcome
Beck Depression Inventory - II (BDI-II)
Time frame: Before ultrasound treatment, daily after each ultrasound session, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
The BDI-II is one of the most widely used self-report measures for assessing depression. It includes 21 self-report items. Scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms. In this study, the BDI-II was used to monitor depressive symptoms over the course of treatment. In our research, we will employ the BDI-II to track changes in self-reported depressive symptoms throughout the intervention, comparing the total BDI-II scores at different assessment points to analyze the efficacy of the treatment.
Perseverative Thinking Questionnaire (PTQ)
Time frame: Before ultrasound treatment, daily after each ultrasound session, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
The PTQ is a commonly used self-report measure for assessing a characteristic of depression, repetitive negative thought (RNT). It includes 15 self-report items. Scores range from 0 to 60, and higher scores indicate higher levels of RNT. In this study, the PTQ was used to monitor RNT over the course of treatment. In our research, we will employ the PTQ to track changes in RNT throughout the intervention, comparing the total PTQ scores at different assessment points to analyze the efficacy of the treatment.
Hamilton Depression Rating Scale (HDRS)
Time frame: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
The Hamilton Depression Rating Scale (HDRS) is a widely utilized clinician-administered assessment tool designed to measure the severity of depressive symptoms in individuals. Comprising 17 items, the HDRS evaluates various aspects of depression. Scores range from 0 to 52, and higher total scores indicate greater depressive symptoms. In our research, we will employ the HDRS to track changes in depressive symptoms throughout the intervention, comparing the total HDRS scores at each main time point to analyze the efficacy of the treatment.
Default Mode Network (DMN) Connectivity
Time frame: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
The DMN is a set of brain regions known to be "hyperconnected" in depressed individuals and may be a potential biomarker for this costly disorder. In our research, we will compare DMN connectivity at each major time point to observe whether there is a decrease in DMN connectivity to assess the efficacy of treatment.
1 secondary outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: Before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Background: PubMed 28430535Fini M, Tyler WJ. Transcranial focused ultrasound: a new tool for non-invasive neuromodulation. Int Rev Psychiatry. 2017 Apr;29(2):168-177. doi: 10.1080/09540261.2017.1302924. Epub 2017 Apr 21.
- Background: PubMed 29385924Kubanek J. Neuromodulation with transcranial focused ultrasound. Neurosurg Focus. 2018 Feb;44(2):E14. doi: 10.3171/2017.11.FOCUS17621.
- BackgroundSamantha J. Reznik, Joseph L. Sanguinetti, William J. Tyler, Chris Daft, John J.B. Allen. (2020) A double-blind pilot study of transcranial ultrasound (TUS) as a five-day intervention: TUS mitigates worry among depressed participants, Neurology, Psychiatry and Brain Research, 37(60-66), ISSN 0941-9500, https://doi.org/10.1016/j.npbr.2020.06.004.
- Background: PubMed 32184714Sanguinetti JL, Hameroff S, Smith EE, Sato T, Daft CMW, Tyler WJ, Allen JJB. Transcranial Focused Ultrasound to the Right Prefrontal Cortex Improves Mood and Alters Functional Connectivity in Humans. Front Hum Neurosci. 2020 Feb 28;14:52. doi: 10.3389/fnhum.2020.00052. eCollection 2020.
- BackgroundSanguinetti, J. L., Smith, E., Allen, J. J. B., Hameroff, S. (2014). Human brain stimulation with transcranial ultrasound (TUS); Potential applications for mental health. In Bioelectromagnetic Medicine. New York, NY: Taylor & Francis.
- Background: PubMed 19171889Sheline YI, Barch DM, Price JL, Rundle MM, Vaishnavi SN, Snyder AZ, Mintun MA, Wang S, Coalson RS, Raichle ME. The default mode network and self-referential processes in depression. Proc Natl Acad Sci U S A. 2009 Feb 10;106(6):1942-7. doi: 10.1073/pnas.0812686106. Epub 2009 Jan 26.
- Derived from this study: PubMed 41641082Schachtner JN, Dahill-Fuchel JF, Zhang D, Allen KE, Bawiec CR, Hollender PJ, Ornellas SB, Konecky SD, Achrol AS, Allen JJB. The effect of non-invasive transcranial focused ultrasound for depression on the default mode network: an open-label pilot trial. Front Psychiatry. 2026 Jan 20;16:1722575. doi: 10.3389/fpsyt.2025.1722575. eCollection 2025.
- Derived from this study: PubMed 40256163Schachtner JN, Dahill-Fuchel JF, Allen KE, Bawiec CR, Hollender PJ, Ornellas SB, Konecky SD, Achrol AS, Allen JJB. Transcranial focused ultrasound targeting the default mode network for the treatment of depression. Front Psychiatry. 2025 Apr 4;16:1451828. doi: 10.3389/fpsyt.2025.1451828. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
John JB Allen, PhD principal investigator
University of Arizona Psychology Department
Jessica N Schachtner, BA principal investigator
University of Arizona Psychology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Non-Invasive Transcranial Focused Ultrasound in people with Depressive Disorder, Major and Depression, run by University of Arizona 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 10 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Beck Depression Inventory - II (BDI-II) (time frame: Before ultrasound treatment, daily after each ultrasound session, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06320028, which also lists 8 linked publications.
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 20 Mar 2024.