Schizophrenia Spectrum DisordersNCT07897266
Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
A study testing nVNS (non-invasive vagal nerve stimulation) in people with Schizophrenia Spectrum Disorders, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to learn whether a handheld, non-invasive stimulation device called gammaCore Emerald can change brain activity and thinking skills. Researchers will use MRI scans to measure changes in brain activity after stimulation and compare the results among people with schizophrenia, depression… Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia Spectrum Disorders
- What is being tested?
- nVNS (non-invasive vagal nerve stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age19-55 years old, inclusive
- Sufficient fluency in English to understand testing procedures and provide informed consent
- In one of these three diagnostic groups:
- Schizophrenia Spectrum Disorder (SSD), which can include the diagnoses of Schizophrenia, Schizoaffective Disorder, Unspecified Schizophrenia Spectrum, Schizophreniform Disorder, Brief Psychotic Episode, or Psychotic Disorder NOS (as defined by DSM-V and determined by the Mini International Neuropsychiatric Interview (MINI)
- Unipolar Major Depressive Disorder (MDD) of any subtype. Depressed participants will have a score of >18 on the Montgomery Asberg Depression Rating Scale (MADRS), as defined by DSM-V and determined by the Mini International Neuropsychiatric Interview (MINI)
- Normal healthy controls, individuals with no personal history of any Axis I disorder. Controls will have a MADRS score of <7.
Who cannot join
- Reported pregnancy and/or nursing. A participant may only take part if they are sexually abstinent or using a reliable method of birth control (birth control pills, Norplant, condoms and spermicide).
- Evidence of alcohol or other substance use disorder in the past 3 months
- Diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive deficits due to neurological conditions
- Imminent suicide or homicide risk as determined by the investigator
- Being treated with one of the following medications: benzodiazepines or other CNS depressants.
- No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury.
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- Any of the following disorders are exclusionary: Rheumatoid arthritis; Lupus erythematosus; Autoimmune hepatitis; Autoimmune peripheral neuropathy; Autoimmune pancreatitis; Behcet's disease; Crohn's disease; Autoimmune glomerulonephritis; Grave's disease; Guillain-Barre syndrome; Hashimoto's thyroiditis; Autoimmune polymyositis or polymyalgia; Myasthenia gravis; Narcolepsy; Polyarteritis nodosa; Scleroderma; Sjogren's syndrome; Transverse myelitis; Wegener's granulomatosis; History of seizures (only childhood febrile seizures are allowed)
- Patients with prior exposure to VNS therapy whether using an implantable or external device
- An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
- A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
- An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Exclusion criteria for control subjects include any history of mental illness or psychotropic drug abuse.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35294
Samantha White, 2059349189, swwhite@uabmc.edu
Allison Hudson, 205-996-7171, abeitzel@uabmc.edu
About this study
The purpose of this study is to learn whether a handheld, non-invasive stimulation device called gammaCore Emerald can change brain activity and thinking skills. Researchers will use MRI scans to measure changes in brain activity after stimulation and compare the results among people with schizophrenia, depression, and healthy volunteers.
Read the detailed description
The main aim of this study is to determine whether non-invasive vagal nerve stimulation (nVNS) can modulate large brain networks disrupted in schizophrenia and to understand the timing of connectivity changes caused by stimulation. The central hypothesis that nVNS will (1) reliably activate specific networks in individuals with schizophrenia, (2) partially restore connectivity patterns compared to healthy controls, and (3) produce connectivity changes linked to improvements in cognitive function.
- Conditions
- Schizophrenia Spectrum Disorders
- Being tested
- nVNS (non-invasive vagal nerve stimulation)
- Keywords
- Functional Connectivity in Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nVNS (non-invasive vagal nerve stimulation)Device
hand-held nVNS product for SSD signaling
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia spectrum disorder (SSD) | Experimental | will self-administer hand-held nVNS for 4 minutes; fMRI prior to and following Receives: Device: nVNS (non-invasive vagal nerve stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional Magnetic Resonance Imaging (fMRI)
Effect on functional connectivity
Measured: Within 60 minutes following one-time use of nVNS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Macaluso, University of Alabama at Birmingham
- Investigators
- Matthew W Macaluso, DO, Principal investigator, University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897266
- Sponsor's protocol ID
- IRB-300016667
- Other IDs
- UAB
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Conway CR, Rush AJ, Aaronson ST, Bunker MT, Gordon C, George MS, Riva-Posse P, Allen RM, Nahas Z, Kriedt CL, Zajecka J, Dunner DL, Quevedo J, Sheline Y, Duffy W, Mickey BJ, Stedman M, Alva G, Manu L, Tran Q, Zorumski CF, Macaluso M, Banov M, Cusin C, Bennett JI, Brown H, Way J, Shy O, Lee YL, McAllister-Williams RH, McIntyre RS, Sackeim HA. Durability of the benefit of vagus nerve stimulation in markedly treatment-resistant major depression: a RECOVER trial report. Int J Neuropsychopharmacol. 2026 Jan 6;29(1):pyaf080. doi: 10.1093/ijnp/pyaf080.
PubMed 41529263Conway CR, Aaronson ST, Sackeim HA, George MS, Zajecka J, Bunker MT, Duffy W, Stedman M, Riva-Posse P, Allen RM, Quevedo J, Berger M, Alva G, Malik MA, Dunner DL, Cichowicz I, Banov M, Manu L, Nahas Z, Macaluso M, Mickey BJ, Sheline Y, Kriedt CL, Lee YL, Gordon C, Shy O, Tran Q, Yates L, Rush AJ. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimul. 2025 May-Jun;18(3):676-689. doi: 10.1016/j.brs.2024.12.1191. Epub 2024 Dec 18.
PubMed 39706521Aaronson ST, Conway CR, Gordon C, Lee YL, George MS, Zajecka J, Riva-Posse P, Dunner DL, Macaluso M, Rosenquist PB, Mickey BJ, Sheline YI, Hristidis VC, Brown H, Kriedt CL, Tran Q, Bunker MT, Sackeim HA, Rush AJ. Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder: A RECOVER Trial Report. J Clin Psychiatry. 2025 Jul 14;86(3):25m15850. doi: 10.4088/JCP.25m15850.
PubMed 40673907Zhang Z, Zhuo K, Xiang Q, Sun Y, Suckling J, Wang J, Liu D, Sun Y. Dynamic functional connectivity and its anatomical substrate reveal treatment outcome in first-episode drug-naive schizophrenia. Transl Psychiatry. 2021 May 12;11(1):282. doi: 10.1038/s41398-021-01398-4.
PubMed 33980821Lin X, Deng J, Dong G, Li S, Wu P, Sun H, Liu L, Shi J, Fan Y, Lu L, Li P. Effects of Chronic Pharmacological Treatment on Functional Brain Network Connectivity in Patients with Schizophrenia. Psychiatry Res. 2021 Jan;295:113338. doi: 10.1016/j.psychres.2020.113338. Epub 2020 Aug 5.
PubMed 32768152Li X, Liu Q, Chen Z, Li Y, Yang Y, Wang X, Guo X, Luo B, Zhang Y, Shi H, Zhang L, Su X, Shao M, Song M, Guo S, Fan L, Yue W, Li W, Lv L, Yang Y. Abnormalities of Regional Brain Activity in Patients With Schizophrenia: A Longitudinal Resting-State fMRI Study. Schizophr Bull. 2023 Sep 7;49(5):1336-1344. doi: 10.1093/schbul/sbad054.
PubMed 37083900Chopra S, Francey SM, O'Donoghue B, Sabaroedin K, Arnatkeviciute A, Cropley V, Nelson B, Graham J, Baldwin L, Tahtalian S, Yuen HP, Allott K, Alvarez-Jimenez M, Harrigan S, Pantelis C, Wood SJ, McGorry P, Fornito A. Functional Connectivity in Antipsychotic-Treated and Antipsychotic-Naive Patients With First-Episode Psychosis and Low Risk of Self-harm or Aggression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):994-1004. doi: 10.1001/jamapsychiatry.2021.1422.
PubMed 34160595Cadena EJ, White DM, Kraguljac NV, Reid MA, Jindal R, Pixley RM, Lahti AC. Cognitive control network dysconnectivity and response to antipsychotic treatment in schizophrenia. Schizophr Res. 2019 Feb;204:262-270. doi: 10.1016/j.schres.2018.07.045. Epub 2018 Aug 8.
PubMed 30098853Han SY, Shim L, Lee HJ, Park MK. Transcutaneous auricular vagus nerve stimulation can modulate fronto-parietal brain networks. Front Neurosci. 2024 Jul 18;18:1368754. doi: 10.3389/fnins.2024.1368754. eCollection 2024.
PubMed 39091347Borgmann D, Rigoux L, Kuzmanovic B, Edwin Thanarajah S, Munte TF, Fenselau H, Tittgemeyer M. Technical Note: Modulation of fMRI brainstem responses by transcutaneous vagus nerve stimulation. Neuroimage. 2021 Dec 1;244:118566. doi: 10.1016/j.neuroimage.2021.118566. Epub 2021 Sep 10.
PubMed 34509623Lewine JD, Paulson K, Bangera N, Simon BJ. Exploration of the Impact of Brief Noninvasive Vagal Nerve Stimulation on EEG and Event-Related Potentials. Neuromodulation. 2019 Jul;22(5):564-572. doi: 10.1111/ner.12864. Epub 2018 Oct 4.
PubMed 30288866Macaluso M, Falola M, White S, Wicken C. An open label pilot study of non-invasive vagal nerve stimulation for treatment resistant major depressive disorder. Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 28-31, 2024; Miami Beach, FL.
Sharon O, Fahoum F, Nir Y. Transcutaneous Vagus Nerve Stimulation in Humans Induces Pupil Dilation and Attenuates Alpha Oscillations. J Neurosci. 2021 Jan 13;41(2):320-330. doi: 10.1523/JNEUROSCI.1361-20.2020. Epub 2020 Nov 19.
PubMed 33214317
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT07897266
- Acronym / sponsor ID
- IRB-300016667
- Conditions
- Schizophrenia Spectrum Disorders
- Keywords
- Functional Connectivity in Schizophrenia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (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 purpose of this study is to learn whether a handheld, non-invasive stimulation device called gammaCore Emerald can change brain activity and thinking skills. Researchers will use MRI scans to measure changes in brain activity after stimulation and compare the results among people with schizophrenia, depression, and healthy volunteers.
Detailed description
The main aim of this study is to determine whether non-invasive vagal nerve stimulation (nVNS) can modulate large brain networks disrupted in schizophrenia and to understand the timing of connectivity changes caused by stimulation. The central hypothesis that nVNS will (1) reliably activate specific networks in individuals with schizophrenia, (2) partially restore connectivity patterns compared to healthy controls, and (3) produce connectivity changes linked to improvements in cognitive function.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia spectrum disorder (SSD) | Experimental | Device: nVNS (non-invasive vagal nerve stimulation)will self-administer hand-held nVNS for 4 minutes; fMRI prior to and following |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age19-55 years old, inclusive
- Sufficient fluency in English to understand testing procedures and provide informed consent
- In one of these three diagnostic groups:
Key exclusion criteria (14 listed)
- Reported pregnancy and/or nursing. A participant may only take part if they are sexually abstinent or using a reliable method of birth control (birth control pills, Norplant, condoms and spermicide).
- Evidence of alcohol or other substance use disorder in the past 3 months
- Diagnosis of other primary psychiatric disorder (defined in this case as being the main focus of treatment) as determined by the MINI, such as: bipolar disorder, personality disorders, post-traumatic stress disorder, obsessive-compulsive disorder, dissociative disorders, eating disorder, or cognitive deficits due to neurological conditions
- Imminent suicide or homicide risk as determined by the investigator
- Being treated with one of the following medications: benzodiazepines or other CNS depressants.
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 |
|---|---|---|
| nVNS (non-invasive vagal nerve stimulation)hand-held nVNS product for SSD signaling | Device | schizophrenia spectrum disorder (SSD) |
Primary outcome
functional Magnetic Resonance Imaging (fMRI)
Time frame: Within 60 minutes following one-time use of nVNS.
Effect on functional connectivity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 41529263Conway CR, Rush AJ, Aaronson ST, Bunker MT, Gordon C, George MS, Riva-Posse P, Allen RM, Nahas Z, Kriedt CL, Zajecka J, Dunner DL, Quevedo J, Sheline Y, Duffy W, Mickey BJ, Stedman M, Alva G, Manu L, Tran Q, Zorumski CF, Macaluso M, Banov M, Cusin C, Bennett JI, Brown H, Way J, Shy O, Lee YL, McAllister-Williams RH, McIntyre RS, Sackeim HA. Durability of the benefit of vagus nerve stimulation in markedly treatment-resistant major depression: a RECOVER trial report. Int J Neuropsychopharmacol. 2026 Jan 6;29(1):pyaf080. doi: 10.1093/ijnp/pyaf080.
- Background: PubMed 39706521Conway CR, Aaronson ST, Sackeim HA, George MS, Zajecka J, Bunker MT, Duffy W, Stedman M, Riva-Posse P, Allen RM, Quevedo J, Berger M, Alva G, Malik MA, Dunner DL, Cichowicz I, Banov M, Manu L, Nahas Z, Macaluso M, Mickey BJ, Sheline Y, Kriedt CL, Lee YL, Gordon C, Shy O, Tran Q, Yates L, Rush AJ. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimul. 2025 May-Jun;18(3):676-689. doi: 10.1016/j.brs.2024.12.1191. Epub 2024 Dec 18.
- Background: PubMed 40673907Aaronson ST, Conway CR, Gordon C, Lee YL, George MS, Zajecka J, Riva-Posse P, Dunner DL, Macaluso M, Rosenquist PB, Mickey BJ, Sheline YI, Hristidis VC, Brown H, Kriedt CL, Tran Q, Bunker MT, Sackeim HA, Rush AJ. Prognostic and Prescriptive Predictors of Treatment Response to Adjunctive VNS Therapy in Major Depressive Disorder: A RECOVER Trial Report. J Clin Psychiatry. 2025 Jul 14;86(3):25m15850. doi: 10.4088/JCP.25m15850.
- Background: PubMed 33980821Zhang Z, Zhuo K, Xiang Q, Sun Y, Suckling J, Wang J, Liu D, Sun Y. Dynamic functional connectivity and its anatomical substrate reveal treatment outcome in first-episode drug-naive schizophrenia. Transl Psychiatry. 2021 May 12;11(1):282. doi: 10.1038/s41398-021-01398-4.
- Background: PubMed 32768152Lin X, Deng J, Dong G, Li S, Wu P, Sun H, Liu L, Shi J, Fan Y, Lu L, Li P. Effects of Chronic Pharmacological Treatment on Functional Brain Network Connectivity in Patients with Schizophrenia. Psychiatry Res. 2021 Jan;295:113338. doi: 10.1016/j.psychres.2020.113338. Epub 2020 Aug 5.
- Background: PubMed 37083900Li X, Liu Q, Chen Z, Li Y, Yang Y, Wang X, Guo X, Luo B, Zhang Y, Shi H, Zhang L, Su X, Shao M, Song M, Guo S, Fan L, Yue W, Li W, Lv L, Yang Y. Abnormalities of Regional Brain Activity in Patients With Schizophrenia: A Longitudinal Resting-State fMRI Study. Schizophr Bull. 2023 Sep 7;49(5):1336-1344. doi: 10.1093/schbul/sbad054.
- Background: PubMed 34160595Chopra S, Francey SM, O'Donoghue B, Sabaroedin K, Arnatkeviciute A, Cropley V, Nelson B, Graham J, Baldwin L, Tahtalian S, Yuen HP, Allott K, Alvarez-Jimenez M, Harrigan S, Pantelis C, Wood SJ, McGorry P, Fornito A. Functional Connectivity in Antipsychotic-Treated and Antipsychotic-Naive Patients With First-Episode Psychosis and Low Risk of Self-harm or Aggression: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2021 Sep 1;78(9):994-1004. doi: 10.1001/jamapsychiatry.2021.1422.
- Background: PubMed 30098853Cadena EJ, White DM, Kraguljac NV, Reid MA, Jindal R, Pixley RM, Lahti AC. Cognitive control network dysconnectivity and response to antipsychotic treatment in schizophrenia. Schizophr Res. 2019 Feb;204:262-270. doi: 10.1016/j.schres.2018.07.045. Epub 2018 Aug 8.
- Background: PubMed 39091347Han SY, Shim L, Lee HJ, Park MK. Transcutaneous auricular vagus nerve stimulation can modulate fronto-parietal brain networks. Front Neurosci. 2024 Jul 18;18:1368754. doi: 10.3389/fnins.2024.1368754. eCollection 2024.
- Background: PubMed 34509623Borgmann D, Rigoux L, Kuzmanovic B, Edwin Thanarajah S, Munte TF, Fenselau H, Tittgemeyer M. Technical Note: Modulation of fMRI brainstem responses by transcutaneous vagus nerve stimulation. Neuroimage. 2021 Dec 1;244:118566. doi: 10.1016/j.neuroimage.2021.118566. Epub 2021 Sep 10.
- Background: PubMed 30288866Lewine JD, Paulson K, Bangera N, Simon BJ. Exploration of the Impact of Brief Noninvasive Vagal Nerve Stimulation on EEG and Event-Related Potentials. Neuromodulation. 2019 Jul;22(5):564-572. doi: 10.1111/ner.12864. Epub 2018 Oct 4.
- BackgroundMacaluso M, Falola M, White S, Wicken C. An open label pilot study of non-invasive vagal nerve stimulation for treatment resistant major depressive disorder. Poster presented at: American Society of Clinical Psychopharmacology (ASCP) Annual Meeting; May 28-31, 2024; Miami Beach, FL.
- 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.
Matthew W Macaluso, DO principal investigator
University of Alabama at Birmingham (UAB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nVNS (non-invasive vagal nerve stimulation) in people with Schizophrenia Spectrum Disorders, run by University of Alabama at Birmingham 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 6 inclusion and 14 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha White (205-934-9189, swwhite@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional Magnetic Resonance Imaging (fMRI) (time frame: Within 60 minutes following one-time use of nVNS.). 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 NCT07897266, which also lists 13 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 27 Oct 2026.