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Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
19 Years to 55 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a handheld device called gammaCore Emerald can change brain activity and thinking skills without surgery. Researchers will use MRI brain scans to compare adults ages 19–55 who have schizophrenia-related disorders, major depression, or no history of mental illness.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 19–55 years old.
  • Know enough English to understand the tests and agree to join.
  • Fit one of three groups: a schizophrenia-related disorder, major depression, or a healthy volunteer.
  • For the depression group: have major depression without bipolar disorder and a depression test score above 18.
  • For healthy volunteers: have no personal history of the mental disorders covered by the study and a depression test score below 7.

Who can't join

  • Being pregnant or breastfeeding, or having sex without using reliable birth control.
  • An alcohol or drug use disorder in the past 3 months, or taking benzodiazepines or other drugs that slow brain activity.
  • Another mental disorder that is the main focus of treatment, or an immediate risk of suicide or harming others.
  • A serious brain or nerve disease, major head injury, narcolepsy, or one of the immune system diseases listed by the study. Past seizures also exclude you, except childhood seizures caused by fever.
  • Past vagus nerve stimulation treatment, or surgery to cut this nerve in the neck.
  • An implanted electronic medical device, such as a pacemaker, or metal implanted at or near the neck.
  • Narrowed neck arteries, or a wound, rash, infection, swelling, sore, drug patch, or surgery scar where the device would touch the neck.
  • For healthy volunteers: any history of mental illness or misuse of drugs that affect mood or thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age19-55 years old, inclusive 2. Sufficient fluency in English to understand testing procedures and provide informed consent 3. In one of these three diagnostic groups: 1. 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) 2. 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) 3. Normal healthy controls, individuals with no personal history of any Axis I disorder. Controls will have a MADRS score of \<7. Exclusion Criteria: 1. 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). 2. Evidence of alcohol or other substance use disorder in the past 3 months 3. 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 4. Imminent suicide or homicide risk as determined by the investigator 5. Being treated with one of the following medications: benzodiazepines or other CNS depressants. 6. No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury. 7. 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) 8. Patients with prior exposure to VNS therapy whether using an implantable or external device 9. An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device 10. A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck 11. An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location 12. Patients diagnosed with narrowing of the arteries (carotid atherosclerosis) 13. Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy) 14. Exclusion criteria for control subjects include any history of mental illness or psychotropic drug abuse.

Study sites (1)

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