Handheld Vagus Nerve Stimulation and Brain Activity on MRI in Schizophrenia
Tests a handheld nerve stimulator's effect on brain activity in people with schizophrenia.
Plain-language title generated from the registry record
Registry title: Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
Key facts
- Where
- Birmingham, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 19 and 55 years old?
Source: NCT07897266, who can take part
Where in United States
- University of Alabama at Birmingham (UAB)Birmingham, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT07897266
- Record updated
- 27 October 2026
- Original description
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 full original descriptionShow less
Non-Invasive Vagus Nerve Stimulation as a Probe to Map Functional Connectivity in Schizophrenia Using Functional Magnetic Resonance Imaging
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.
Inclusion: 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.
Exclusion: Being treated with one of the following medications: benzodiazepines or other CNS depressants; 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; Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy); 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; No clinically significant neurological disease based on medical history (e.g., epilepsy) or significant head injury; 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); An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location; Exclusion criteria for control subjects include any history of mental illness or psychotropic drug abuse; 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); Imminent suicide or homicide risk as determined by the investigator; A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck; Patients diagnosed with narrowing of the arteries (carotid atherosclerosis).