CES for the Treatment of GAD in Young Adults

Exclusion Criteria

• •Time-frames are determined relative to the screening visit.
• •Current (any) or previous (\> 7 stimulation sessions in last 6 weeks) use of a CES device.
• •Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.
• •Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or within 60 days prior to screening visit).
• •Implanted medical device that uses electricity anywhere in the body.
• •Diagnosis (based on MINI) of bipolar I or II (past or current), moderate or severe alcohol use disorder (within 12 months prior to screening visit), moderate or severe (non-alcohol) substance use disorder (within 12 months prior to screening visit), psychotic disorder (current or lifetime), major depressive disorder with psychotic features, bipolar I with psychotic features, anorexia nervosa.
• •Epilepsy (current or history). History of febrile childhood seizures and non-epileptic seizures are allowed.
• •Pregnant or breast-feeding.
• •Enrollment in clinical trial for any condition (current or within 60 days prior to screening visit).
• •Hospitalization for any reason (current or past 2 weeks).
• •Self-harming behaviors (current or within two years prior to screening visit).
• •Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (C-SSRS).
• •Known cardiac abnormality or clinically significant heart disease.
• •Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.