Brain zaps for depression? tiny study hopes to lift the fog

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Men and women (non-pregnant) between ages 21 and 70; * DSM-5 diagnosis (assessed by Structured Clinical Interview for DSM-5, SCID-5) of a current major depressive episode (MDE), recurrent or single episode with first episode before age 45, secondary to either nonpsychotic unipolar major depressive disorder (MDD)or bipolar disorder (BD) I; * Chronic illness with current MDE ≥ 24 months duration and/or recurrent illness with at least a total of 4 lifetime episodes (including current episode ≥ 12 months); * For subjects with a bipolar disorder: the last manic or hypomanic episode must have been ≥ 24 months before study enrollment and patients must be maintained on a mood stabilizer (e.g. lithium or another mood stabilizer approved for bipolar disorder). * Treatment resistance (defined by criteria on the Antidepressant Treatment History Form): Failure (i.e. persistence of the major depressive episode) to respond to a minimum of three adequate depression treatments from at least two different treatment categories (e.g. SSRI's, TCA's, other antidepressants, lithium-addition, irreversible MAO-inhibitor, antidepressant augmentation with an atypical antipsychotic medication); also, if diagnosed as bipolar, failure to respond to (or inability to tolerate) a minimum of three treatments approved for bipolar disorder, including lithium and at least one medication FDA-approved for bipolar depression (e.g., olanzapine/fluoxetine combination, quetiapine, lurasidone). * Previous trial of ECT (lifetime) * Symptom Severity: HDRS17 ≥ 21; on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period; * Normal brain MRI within 3 months of surgery; * Stable antidepressant medical regimen for the month preceding surgery * Modified mini-mental state examination (MMSE) score ≥ 27; * Normal thyroid stimulating hormone (TSH) level within 12 months of study entry; * Other medical conditions must be stable for at least 1 year; * Anticipates a stable psychotropic medication regimen in the next 24 months; * Subject must be able to identify a family member, physician, or friend who will participate in the Treatment Contract; * Able and willing to give informed consent. Exclusion Criteria: * Schizophrenia Spectrum or Other Psychotic Disorders (excluding Schizotypal (Personality) Disorder and Substance/Medication Induced Psychotic Disorder); presence of primary or serious (requiring additional treatment) disorders: comorbid obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, bulimia or anorexia, in the last year; * Cluster A or B personality disorder; * Alcohol or substance abuse/dependence within 6 months, excluding nicotine and cannabis provided that participant either a) has a legal prescription or b) is a legal resident of a state where recreational cannabis use is legal; * Current substantial suicidal risk as defined by a plan or clear immediate intent for self-harm, or had a serious suicide attempt within the last year; * Neurological disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication (e.g., Parkinson's disease, MS, stroke); * Any history of seizure disorder or hemorrhagic stroke; * Any medical contraindication to surgery, including infection or coagulopathy; * Participation in another drug, device, or biological trial within 30 days; * Current implanted stimulation devices including cardiac pacemakers, defibrillators, and neurostimulators including spinal cord stimulators, and deep brain stimulators; * Does not have adequate family/friend support as determined by psychological screening and/or interview; * Abnormal brain MRI; * Unable to maintain a stable psychotropic medication regimen in the next 24 months * Pregnant or has plans to become pregnant in the next 24 months.