Transcranial Alternating Current Stimulation for Major Depressive Disorder

Central Hypothesis: Non-invasive brain stimulation that suppresses alpha oscillation reduces
cortical hyperactivity and causes a clinical improvement

Aim 1: To conduct a pilot clinical trial to establish feasibility and to collect first
effectiveness data for the use of tACS to renormalize pathological alpha oscillations in the
dorsolateral prefrontal cortex (dl-pfc) of unmedicated patients with MDD by comparing MADRS
scores from baseline and one month follow up.

Aim 2: Compare alpha oscillation power from resting state EEG recordings on the first and
last day of stimulation. Collect EEG data at the one month follow up visit using this data to
analyze alpha frequency activity as a pilot study for derivation of EEG biomarkers.

Inclusion Criteria:

- Male or female, 18-65 years old

- Diagnostic and Statistical Manual of Mental Disorder, 4th edition (DSM-IV) diagnosis
of MDD; unipolar, non-psychotic

- Hamilton Depression Rating Scale score >8

- Capacity to understand all relevant risks and potential benefits of the study
(informed consent)

- Meet criteria for low suicide risk

- Willing to comply with all study procedures and be available to do so for the duration
of the study

- Women of reproductive potential must use highly effective contraception

Exclusion Criteria:

- DSM-IV diagnosis of alcohol of substance abuse (other than nicotine) within the last
month or a DSM-IV diagnosis of alcohol or substance dependence (other than nicotine)
within the last 6 months

- Current use of benzodiazepines or anti-epileptic drugs

- Current axis I mood, or psychotic disorder other than major depressive disorder

- Lifetime comorbid psychiatric bipolar or psychotic disorder

- Eating disorder (current or within the past 6 months)

- Obsessive-compulsive disorder (lifetime)

- Post traumatic stress disorder (PTSD; current or within the last 6 months)

- Attention Deficit Hyperactivity Disorder (ADHD; currently under treatment)

- Anything that, in the opinion of the investigator, would place the participant at
increased risk or preclude the participant's full compliance with or completion of the
study

- Neurological disorders, including but not limited to history of seizures (except
childhood febrile seizures and ECT induced seizures), dementia, history of stroke,
Parkinson's disease, multiple sclerosis, cerebral aneurism

- Medical or neurological illness (unstable cardiac disease, AIDS, malignancy, liver or
renal impairment) or treatment for a medical disorder that could interfere with study
participation

- History of traumatic brain injury, reoccurring seizures or later cognitive
rehabilitation, or causing cognitive sequelae

- Prior brain surgery

- Any brain devices/implants, including cochlear implants and aneurysm clips

- Co-morbid neurological condition (i.e. seizure disorder, brain tumor)

- Non English speakers

- Pregnancy, nursing, or if female and fertile, unwilling to use appropriate birth
control measures during study participation