The Effect of Transcranial Direct Current Stimulation on Cognitive Side Effects of Electroconvulsive Therapy

This is a prospective, random assignment, double blind, parallel group study with an adaptive
design comparing the efficacy of tDCS performed during the course of ECT to that of sham tDCS
in patients with a major depressive episode being treated with ECT. The investigators intend
to recruit patients who are scheduled to receive an acute course of ECT. Patients who are
able and willing to provide written informed consent, and who meet study criteria when
screened, will be randomly assigned on a 1:1 ratio to receive a course of real tDCS or sham
tDCS. Subjects will receive a standard acute course of bifrontal ECT (3X/week) and depressive
symptomatology will be monitored with the Hamilton Rating Scale for Depression (HRSD-24)
before each treatment.

The primary outcome will be change in cognition from baseline to end of study. The
investigators will monitor cognitive changes before and after each ECT treatment, at the end
of the treatment course and two months after the last treatment.

Secondary outcome will be the number of treatments needed to achieve remission. Remission is
defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD
total score does not change > 3 points or remains < 6 at the last two consecutive treatments.
In addition, the investigators will collect data on other treatment parameters such as
seizure duration, electroencephalogram (EEG) morphology as well as hemodynamic changes.

Inclusion Criteria:

- Subjects 18 years of age and above;

- Diagnosis of Major Depression confirmed by Structured Clinical Interview for
Diagnostic and Statistical Manual IV (SCID-IV) interview;

- ECT is clinically indicated;

- Patient is competent to provide informed consent;

Exclusion Criteria:

- Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder or any other
primary psychotic disorder as well as Bipolar Disorder, as defined in the DSM-IV;

- Current diagnosis of delirium or any major or minor neurocognitive disorder;

- Diagnosis of Mental Retardation;

- Limited English proficiency;

- Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two
standard deviations below the age- and education-adjusted mean, whichever is less;

- Skin lesions at the site of electrodes and any documented head or neck dermatological
disorder;

- Person with any kind of neurostimulator, an electrically, magnetically or mechanically
activated implant (including cardiac pacemaker), an intracerebral vascular clip, or
any other electrically sensitive support system;

- Any active general medical condition or central nervous system (CNS) disease which can
affect cognition or response to treatment;

- A history of medication-resistant epilepsy in the family, and/or past history of
seizures or unexplained spells of loss of consciousness during the previous 36 months

- Current (within the past three months) diagnosis of active substance dependence, or
active substance abuse within the past week, as determined by interview and chart
review.

- Active suicidal ideation, as measured by scores of 3 or more on item 3 of the HRSD;

- ECT within six months;

- The presence of any known or suspected contraindication to methohexital including but
not limited to known allergic reactions to these agents, uncontrolled hypertension,
arrhythmia, severe coronary artery disease and porphyria;

- Pregnancy as determined by interview and blood work done for ECT workup;

- Women who are breastfeed as determined by self-report;

- Status 4 or greater according to the criteria of the American Society of
Anesthesiologists.