Focal Electroconvulsive Therapy for Depression

Study Summary

This pilot, open label investigation evaluates the safety and efficacy of a new form of electroconvulsive therapy (ECT). Both the efficacy and adverse cognitive effects of ECT are highly contingent on the intracerebral current paths and current density of the ECT stimulus. However, the impedance of the skull and individual differences in skull anatomy severely limit the spatial targeting of stimulation, and create marked individual differences in intracerebral current density. To address these problems, the investigators are exploring various means of overcoming this limitation. An approach is to modify the electrical stimulus to induce focal seizures. The most common methods of ECT administration in the US use a bidirectional, constant current, brief pulse, with large (approximately 3 sq. in. surface area) and identically sized and shaped electrodes. In contrast, in this protocol the investigators have coupled unidirectional current flow with an electrode geometry involving a small and large electrode that differ by more than 3:1 in surface area. Unidirectional currents were widely used in ECT during the, 1940's and continue to be used in European and American devices today. Transcranial electrical stimulation can be made focal by stimulating with an anode-cathode arrangement, with the electrodes differing in surface area. The investigators have shown in nonhuman primates the capacity to produce focal frontal seizure induction under conditions when a unidirectional current flows from a small anterior anode (placed on the forehead over the nasion) to a large posterior cathode just anterior to the motor strip. Furthermore, the investigators expect that some, if not all, of these seizures do not result in motor convulsions. Thirty outpatients referred for ECT will participate. Relative to concurrent reference data from our ongoing ECT protocols, the investigators hypothesize that acute and subacute adverse cognitive effects of FEAST will be substantially less than

Primary Outcome

The number of treatment sessions is not fixed and could extend up to 12 provided that patients show continued improvement and tolerate the treatment. With 3 FEAST sessions per week, the course may take up to 12 weeks to be completed. The Hamilton Rating Scale for Depression is a widely used clinician administered rating.Scores range from (Min) 0 to (Max) 52. Higher score means worse depression. The definition of remission was a Ham Depression Score (24 item) of \< or equal to 10.

Conditions Studied

Interventions

• DEVICE focal ECT

Study Locations (1)