Focal Electrically-Administered Seizure Therapy (FEAST) Studies at Two Enrolling Sites to Further Test and Refine the Treatment
Focal Electrically-Administered Seizure Therapy (FEAST): Studies at Two Enrolling Sites to Further Test and Refine the Treatment
This open label investigation further evaluates the safety, efficacy and potential
mechanisms of action of a new form of electroconvulsive therapy (ECT). The investigators
have recently completed preliminary open-label studies with FEAST, first at Columbia
University, and then at the Medical University of South Carolina in Charleston (Nahas et
al., 2013b). The investigators have published the outcomes of the first 17 patients studied.
One patient withdrew from the study after a single titration session. After the course of
FEAST (median 10 sessions), there was a 46.1 + 35.5% improvement in Hamilton Rating Scale
for Depression (HRSD24) scores compared to baseline (33.1 + 6.8, 16.8 + 10.9; P < 0.0001).
Eight of 16 patients met response criteria (≥50% decrease in HRSD24) and 5/16 met remission
criteria (HRSD24≤10). Patients achieved full re-orientation (4 of 5 items correct) in 5.5 +
6.4 min (median time = 3.6 min), timed from when their eyes first opened after treatment.
The investigators have now studied 18 more patients (see results below), and we are
completing the study in the original IDE with another two more patients still to enroll.
This work allowed us to refine the treatment. For example, the investigators selectively
modified the electrode geometry to decrease interelectrode resistance. Additionally the
investigators modified the titration schedule, now only administering a standard 800 ma
ultrabrief pulse, and thus no longer titrating in the current domain.
In this next proposed trial we will continue to gather efficacy and safety data, and compare
these to a parallel non-randomized group receiving ECT standard of care.
ECT is typically delivered in a dynamically adaptive manner, with each person having a
different number of treatments, averaging between 8-12 treatment over 4-5 weeks. We thus
have to use imprecise time points such as 'at the end of the acute treatment course' rather
than specified dates or visits.
This study will provide preliminary evaluation of the following:
1. Further characterization of the efficacy of FEAST and the safety of the treatment.
1. The primary efficacy measure will be the 24-item Hamilton Rating Scale for
Depression. The changes in these scores from before to immediately following the
treatment course (typically after 4 weeks) will be compared in patients treated
with the FEAST methodology and matched to nonrandomized patients at our facilities
who were treated with conventional ECT methods (ultrabrief right unilateral [RUL]
2. Acute and subacute cognitive side effects following FEAST will be assessed with a
brief neuropsychological battery. The primary acute measures will be the time to
return of orientation following seizure induction. The primary subacute measures
will be assessment of retrograde amnesia for autobiographical information. The
neuropsychological measures will be compared in the patients treated with the
FEAST methodology (under this IDE) and matched (but nonrandomized) patients who
are treated with conventional ECT methods (also covered under this IDE).
3. Safety will also be determined by examining the number and frequency of serious
adverse advents and adverse events.
2. Characterization of the focal nature of the seizure onset with FEAST and RUL ECT. We
will use two main methods to address the issue of focality.
1. Resting state fMRI before and after a course of FEAST (or conventional RUL ECT).
We will address whether FEAST causes changes in hyper connected prefrontal
cortical subcortical networks, and whether such an effect is more restricted to
prefrontal cortex with FEAST relative to conventional RUL ECT.
2. Peri-ictal EEG acquired immediately before, during and immediately after the FEAST
seizure. We will acquire this in all patients at all treatment sessions. Again,
for comparison, we will use identical EEG acquisition methods in patients treated
with conventional RUL ECT.
Medical University of South Carolina
Medical University of South Carolina, Augusta University
Nahas Z, Short B, Burns C, Archer M, Schmidt M, Prudic J, Nobler MS, Devanand DP, Fitzsimons L, Lisanby SH, Payne N, Perera T, George MS, Sackeim HA. A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST]. Brain Stimul. 2013 May;6(3):403-8. doi: 10.1016/j.brs.2013.03.004.