Loading search results
FEAST
Focal Electrical Administered Seizure Therapy (FEAST) for Major Depression
Sponsor study identifier
interventional
17
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2016
Actual (reported)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 those in patients receiving state-of-the art ECT, but with a traditional bidirectional, nonfocal stimulus. The investigators also hypothesize that the majority of patients will remit with FEAST. Thus, by improving the efficiency of the ECT stimulus with the switch to unidirectional current and the use of a new electrode geometry, the investigators expect to be able to induce focal seizures. The investigators hypothesize that this pilot study will provide evidence that this treatment is superior to traditional ECT in having lower dosing requirements and a superior side effect profile.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
April 25, 2012
Actual (reported)May 1, 2012
Actual (reported)August 2015
Actual (reported)August 2016
Actual (reported)August 20, 2019
Actual (reported)Remission Based on HDRS, Hamilton Depression Rating Scale, 24 Item.
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.
up to 4 weeks
Active right unilateral focal ECT
FEAST, ECT, unidirectional stimulation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Sackeim HA. Memory and ECT: from polarization to reconciliation. J ECT. 2000 Jun;16(2):87-96. doi: 10.1097/00124509-200006000-00001. No abstract available.
HOVORKA EJ, SCHUMSKY DA, WORK MS. Electroconvulsive thresholds as related to stimulus parameters of unidirectional ECS. J Comp Physiol Psychol. 1960 Aug;53:412-4. doi: 10.1037/h0041786. No abstract available.
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. Epub 2013 Mar 16.
Ziad Nahas, MD
Medical University of South Carolina
17 participants (actual enrollment reported by the registry).
First Submitted
April 25, 2012
First Posted
May 1, 2012
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2016
Actual (reported)Last Updated
August 20, 2019
Results First Posted
August 20, 2019
Record last verified: 2019-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: