Focal Electroconvulsive Therapy for Depression

NCT01589315 | Completed Phase 2 Results

• 1 other identifier: FEAST for depression
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Major Depressive Disorder

Keywords

ECT; FEAST; brain stimulation; depression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

FEAST

EXPERIMENTAL

Active right unilateral focal ECT

Device: focal ECT

Interventions

focal ECT DEVICE

FEAST, ECT, unidirectional stimulation

Also known as: FEAST, ultra-brief unidirectional right ECT

FEAST

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 90 years (inclusive)
• Diagnosis of major depressive disorder
• Pretreatment HRSD score ≥ 18
• ECT indicated
• Willing and capable of providing informed consent

You may not qualify if:

• History of schizophrenia,
• schizoaffective disorder,
• other functional psychosis, or
• rapid cycling bipolar disorder
• History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia)
• Alcohol or substance abuse or dependence in the past year (RDC)
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc.
• Unable to tolerate psychotropic washout and no psychotropic medication during the ECT trial, other than lorazepam (up to 3 mg/d PRN)
• ECT in the past six months

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

• 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.

  PMID: 10868319 BACKGROUND

• 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.

  PMID: 14403427 BACKGROUND

• 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.

  PMID: 23518262 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Mark S. George, MD
• Organization: Medical University of South Carolina

georgem@musc.edu

1843876 5142

Study Officials

• Ziad Nahas, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: May 1, 2012
• Study Start: January 1, 2007
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: August 20, 2019
• Results First Posted: August 20, 2019

Record last verified: 2019-08

Locations

US (1)