Enhanced Spatial Targeting in ECT Utilizing FEAST

NCT04099342 | Suspended DMC FDA Device

• 1 other identifier: PSYCH-2019-27591
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find an alternative version of ECT that reduces the negative side effects (mainly memory loss) while still providing patients with relief from depressive symptoms. Previous forms of ECT may use Bilateral (electrodes on both sides of the head) or Right Unilateral (RUL) (electrodes on one side of the head). Our research focuses on adjusting the placement of electrodes on one side of the head in order to better stimulate the Prefrontal Cortex (PFC) of the brain. By more specifically targeting the PFC, it is predicted that participants will receive the same benefit as ECT but will have fewer negative side effects after the treatment, mainly less memory loss. All other aspects of the treatment will be similar to regular, clinical ECT, including anesthesia and recovery monitoring. To accomplish this stimulation, an adjusted MECTA Spectrum 5000Q device will be used. If successful, this research study will demonstrate a way to improve ECT procedures for all patients suffering from Major Depressive Disorder by minimizing side effects and maintaining or improving efficacy.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (3)

• Seizure Drive Markers on EEG

  Electrophysiological markers of the induced seizure will be captured with a 6-lead EEG placed over bilateral frontal, temporal and parietal lobes. Raw data will be collected in MicroVolts while the analysis will summarize connectivity measures. Right prefrontal activity and seizure drive will be contrasted to other regions from which EEG is recorded, to describe the focality of FEAST-induced seizures.

  8 weeks

• Seizure characteristics on EEG

  Length of induced seizures is measured by EEG and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed.

  8 weeks

• Seizure characteristics by motor observation

  Length of induced seizures is measured by motor observation and recorded in seconds. Spectra powers, global and regional intensity will also be analyzed.

  8 weeks

Secondary Outcomes (4)

• Change in Hamilton Depression Rating Score (HDRS)

  8 weeks

• Change in Inventory for Depressive Symptoms - Self Report (IDS-SR) Score

  8 weeks

• Time to Reorientation

  8 weeks

• Amnestic Side Effects

  8 weeks

Study Arms (2)

A: FEAST

EXPERIMENTAL

Focally Electrically-administered Seizure Therapy (FEAST) is a form of Electroconvulsive therapy (ECT) that combines unidirectional stimulation, control of polarity, and an asymmetrical electrode configuration.

Device: FEAST; Device: FEAST RP

B: RP FEAST

EXPERIMENTAL

Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Polarity (RP) utilizes the same electrode placement as FEAST but a reversed directionality of current flow.

Device: FEAST; Device: FEAST RP

Interventions

FEAST DEVICE

FEAST with standard electrode configuration and current flow

A: FEAST; B: RP FEAST

FEAST RP DEVICE

FEAST with standard electrode configuration and reversed current flow

A: FEAST; B: RP FEAST

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of major depressive disorder using MINI-7 to derive RDC; DSM-IV
• Pretreatment HRSD score greater than or equal to 18
• ECT indicated by physician evaluation
• Willing and capable of providing informed consent as determined by physician evaluation

You may not qualify if:

• History of schizophrenia, schizoaffective disorder, other functional psychosis, or rapid cycling bipolar disorder as determined by MINI-7; rapid cycling defined as greater than or equal to four episodes in past year
• History of neurological illness or insult other than conditions associated with psychotropic exposure (e.g., tardive dyskinesia) determined by physician evaluation and medical history
• Alcohol or substance abuse or dependence in the past year (RDC) determined by physician evaluation
• Secondary diagnosis of a delirium, dementia, or amnestic disorder (DSM-IV), pregnancy, or epilepsy determined by physician evaluation
• Requires especially rapid antidepressant response due to suicidality, psychosis, inanition, psychosocial obligations, etc. determined by physician evaluation
• ECT in the past six months determined by physician evaluation and medical history
• Pregnancy as determined by urine pregnancy test and clinical interview

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ziad Nahas, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 23, 2019
• Study Start: June 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)