Enhanced Spatial Targeting in ECT Utilizing Focally Electrically-administered Seizure Therapy (FEAST)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Ziad Nahas, MD
znahas@umn.edu
952-525-4505
Backup
Rachel Johnson, PhD
ipl@umn.edu
952-525-4505
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: A: FEAST
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.
Experimental: B: RP FEAST
Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Polarity (RP) utilizes the same electrode placement as FEAST but a reversed directionality of current flow.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov