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Procedure

Enhanced ECT for Depression

N/A
Recruiting
Led By Ziad Nahas, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is testing a new way to do ECT that may reduce negative side effects like memory loss.

Who is the study for?
This trial is for adults with major depressive disorder who have a significant level of depression and are deemed suitable for ECT by their doctor. They must be able to consent to treatment. Excluded are those with recent substance abuse, certain psychiatric or neurological conditions, pregnancy, or recent ECT.Check my eligibility
What is being tested?
The study tests FEAST, an alternative form of ECT aimed at reducing memory loss by targeting the Prefrontal Cortex more precisely using adjusted electrodes on one side of the head. The procedure includes anesthesia and recovery monitoring similar to standard ECT.See study design
What are the potential side effects?
While aiming to reduce negative effects like memory loss associated with traditional ECT methods, potential side effects may still include confusion post-treatment, headaches, muscle soreness or temporary memory disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Seizure Drive Markers on EEG
Seizure characteristics by motor observation
Seizure characteristics on EEG
Secondary outcome measures
Amnestic Side Effects
Change in Hamilton Depression Rating Score (HDRS)
Change in Inventory for Depressive Symptoms - Self Report (IDS-SR) Score
+1 more

Side effects data

From 2019 Phase 2 & 3 trial • 48 Patients • NCT02535572
80%
headache
50%
muscle ache
35%
Nausea
5%
prolonged seizure
5%
postictal agitation),
100%
80%
60%
40%
20%
0%
Study treatment Arm
FEAST
RUL UB

Trial Design

2Treatment groups
Experimental Treatment
Group I: B: RP FEASTExperimental Treatment2 Interventions
Focally Electrically-administered Seizure Therapy (FEAST) with Reversed Polarity (RP) utilizes the same electrode placement as FEAST but a reversed directionality of current flow.
Group II: A: FEASTExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FEAST
2015
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,476 Total Patients Enrolled
Ziad Nahas, MDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
32 Total Patients Enrolled

Media Library

Enhanced Spatial Targeting in ECT Utilizing FEAST (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04099342 — N/A
Major Depressive Disorder Research Study Groups: B: RP FEAST, A: FEAST
Major Depressive Disorder Clinical Trial 2023: Enhanced Spatial Targeting in ECT Utilizing FEAST Highlights & Side Effects. Trial Name: NCT04099342 — N/A
Enhanced Spatial Targeting in ECT Utilizing FEAST (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04099342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are actively involved in this research?

"Absolutely. Records on clinicaltrials.gov highlight that this medical study, first posted on April 1st 2022, is actively recruiting participants from a single site with the intention of enrolling 20 patients in total."

Answered by AI

Is eligibility for this clinical experiment open to me?

"Candidates need to meet the criteria of unipolar depression and fall within an age range between 18-90 in order for them to be considered for this medical trial. Currently, there is space for 20 participants total."

Answered by AI

Does this clinical trial accept individuals aged 55 or older?

"Eligible participants for this clinical trial should be aged 18 to 90. Additionally, there are 1 trials that cater exclusively to underage applicants and 83 specifically targeting elderly patients."

Answered by AI

Is enrollment for this research project still available?

"According to the clinicaltrials.gov page, this medical trial is still enrolling participants as of May 12th 2022. The study was initially posted on April 1st 2020 and has since been routinely updated."

Answered by AI

What is the purpose of this medical research endeavor?

"The 8 week trial's primary outcome is to assess Seizure Drive Markers on EEG. Additionally, the Hamilton Depression Rating Score (HDRS), Inventory for Depressive Symptoms - Self Report (IDS-SR) Score and Time to Reorientation will be measured as secondary outcomes. HDRS involves a 24-item interview where 17 items are scored from 0 to 4 while 9 are rated between 0 and 2; with a final range of scores ranging from 0 representing normal functioning up to 22 indicating severe depression. IDS-SR similarly consists of 30 questions that can each receive an answer value from 1 meaning no impairment or 3 signifying grave"

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Enhanced Spatial Targeting in ECT Utilizing FEAST
2022. "Enhanced Spatial Targeting in ECT Utilizing FEAST". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04099342.
~5 spots leftby Dec 2024
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