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Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)

NCT03895658 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-02-27

No results posted yet for this study

Summary

Background:

Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST.

Objective:

To see if iLAST is safe and feasible in treating depression.

Eligibility:

People ages 22 70 years old who have major depressive disorder and are eligible for ECT

Design:

Participants will be screened under protocol 01-M-0254. This includes:

Medical and psychiatric history and exam

Blood and urine tests

Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks.

Phase I will last 1 week. It includes:

MRI: Participants will lie in a scanner that takes pictures of the body

MEG: A cone over the participant s head will record brain activity.

TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity.

SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function.

Phase II will last 2 and a half weeks. It includes:

Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT.

EEG: A small electrode placed on the participant s scalp will record brain waves.

Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded.

TMS

Phase III will last at least 1 week. It will include:

MRI

EEG

TMS

MEG

Standard ECT if needed. Participants will have sessions every other day, 3 times a week.

Conditions

  • Unipolar Depression

Interventions

DEVICE

MRI

Structural and functional neuroimaging pre and post ECT treatment

DEVICE

MagPro TMS stimulator and coil

Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment

DEVICE

Thymatron (R) System IV paired with 4X1 HDECT

Multi-Channel Stimulation Interface (Model 4X1 HDECT)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Sarah H Lisanby, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2025-02-26
Completion
2025-02-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03895658 on ClinicalTrials.gov