NCT03895658

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

Withdrawn Phase 1 Last updated 27 February 2025

What this trial tests

Phase 1 trial testing MRI in Unipolar Depression. Withdrawn.

Timeline

26 February 2025

Primary endpoint
26 February 2025

26 February 2025

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	crossover
Masking	single
Primary purpose	treatment
Start date	26 February 2025
Primary completion	26 February 2025
Estimated completion	26 February 2025
Sites	1 location across United States

Drugs / interventions tested

• MRI — full drug profile →
• MagPro TMS stimulator and coil
• Thymatron (R) System IV paired with 4X1 HDECT

Conditions studied

• Unipolar Depression — all drugs for Unipolar Depression →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

Adults 22 to 70, any sex, with Unipolar Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Glioma: molecular signature and crossroads with tumor microenvironment.
   Barthel L, Hadamitzky M, Dammann P, Schedlowski M, et al · · 2022 · cited 156× · PMID 34687436 · DOI 10.1007/s10555-021-09997-9
2. How electroconvulsive therapy works in the treatment of depression: is it the seizure, the electricity, or both?
   Deng ZD, Robins PL, Regenold W, Rohde P, et al · · 2024 · cited 46× · PMID 37488281 · DOI 10.1038/s41386-023-01677-2
3. Electric field strength induced by electroconvulsive therapy is associated with clinical outcome.
   Fridgeirsson EA, Deng ZD, Denys D, van Waarde JA, et al · · 2021 · cited 30× · PMID 33588322 · DOI 10.1016/j.nicl.2021.102581