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Procedure

iLAST for Depression

Phase 1
Recruiting
Led By Sarah H Lisanby, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
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 ongoing
Awards & highlights

Study Summary

This trial is testing a new, safer way to give electroconvulsive therapy (ECT) called iLAST. ECT is used to treat people with severe depression and can cause memory loss as a side effect. The trial will last up to 20 weeks, during which participants will have various tests to see if iLAST is safe and feasible.

Who is the study for?
Adults aged 22-70 with major depressive disorder eligible for ECT can join this trial. They must understand the study, consent to it, follow a strict treatment schedule, and not change their psychiatric medications during Phase II. Women of childbearing age should use birth control and have a negative pregnancy test.Check my eligibility
What is being tested?
The iLAST method is being tested as an alternative to traditional ECT for treating severe depression. It involves MRI scans, brain activity recordings (MEG), electrical stimulation (TMS), nerve function tests (SEP), and interviews about mood and side effects over three phases lasting up to 20 weeks.See study design
What are the potential side effects?
Potential side effects may include memory loss similar to standard ECT, discomfort or risks from anesthesia during seizures induced by iLAST sessions, headaches or scalp discomfort from TMS, and general discomfort from participating in various testing procedures like MRIs.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
Secondary outcome measures
Neurocognitive battery known to be sensitive to the cognitive effects of ECT, with alternative versions to avoid practice effects; and, Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derive...

Trial Design

3Treatment groups
Experimental Treatment
Group I: TMSExperimental Treatment1 Intervention
Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment
Group II: MRIExperimental Treatment1 Intervention
Structural and functional neuroimaging pre and post ECT treatment
Group III: ECTExperimental Treatment1 Intervention
ECT treatment, Within subject cross-over
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,785 Previous Clinical Trials
2,689,736 Total Patients Enrolled
Sarah H Lisanby, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
5 Previous Clinical Trials
434 Total Patients Enrolled

Media Library

Individualized Low Amplitude Seizure Therapy (iLAST) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03895658 — Phase 1
Major Depressive Disorder Research Study Groups: TMS, ECT, MRI
Major Depressive Disorder Clinical Trial 2023: Individualized Low Amplitude Seizure Therapy (iLAST) Highlights & Side Effects. Trial Name: NCT03895658 — Phase 1
Individualized Low Amplitude Seizure Therapy (iLAST) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03895658 — Phase 1

Frequently Asked Questions

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

Does this research project include participants who are 55 years and older?

"This trial is only open to those aged between 22 and 70. For minors (under 18) there are currently 144 clinical studies, while 647 trials exist for seniors (over 65)."

Answered by AI

How many participants have been recruited for this research project?

"Affirmative. Based on information available from clinicaltrials.gov, this research has been taking applications since November 29th 2022 and is still accepting them as of the last edit made on November 23rd 2022. It requires 20 participants to be recruited from a solitary site."

Answered by AI

Are there any vacancies remaining to join this clinical trial?

"The clinical trial is still recruiting, as evidenced by the recent updates to its listing on clinicaltrials.gov that occured on November 23rd 2022. This medical study was originally posted just a week prior - Nov 29th 2022."

Answered by AI

How deleterious are the effects of combining MECTA and 4X1 HD-ECT for humans?

"The combination of MECTA and 4X1 HD-ECT is still in the nascent stages, so Power's team graded its safety a 1. This rating is based on limited evidence regarding efficacy and protection from harm."

Answered by AI

On what criteria are individuals selected to participate in this experiment?

"This clinical trial has capacity for 20 individuals suffering from seizures aged between 22 and 70. The prerequisites to be eligible include: both genders, 4 weeks of steady dosing with psychotropic medications, usage of reliable contraception in females able to bear children, a DSM-5 diagnosis of major depressive disorder verified via the SCID interview, and assent by participants to all examinations and tests involved."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
Archives of General PsychiatryJournal
The Effects of Electroconvulsive Therapy on Memory of Autobiographical and Public Events
Lisanby, S. H.. 2000. “The Effects of Electroconvulsive Therapy on Memory of Autobiographical and Public Events”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.57.6.581.
NeuropsychopharmacologyJournal
Safety and Feasibility of Magnetic Seizure Therapy (MST) in Major Depression: Randomized Within-subject Comparison with Electroconvulsive Therapy
Lisanby, Sarah H, Bruce Luber, Thomas E Schlaepfer, and Harold A Sackeim. 2003. “Safety and Feasibility of Magnetic Seizure Therapy (MST) in Major Depression: Randomized Within-subject Comparison with Electroconvulsive Therapy”. Neuropsychopharmacology. Springer Science and Business Media LLC. doi:10.1038/sj.npp.1300229.
The Journal of ECTJournal
Quantitative EEG During Seizures Induced by Electroconvulsive Therapy: Relations to Treatment Modality and Clinical Features. II. Topographic Analyses
Luber, Bruce, Mitchell S. Nobler, James R. Moeller, Gary P. Katzman, Joan Prudic, D. P. Devanand, Gabriel S. Dichter, and Harold A. Sackeim. 2000. “Quantitative EEG During Seizures Induced by Electroconvulsive Therapy: Relations to Treatment Modality and Clinical Features. II. Topographic Analyses”. The Journal of ECT. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00124509-200009000-00003.
clinicaltrials.govStudy
Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
2024. "Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03895658.
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