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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 22 Years
Max Age: 70 Years

Referral Letter Required


Population Exclusion(s)



Brain Stimulation;
Major Depressive Disorder (MDD)

Recruitment Keyword(s)



Unipolar Depression

Investigational Drug(s)


Investigational Device(s)

spECTrum 5000Q stimulator
4X1 High Definition-Electroconvulsive Therapy (HD-ECT) Interface


Device: MRI
Device: MagPro TMS stimulator and coil
Device: MECTA paired with the 4X1 HD-ECT

Supporting Site

National Institute of Mental Health


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.


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


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


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.


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





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

Sponsoring Institution: National Institute of Mental Health

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-Male and female, 22-70 years old

-Use of effective method of birth control for women of childbearing capacity. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test at screening.

-DSM-5 diagnosis of major depressive disorder, confirmed by the structured clinical interview for the DSM 5 (SCID)

-Eligible for ECT, including patients receiving maintenance ECT

-Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document

-Subjects are willing and able to adhere to the intensive treatment schedule and all required study procedures

-On a stable dose of all psychotropic medications (no new medications, discontinuations or dose changes) for 4 weeks prior to baseline assessment and agreement not to change psychotropic medications during the experimental phase (Phase II) of the study, unless advised otherwise by the Investigator.


-Pregnant or nursing women or women who plan to become pregnant during the study period.

-Current or recent (within the past 6 months) substance abuse or dependence (excluding nicotine and caffeine)

-Current serious medical illness, such as high blood pressure, diabetes, heart or lung disease that is not controlled by treatment and/or judged by the investigators to significantly affect the validity of the study or the safety of study participation.

-History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, concussion resulted in loss of consciousness or hospitalization, cranial metal implants that are not safety-compatible with magnetic resonance imaging (MRI) and/or electroconvulsive therapy (ECT), known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator, vagus nerve stimulator)

-Diagnosed with the following conditions (current unless otherwise stated):

--Any other current primary mood, anxiety, or psychotic disorder

--Depression secondary to a general medical condition, or substance-induced

--Psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in the current episode

--Eating disorder (current or within the past year)

--Obsessive compulsive disorder (current or within the past year)

--Post-traumatic stress disorder (current or within the past year)

--ADHD (currently being treated)

--Subjects meeting criteria of any psychiatric illness based upon DSM-5, which in the judgment of the Investigator, may hinder the subjects in completing the procedures required by the study protocol

--Actively suicidal

-Increased risk of complications from seizures, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication at a dose that significantly alters seizure threshold, as determined by the investigators.

-Subjects with a clinically defined neurological disorder including, but not limited to:

--Any condition likely to be associated with increased intracranial pressure

--Space occupying brain lesion

--History of stroke

--Transient ischemic attack within two years

--Cerebral aneurysm


--Mini Mental Status Exam (MMSE) score < 24

--Parkinson s disease

--Huntington s disease

--Multiple sclerosis

-Subjects with any of the following treatment histories:

--Failure to respond to ECT treatment (i.e., consistent with ATHF confidence level 3 or higher) in this or any previous episode

--Lifetime history of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation

--Use of any investigational drug or device within 4 weeks of the screening

-Subjects with:

--intracranial metal that are not safety-compatible with MRI and/or ECT, and/or

--extracranial metal, that are not safety-compatible with MRI and/or ECT

-A history of claustrophobia that may make it difficult for the patient to complete the MRI study or may adversely impact the quality of the images or the interpretation of the findings

-Current visual, auditory, or motor impairment that compromises ability to complete evaluations

-Positive HIV test

-NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy

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Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43.

Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90.

Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65.

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Principal Investigator

Referral Contact

For more information:

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

Paul S. Rohde
National Institute of Mental Health (NIMH)

(301) 435-0885

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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