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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895658
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Brief 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.

Sponsoring Institution: National Institute of Mental Health

...


Condition or disease Intervention/treatment Phase
Unipolar Depression Device: MRI Device: MagPro TMS stimulator and coil Device: MECTA paired with the 4X1 HD-ECT Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
Estimated Study Start Date : June 21, 2021
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: ECT
ECT treatment, within subject crossover
Device: MECTA paired with the 4X1 HD-ECT
Multichannel Stimulation Interface (Model 4X1E1)

Experimental: MRI
Structural and functional neuroimaging pre and post ECT treatment
Device: MRI
Structural and functional neuroimaging pre and post ECT treatment

Experimental: TMS
Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment
Device: MagPro TMS stimulator and coil
Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment




Primary Outcome Measures :
  1. Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events [ Time Frame: ongoing ]
    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 :
  1. 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 [ Time Frame: ongoing ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • 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 MINI
  • 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

EXCLUSION CRITERIA:

  • Pregnant or nursing women or women who plan to become pregnant.
  • 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, 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 Axis I 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 seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication at a dose that significantly alters the 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
    • Dementia
    • 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
  • MRI contraindications (any metal in the body, claustrophobia, etc.)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895658


Contacts
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Contact: Nadia Mustafa (301) 480-4244 nadia.mustafa@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sarah H Lisanby, M.D. National Institute of Mental Health (NIMH)
Additional Information:
Publications:
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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT03895658    
Other Study ID Numbers: 190073
19-M-0073
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: May 11, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Brain Stimulation
Neurocognitive
Major Depressive Disorder (MDD)
Additional relevant MeSH terms:
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Seizures
Depressive Disorder
Neurologic Manifestations
Nervous System Diseases
Mood Disorders
Mental Disorders