Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
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|ClinicalTrials.gov Identifier: NCT03895658|
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : May 17, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Unipolar Depression||Device: Multichannel Stimulation Interface||Phase 1|
The primary aim of the current protocol is to evaluate the safety and feasibility of iLAST in 10 adults with major depressive episode (unipolar) eligible for ECT. We hypothesize that both iLAST will result in superior neurocognitive outcomes than conventional ECT. In addition, we will evaluate the feasibility of alternative methods to individualize the pulse amplitude. The approach to individualizing pulse amplitude is to apply trains of pulses of increasing amplitude until a seizure is induced. To be practical in the clinical setting, the motor threshold (MT) procedure will be completed rapidly to minimize time under anesthesia. To this end, we will evaluate a rapid- estimation motor thresholding algorithm under anesthesia. This will allow us to determine the relationships among measured amplitude-titrated seizure threshold (ST), measured MT, and simulated MT derived from electric field modeling. Our hypothesis is that both measured and simulated MT are correlated with STa, thus providing a clinically useful predictor of current amplitude necessary to perform seizure therapy under the time-constraints of anesthesia.
The study will consist of 10 individuals between 22 and 70 years old, with a major depressive disorder.
This is a within-subject safety and feasibility study that comprises three phases. Phase I includes medication taper (as clinically indicated), and baseline assessments.
In Phase II, patients will receive the 7 ultrabrief pulse width (0.3 ms) seizure therapy conditions. As treatments will be delivered on a 3 per week schedule.
On each experimental condition day, patients will undergo a number of procedures to assess clinical status and safety. Post procedure acute battery assessments will include: a) side effect questionnaire, b) neurocognitive battery, and c) neuroplasticity battery.
In Phase III, patients will be offered routine clinical management consisting of a conventional ECT course (typically 6 12 treatments) based on clinical need. Patients will receive pre- and post- course measures including: clinical rating scales, neurocognitive testing, neuroimaging, and a neuroplasticity battery.
Patients will also receive optional TMS EEG and ictal EEG recording at the 2nd, 8th or final 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 MT, and simulated MT derived from realistic head modeling.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)|
|Estimated Study Start Date :||May 22, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
This is a first-in-human study of safety and feasibility of a new approach to electroconvulsive therapy (ECT): individualized low amplitude seizure therapy. It uses high definition multielectrode array, coupled current amplitude titration to control the focal of seizure induction and individualize dosing. We aim to have 10 completers, between 21 and 70 years of age, with a current major depressive disorder in the context of unipolar major depression disorder eligible for ECT. The within-subject experiment comprises three phases. Phase I includes informed consent, screening, medication taper, and baseline clinical and neuroimaging assessments. Phase II, each patient will receive 7 experimental ECT configurations using the multielectrode array targeted to different brain regions. Finally, patients will be offered routine clinical ECT in Phase III.
Device: Multichannel Stimulation Interface
Multichannel Stimulation Interface
Each patient will receive 7 experimental ECT configurations using the multielectrode array targeted to different brain regions.
Device: Multichannel Stimulation Interface
Multichannel Stimulation Interface
No Intervention: 3
Patients will be offered routine clinical ECT in Phase III.
- 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: 2 years ]
- 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: 2 years ]
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
|Contact: Zhi-De Deng, Ph.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Sarah H Lisanby, M.D.||National Institute of Mental Health (NIMH)|