Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Study Overview
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Brief Summary
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This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).

Detailed Description
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This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.

Official Title
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Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Conditions
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Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders

Intervention / Treatment
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* Device: Mecta spectrum 5000Q device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ECT clinically indicated Males or females over 22 to 80 years of age Use of effective method of birth control for women of child-bearing capacity Patient is medically stable Capacity of patient to fully participate in the informed consent process as evaluated by their clinician Exclusion Criteria: Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT History of conditions that may make ECT unsafe such as metal in the head, or a skull defect Female patients who are currently pregnant or plan to be pregnant during the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Pulse Amplitude Seizure Therapy<br>Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device. | Device: Mecta spectrum 5000Q device<br>* LAP-ST and Right Unilateral (RUL) electrode placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (by successfully inducing therapeutic seizures during LAP-ST course) | Measured by: the elicitation of therapeutic seizure in the brain and assessed by using EEG | From first to last session of LAP-ST course (average approximately 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory (cognitive side effects) | Measured by: Mini Mental State Examination | From Baseline to end of acute course (average 2 weeks) | 
| Time to reorientation | Measured by: Time to Orientation Test | From Baseline to end of acute course (average 2 weeks) | 
| Efficacy | Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders | From Baseline to end of acute course (average 2 weeks) | 
| Efficacy | Brief Psychiatric Rating Scale (BPRS) for psychotic disorders | From Baseline to end of acute course (average 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Pulse Amplitude Seizure Therapy, Electroconvulsive Therapy, Low Pulse Amplitude Electroconvulsive Therapy, Low Pulse Amplitude ECT, LAP, LAP-ST, ECT, Mood disorders, Psychotic disorders