Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Behman Hospital22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Mecta spectrum 5000Q deviceDEVICE

LAP-ST and Right Unilateral (RUL) electrode placement.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ECT clinically indicated 2. Males or females over 22 to 80 years of age 3. Use of effective method of birth control for women of child-bearing capacity 4. Patient is medically stable 5. Capacity of patient to fully participate in the informed consent process as evaluated by their clinician Exclusion Criteria: 1. Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT 2. History of conditions that may make ECT unsafe such as metal in the head, or a skull defect 3. Female patients who are currently pregnant or plan to be pregnant during the study

Outcomes

Primary Outcomes

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

Time frame: From first to last session of LAP-ST course (average approximately 2 weeks)

Secondary Outcomes

Memory (cognitive side effects)

Measured by: Mini Mental State Examination

Time frame: From Baseline to end of acute course (average 2 weeks)

Time to reorientation

Measured by: Time to Orientation Test

Time frame: From Baseline to end of acute course (average 2 weeks)

Efficacy

Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders

Time frame: From Baseline to end of acute course (average 2 weeks)

Efficacy

Brief Psychiatric Rating Scale (BPRS) for psychotic disorders

Time frame: From Baseline to end of acute course (average 2 weeks)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.