Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Behman Hospital

Status and phase: Completed; Phase 1

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Mood Disorders

Treatments: Device: Mecta spectrum 5000Q device

Study type: Interventional

Funder types: Other

Identifiers

NCT02928159

001

Details and patient eligibility

About

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

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

22 participants in 1 patient group

Low Pulse Amplitude Seizure Therapy

Experimental group

Description:

Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device.

Treatment:

Device: Mecta spectrum 5000Q device