Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Phase 1

Completed

• Conditions: Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Interventions: Device: Mecta spectrum 5000Q device

• Registration Number: NCT02928159
• Lead Sponsor: Behman Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-06
• Last Update Submitted: 2016-10-06
• Study First Posted: 2016-10-10
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Pulse Amplitude Seizure Therapy	Mecta spectrum 5000Q device	Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Memory (cognitive side effects)	From Baseline to end of acute course (average 2 weeks)	Measured by: Mini Mental State Examination
Time to reorientation	From Baseline to end of acute course (average 2 weeks)	Measured by: Time to Orientation Test
Efficacy	From Baseline to end of acute course (average 2 weeks)	Brief Psychiatric Rating Scale (BPRS) for psychotic disorders