Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-06-30

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).

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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.

Conditions

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Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Low Pulse Amplitude Seizure Therapy

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

Group Type EXPERIMENTAL

Mecta spectrum 5000Q device

Intervention Type DEVICE

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

Interventions

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Mecta spectrum 5000Q device

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No