Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

October 6, 2016 updated by: Emad Sidhom, Behman Hospital
This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility (by successfully inducing therapeutic seizures during LAP-ST course)
Time Frame: 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
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)
Time Frame: From Baseline to end of acute course (average 2 weeks)
Measured by: Mini Mental State Examination
From Baseline to end of acute course (average 2 weeks)
Time to reorientation
Time Frame: From Baseline to end of acute course (average 2 weeks)
Measured by: Time to Orientation Test
From Baseline to end of acute course (average 2 weeks)
Efficacy
Time Frame: From Baseline to end of acute course (average 2 weeks)
Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders
From Baseline to end of acute course (average 2 weeks)
Efficacy
Time Frame: From Baseline to end of acute course (average 2 weeks)
Brief Psychiatric Rating Scale (BPRS) for psychotic disorders
From Baseline to end of acute course (average 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Behman Hospital

Investigators

  • Principal Investigator: Nagy A. Youssef, Medical College of Georgia, Augusta University
  • Principal Investigator: Emad Sidhom, Behman Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

October 5, 2016

First Submitted That Met QC Criteria

October 6, 2016

First Posted (Estimate)

October 10, 2016

Study Record Updates

Last Update Posted (Estimate)

October 10, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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