Low Pulse Amplitude Focal ECT (LAP Study)

June 18, 2019 updated by: Nagy Adel Youssef, Augusta University

Low Pulse Amplitude Focal Electroconvulsive Therapy

This protocol proposes a pilot randomized clinical trial to examine whether Low Pulse Amplitude Focal ECT (LAP) has a more favorable cognitive profile compared to conventional unilateral ECT and that it has similar effects as traditional ECT in reducing suicidality. The study will enroll 10 patients recruited from the Medical College of Georgia (at Georgia Regents University/Augusta University, GRU/AU) as the only site of the study. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lower amplitude ECT (LAP) has been shown to induce seizures of adequate duration in a single titration session. This current study is hypothesized to increase stimulation focality, thus hypothetically minimizing cognitive side effects.

The central hypothesis is that LAP has significantly less cognitive adverse effects compared to conventional Right Unilateral (RUL) ECT.

The study will enroll 10 patients recruited from Medical College of Georgia. Patients referred to ECT service in the Medical College of Georgia usually occurs from clinical services and private physicians and the study will recruit patients who are clinically indicated to do ECT. Eligible participants will be randomly assigned (1:1 ratio) to receive a course of either RUL LAP ECT, or conventional RUL ECT.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Evans, Georgia, United States, 30809
        • Medical Colleage of Georgia, Augusta University

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in whom ECT therapy is clinically indicated
  • Males or females patients over 20 years of age
  • Current DSM-IV criteria for major depressive episode
  • Montgomery-Asberg depression rating scale (MADRS) greater than or equal to 20
  • Use of effective method of birth control for women of child-bearing capacity
  • Patient is medically stable
  • No anticipated need to alter psychotropic medications for the duration of the study
  • Ability of patient to fully participate in the informed consent process

Exclusion Criteria:

  • Unstable or serious medical condition that substantially increases risks of ECT or of cognitive impairment
  • Substance use disorders within 1 week of randomization
  • History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion that is deemed to affect cognition or safe ECT treatment
  • Vagal Nerve Stimulator implanted
  • Female patients who are pregnant or plan to be pregnant during the study breast-feeding
  • Implanted devices that make ECT unsafe, or a skull defect
  • Significant cognitive impairment (Mini-Mental State Examination (MMSE) less than 24)
  • ECT in the past 1 months
  • Benzodiazepine use will be limited to no more than 3 mg per day of lorazepam or its equivalents. Antidepressants and antipsychotics will be held constant during the ECT course of 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Pulse Amplitude ECT (LAP)
Right Unilateral LAP ECT
Device: spectrum 5000Q ECT device (RUL LAP ECT)
Active Comparator: standard Right Unilateral ECT
Device: spectrum 5000Q ECT device (RUL ECT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memory (cognitive side effects)
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
Measured by Autobiographic Memory Interview-Short form (AMI-SF, primary outcome)
From Baseline to end of acute course (typically after 4 weeks)
Time to reorientation
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
Measured by Time to Orientation Test (TRO, primary outcome)
From Baseline to end of acute course (typically after 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resilience
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
Connor-Davidson Resilience Scale
From Baseline to end of acute course (typically after 4 weeks)
Suicidal Ideation
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
From Baseline to end of acute course (typically after 4 weeks)
Depression
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
used to determine remission status; measured by Montgomery-Åsberg Depression Rating Scale (MADRS)
From Baseline to end of acute course (typically after 4 weeks)
Depression
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
Patient Health Questionnaire (PHQ 9)
From Baseline to end of acute course (typically after 4 weeks)
Trauma symptoms
Time Frame: From Baseline to end of acute course (typically after 4 weeks)
PTSD Checklist
From Baseline to end of acute course (typically after 4 weeks)

Collaborators and Investigators

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

Sponsor

Augusta University

Investigators

  • Principal Investigator: Nagy Youssef, MD, Augusta University

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 (Actual)

March 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 18, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low Pulse Amplitude Focal ECT

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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