Low Pulse Amplitude Focal ECT (LAP Study)

Phase 3

Completed

• Conditions: Depression
• Interventions: Device: spectrum 5000Q ECT device (RUL LAP ECT); Device: spectrum 5000Q ECT device (RUL ECT)

• Registration Number: NCT02583490
• Lead Sponsor: Augusta University

Brief Summary

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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-20
• Study First Posted: 2015-10-22
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-18
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Pulse Amplitude ECT (LAP)	spectrum 5000Q ECT device (RUL LAP ECT)	Right Unilateral LAP ECT
standard Right Unilateral ECT	spectrum 5000Q ECT device (RUL ECT)	standard Right Unilateral ECT

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Resilience	From Baseline to end of acute course (typically after 4 weeks)	Connor-Davidson Resilience Scale
Suicidal Ideation	From Baseline to end of acute course (typically after 4 weeks)
Depression	From Baseline to end of acute course (typically after 4 weeks)	Patient Health Questionnaire (PHQ 9)
Trauma symptoms	From Baseline to end of acute course (typically after 4 weeks)	PTSD Checklist

Trial Locations

Locations (1)

Medical Colleage of Georgia, Augusta University; 🇺🇸 Evans, Georgia, United States