Low Pulse Amplitude Focal ECT (LAP Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Low Pulse Amplitude Focal Electroconvulsive Therapy

Conditions
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Depression

Intervention / Treatment
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* Device: spectrum 5000Q ECT device (RUL ECT)
* Device: spectrum 5000Q ECT device (RUL LAP ECT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory (cognitive side effects) | 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 | 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 | Connor-Davidson Resilience Scale | From Baseline to end of acute course (typically after 4 weeks) | 
| Suicidal Ideation |  | From Baseline to end of acute course (typically after 4 weeks) | 
| Depression | 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 | Patient Health Questionnaire (PHQ 9) | From Baseline to end of acute course (typically after 4 weeks) | 
| Trauma symptoms | PTSD Checklist | From Baseline to end of acute course (typically after 4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT, Electroconvulsive Therapy, Low Pulse Amplitude Focal Electroconvulsive Therapy, Depression, Suicidal Ideation