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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pulse Amplitude ECT (LAP) | Experimental | Right Unilateral LAP ECT |
|
| standard Right Unilateral ECT | Active Comparator | standard Right Unilateral ECT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spectrum 5000Q ECT device (RUL ECT) | Device |
| ||
| spectrum 5000Q ECT device (RUL LAP ECT) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagy Youssef, MD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Colleage of Georgia, Augusta University | Evans | Georgia | 30809 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31035665 | Result | Youssef NA, Ravilla D, Patel C, Yassa M, Sadek R, Zhang LF, McCloud L, McCall WV, Rosenquist PB. Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial. Brain Sci. 2019 Apr 29;9(5):99. doi: 10.3390/brainsci9050099. | |
| 33215889 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 14, 2024 | |
| Reset | Apr 10, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2024 | Apr 10, 2024 |
| ID | Term |
|---|---|
| D003863 | Depression |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| Device |
|
| 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) |
| Derived |
| Youssef NA, Dhanani S, Rosenquist PB, McCloud L, McCall WV. Treating Posttraumatic Stress Disorder Symptoms With Low Amplitude Seizure Therapy (LAP-ST) Compared With Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial. J ECT. 2020 Dec;36(4):291-295. doi: 10.1097/YCT.0000000000000701. |