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This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pulse Amplitude Seizure Therapy | Experimental | Course of Right Unilateral Ultrabrief LAP-ST using Mecta spectrum 5000Q Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecta spectrum 5000Q device | Device | LAP-ST and Right Unilateral (RUL) electrode placement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (by successfully inducing therapeutic seizures during LAP-ST course) | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Memory (cognitive side effects) | Measured by: Mini Mental State Examination | From Baseline to end of acute course (average 2 weeks) |
| Time to reorientation | Measured by: Time to Orientation Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagy A. Youssef | Medical College of Georgia, Augusta University | Principal Investigator |
| Emad Sidhom | Behman Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28667887 | Derived | Youssef NA, Sidhom E. Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man. J Affect Disord. 2017 Nov;222:1-6. doi: 10.1016/j.jad.2017.06.022. Epub 2017 Jun 16. |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| From Baseline to end of acute course (average 2 weeks) |
| Efficacy | Montgomery-Åsberg Depression Rating Scale (MADRS) for depressive episodes of mood disorders | From Baseline to end of acute course (average 2 weeks) |
| Efficacy | Brief Psychiatric Rating Scale (BPRS) for psychotic disorders | From Baseline to end of acute course (average 2 weeks) |