Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
NCT Number: NCT06529029
Acronym: LAP-ST vs ECT
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2|PHASE3
Conditions: Suicidal Ideation|Major Depressive Disorder|Schizo Affective Disorder|Bipolar Disorder
Interventions: DEVICE: Sigma-Stim
Sponsor: Michigan State University
Collaborators: Pine Rest Christian Mental Health Services
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-03
Completion Date: 2026-11-01
Locations: Pine Rest Christian Mental Health Services, Grand Rapids, Michigan, 49548, United States

Summary:
This protocol proposes an initial randomized clinical trial that includes all patients with suicidal ideation (SI) at baseline, and with SI as the primary outcome measure to examine whether Right Unilateral Low-Amplitude Pulse - Seizure Therapy (RUL LAP-ST) treatment has more magnitude and rate of remission of SI as conventional pulse amplitude Right Unilateral Electroconvulsive Therapy (RUL ECT) (based on our prior secondary analysis). Our central hypothesis is that RUL LAP-ST has significantly less cognitive/memory side effects (no memory side effects were noted in our prior studies for 500mA and 600mA) and thus is more favorable in terms of side effects compared to RUL conventional pulse amplitude ECT, while maintaining better anti-suicidal effect.

Primary Outcome Measures: Suicide Ideation - Self Report, Beck Scale for Suicide Ideation (SSI-Worst and SSI-Current) - self reported. Minimum score of 0, maximum score of 42. Lower score indicates a better outcome., Through study completion, an average of four weeks|Suicide Ideation - Clinician Rated, Columbia Suicide Severity Rating Scale (C-SSRS) - clinician administered. Intensity of suicidal ideation: minimum score of 0, maximum score of 5. Lower score indicates a better outcome. Suicidal behavior not rated on a scale., Through study completion, an average of four weeks
Secondary Outcome Measures: Depression - Clinician Rated, Montgomery-Asberg Depression Rating Scale (MADRS) - clinician administered. Minimum score of 0, maximum score of 60. Lower score indicates better outcome., Through study completion, an average of four weeks|Depression - Self Report, Patient Health Questionnaire (PHQ9) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome., Through study completion, an average of four weeks|Depression - Self Report, Quick Inventory of Depressive Symptomatology (QIDS-SR) - self reported. Minimum score of 0, maximum score of 27. Lower score indicates better outcome., Through study completion, an average of four weeks
Other Outcome Measures: Anxiety, Generalized Anxiety Disorder (GAD7) - self reported. Minimum score 0, maximum score 21. Lower score indicates better outcome., Through study completion, an average of four weeks|Psychosis, Positive and Negative Syndrome Scale (PANSS) - clinician administered. Full scale minimum score of 31. Maximum score of 217. Lower score indicates better outcome., Through study completion, an average of four weeks|Global Clinical Assessment, Clinical Global Improvement (CGI) - clinician administered. Severity: minimum score of 0, maximum score of 7, lower score indicates better outcome. Improvement: minimum score of 0, maximum score of 7, lower score indicates better outcome., Through study completion, an average of four weeks|Time to Reorientation after ECT sessions, Time to Reorientation scale (TRO) - study staff administered. Minimum score 3 minutes, maximum score more than 20 minutes. Lower score indicates better outcome., Through study completion, an average of four weeks|Cognitive function and cognitive side effects, Hopkins Verbal Learning Test-Revised (HVLTR) - clinician administered. Minimum score of 0, maximum score of 12. Higher score indicates better outcome., At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks|Cognitive Executive functions, Delis Kaplan Executive Function Scale (DKEFS) - verbal fluency and color/word interference modules - clinician administered. Verbal fluency: minimum score of 1, maximum score of 60. Higher scores indicate better outcome for the total score. Color-word interference: minimum score of 1, maximum score of 19. In general, higher score indicate better outcome., At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks|Autobiographic Memory side effects, Autobiographic Memory Interview-Short Form (AMI-SF) - clinician administered. Minimum score of 0, maximum score of 30. Higher score indicates better outcome., At baseline and completion of the acute ECT/LAP-ST course, an average of four weeks