Suicidal Ideation / Sigma-Stim / RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral) · Phase 2/3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a recruiting, unfinished trial comparing Low-Amplitude Pulse Seizure Therapy (RUL LAP-ST) to standard Right Unilateral ECT in patients with suicidal ideation. No results are reported in this registry record. The study is designed to assess both anti-suicidal efficacy and cognitive side-effect burden over approximately four weeks.
Phase 2/3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Suicidal Ideation, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder; age from 18 Years; to 90 Years. Intervention: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Uni…. Compared with: RUL ECT (Electroconvulsive Therapy) — Active Comparator. n = 30. 1 site: United States.
This is a recruiting, unfinished trial comparing Low-Amplitude Pulse Seizure Therapy (RUL LAP-ST) to standard Right Unilateral ECT in patients with suicidal ideation. No results are reported in this registry record. The study is designed to assess both anti-suicidal efficacy and cognitive side-effect burden over approximately four weeks.
This registry record contains no results data; efficacy, safety, and cognitive outcomes are not reported.
The source did not state who this applies to in practice.
This is a recruiting Phase 2/3 trial with no posted results; the registry record describes planned enrollment and primary outcomes only, not efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06529029). This is a study registration, not published results. Lead sponsor: Michigan State University. Recruitment status: RECRUITING. Phase: PHASE2, PHASE3. Study type: INTERVENTIONAL. Enrollment: 30 participants (ESTIMATED). Conditions: Suicidal Ideation, Major Depressive Disorder, Schizo Affective Disorder, Bipolar Disorder. Interventions: DEVICE: Sigma-Stim; PROCEDURE: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral). Primary outcome measures: Suicide Ideation - Self Report , Through study completion, an average of four weeks; Suicide Ideation - Clinician Rated , Through study completion, an average of four weeks. Brief 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.
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