Recruiting
Phase 2
Phase 3

Low Amplitude Pulse Seizure Therapy vs. Standard Ultra-Brief ECT

Sponsor:

Michigan State University

Code:

NCT06529029

Conditions

Suicidal Ideation

Major Depressive Disorder

Schizo Affective Disorder

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sigma-Stim

RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)

Study Details

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.

Conditions

Suicidal Ideation

Major Depressive Disorder

Schizo Affective Disorder

Bipolar Disorder

Study ID

NCT06529029

Start date

Jul 3, 2024

Status verified date

Aug, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients in whom ECT is clinically indicated: The referrals to ECT by the primary psychiatrist (before a consult by the ECT consultant) will serve to both increase the feasibility of the study and address any ethical concerns that the patient would not undergo ECT without having a valid full indication for the procedure as well as increase the external validity and generalizability of the study.
2. Male or female patients 18 to 90 years of age
3. Current DSM-5 criteria for MDE with any SI of major depressive, bipolar, or schizoaffective disorders
4. Montgomery-Asberg depression rating scale (MADRS) with 2 or more on SI item
5. Use of effective method of birth control for women of child-bearing capacity
6. Patient is medically stable
7. No anticipated need to alter psychotropic medications for the duration of the study (except for urgent/emergent situations)
8. Ability of patient to fully participate in the informed consent process

Exclusion Criteria:

1. Unstable or serious medical condition that substantially increases risks of ECT or cognitive impairment
2. Female patients who are pregnant or plan to be pregnant during the study or are breast-feeding
3. History of neurological disorder if deemed by the treating ECT physician or PI to pose a significant risk with ECT, or if there is any metal in the head or history of known structural brain lesion or skull defect that is deemed to affect cognition or safe ECT treatment
4. Implanted devices that make ECT unsafe
5. Clinical presentation of delirium or dementia
6. Active substance use disorders within 1 week of randomization
7. ECT in the past 1 month or prior failure to respond to an adequate course of ECT as deemed by the ECT physician treating the patient or the PI

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)

Low Amplitude Pulse Seizure Therapy RUL ECT at 600mA (or 700mA)

active comparator: RUL ECT (Electroconvulsive Therapy)

RUL Conventional pulse amplitude Electroconvulsive Therapy (ECT)

Interventions

Sigma-Stim

Right Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA.

RUL LAP-ST (Low-Amplitude Pulse Seizure Therapy - Right Unilateral)

Please see description above

Primary outcome measure

  • Suicide Ideation - Self Report [ Time Frame: Through study completion, an average of four weeks ]
  • Suicide Ideation - Clinician Rated [ Time Frame: Through study completion, an average of four weeks ]

Central Contacts and Locations

Central contacts

Locations

Pine Rest Christian Mental Health Services

Recruiting

Grand Rapids, Michigan, United States, 49548

Contacts

Principal Investigator:

Nagy A Youssef, MD, PhD

More Information

Sponsor

Michigan State University

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • Suicidal Ideation
  • Suicide
  • Depression
  • Major Depressive Disorder
  • Schizo Affective Disorder
  • Bipolar Disorder
  • Low Amplitude Seizure Therapy
  • Electroconvulsive Therapy
  • Neuromodulation
  • Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michigan State University on 2026-08-12.