Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Michigan State University
Study ID
NCT06529029
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Sigma-Stim — DEVICE
    Right Ultra-Brief Low Amplitude Seizure Therapy at 600mA or 700mA vs Right Unilateral Ultra-Brief Standard ECT at 800mA.

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
Sep 2025
Primary completion
Jul 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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)

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pine Rest Christian Mental Health ServicesGrand RapidsMichigan49548
Nagy A Youssef, MD, PhD
[email protected]
616-980-7516
Janelle M Kassien, LMSW
[email protected]
616-980-7516
Nagy A Youssef, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Grand Rapids, MI

By condition
Bipolar disorderDepression
By specialty
PsychiatryMental healthBehavioral health
By research site
Pine Rest Christian Mental Health Services· Grand Rapids, MI

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