Optimizing Stimulation Parameters for Electroconvulsive Therapy

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07561307
Status
Not Yet Recruiting

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Conditions

  • Catatonia
  • Depression - Major Depressive Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Electroconvulsive Therapy — PROCEDURE
    Electrical stimulation under anesthesia

Study Details

The goal of this clinical trial is to improve how electroconvulsive therapy (ECT) stimulation settings are chosen. Researchers will use real-time brain monitoring to measure both seizures and a recently identified brain event called cortical spreading depolarization (CSD). The main questions it aims to answer are: What is the best way to increase ECT stimulation settings? How do different pulse settings affect the brain's response? Can certain settings produce CSD without causing a seizure? Participants already receiving ECT as part of their care will take part. They will be assigned to one of two groups: Index ECT group: Participants starting ECT will receive different standard titration approaches. Maintenance ECT group: Participants receiving ongoing ECT will undergo a brief, low-dose stimulation test before treatment. All participants will be monitored using brain physiology (EEG and blood flow) and symptom scales during treatment.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

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

Arms

  • Active Comparator: Index: Standard titration table
    Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration)
  • Experimental: Index: Frequency-then-duration
    ECT provided using Table 2, frequency uptitration followed by duration uptitration
  • Experimental: Index: Duration then Frequency
    ECT provided using Table 3, duration titration then frequency titration
  • Other: Maintenance
    Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols

Primary Outcome Measure

Brain hemodynamics [ Time Frame: Periprocedural (10-20 minutes per ECT session). Assessed repeatedly over approximately 12 ECT sessions for index arm patients (3 times/week for 4-6 weeks), or for 8 sessions (once a month for 8 months) in the maintenance arm. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Pennsylvania HospitalPhiladelphiaPennsylvania19146
Zachary Rosenthal
[email protected]
9738976511

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By research site
Pennsylvania Hospital· Philadelphia, PA

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