Optimizing Stimulation Parameters for Electroconvulsive Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patients being treated with electroconvulsive therapy at Pennsylvania Hospital who are willing and able to participate are eligible to be subjects in this study.
Disqualifiers
They are unwilling or unable to consent first to the SWEET COMBO protocol for optical monitoring during ECT
Clinically significant psychiatric comorbidity as determined by clinical interview and in the opinion of the Investigator and clinical team would alter the risk/benefit of the study
History of poor response to ECT treatment in the opinion of the Investigator and clinical team that would alter the risk/benefit of the study
subject's ability to participate safely in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Electroconvulsive Therapy
Procedure/SurgeryElectrical stimulation under anesthesia
Treatment groups
64 Participants
are divided into 4 treatment groupsGroup A: Index: Standard titration tableActive comparator 1 intervention
Group B: Index: Frequency-then-durationExperimental treatment 1 intervention
Group C: Index: Duration then FrequencyExperimental treatment 1 intervention
Group D: MaintenanceOther 1 intervention
Trial outcomes
Primary outcomes
1
Brain hemodynamics
Functional near infrared spectroscopy imaging will be performed during each ECT treatment, from which we will extract oxy- and deoxyhemoglobin concentrations (in mM) over time.
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.2
Electroencephalography - Seizure Duration
Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
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.3
Electroencephalography - theta band power
Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
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.4
Electroencephalography - Brain Symmetry Index
Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
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.Secondary outcomes
1
Quick Inventory of Depression Self-Report
Depression symptom scale filled out by patient. Unitless, ranging from 0-27.
Time frame
Administered pre-procedurally at baseline and once weekly for index arm patients (for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.2
Bush Francis Catatonia Rating Scale
Catatonia rating scale conducted by clinical team. Unitless, ranging from 0-69.
Time frame
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.3
Single Letter Fluency
Test of verbal fluency. Unit is number of words starting with a given letter provided in a one minute period.
Time frame
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.4
3 word registration and recall
Test of short term memory. Unit is number (out of 3) words registered and repeated back at 0 minutes, and the same at 3 minutes delay.
Time frame
Administered pre-procedurally at baseline and prior to every ECT treatment for index arm patients (12 treatments, 3 times weekly for for 4-6 weeks), or once monthly (for 8 months) in maintenance arm patients.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: