Depression - Major Depressive DisorderPRESTONCT07561307
Optimizing Stimulation Parameters for Electroconvulsive Therapy
A study testing Electroconvulsive Therapy in people with Depression - Major Depressive Disorder and Catatonia, run by University of Pennsylvania at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression - Major Depressive Disorder, Catatonia
- What is being tested?
- Electroconvulsive Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise, interfere with, limit, affect or reduce the:
- subject's ability to participate safely in the study
- integrity of the data or
- subject's ability to complete the full duration of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mario Cristancho, MD contact
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19146
Zachary Rosenthal, 9738976511, Zachary.Rosenthal@pennmedicine.upenn.edu
About this study
Official title: Parameter Refinement for ECT Stimulation and Titration Optimization
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:
Read more
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.
Read the detailed description
This is an exploratory, single-center open-label clinical trial at Pennsylvania Hospital (PAH) intended to optimize stimulation settings for electroconvulsive therapy (ECT), guided by real-time monitoring of both seizure and a recently discovered postictal event: cortical spreading depolarization (CSD). We will address three key questions: 1. What is the best strategy for up-titrating settings for ECT?; 2. How do individual pulse parameters impact brain evoked response?; 3. Are there stimulation settings that directly induce CSD waves without seizure?
This study will take place in the context of routine treatments for patients already consenting to receive ECT for a wide range of clinical indications. Patients will be enrolled in one of two arms:
- Index Titration Arm: Patients coming in for initial index ECT courses (acute phase) will be randomized to one of several stimulation parameter titration tables while receiving otherwise routine ECT care.
- Maintenance Arm: In clinically stable patients receiving monthly maintenance ECT, a sub-convulsive stimulation settings ramp will be performed under anesthesia immediately preceding their regular ECT treatment.
All patients being treated with ECT at PAH are eligible for this study. Outcomes will include non-invasive monitoring of brain hemodynamics and EEG as well as clinical symptom scales.
- Conditions
- Depression - Major Depressive Disorder, Catatonia
- Being tested
- Electroconvulsive Therapy
- Keywords
- electroconvulsive therapy
- Medical subject headings
- Catatonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive TherapyProcedure or surgery
Electrical stimulation under anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Index: Standard titration table | Active comparator | Patients are treated with ECT using titration table 1 (alternating increases in frequency and duration) Receives: Procedure: Electroconvulsive Therapy |
| Index: Frequency-then-duration | Experimental | ECT provided using Table 2, frequency uptitration followed by duration uptitration Receives: Procedure: Electroconvulsive Therapy |
| Index: Duration then Frequency | Experimental | ECT provided using Table 3, duration titration then frequency titration Receives: Procedure: Electroconvulsive Therapy |
| Maintenance | Other | Internal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols Receives: Procedure: Electroconvulsive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Electroencephalography - Seizure Duration
Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
Measured: 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.
Electroencephalography - theta band power
Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
Measured: 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.
Electroencephalography - Brain Symmetry Index
Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
Measured: 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 (6)
Quick Inventory of Depression Self-Report
Depression symptom scale filled out by patient. Unitless, ranging from 0-27.
Measured: 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.
Bush Francis Catatonia Rating Scale
Catatonia rating scale conducted by clinical team. Unitless, ranging from 0-69.
Measured: 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.
Single Letter Fluency
Test of verbal fluency. Unit is number of words starting with a given letter provided in a one minute period.
Measured: 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 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.
Measured: 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.
Psychotic Depression Assessment Scale (PDAS)
Psychosis rating scale for patients with psychosis, to be administered by clinical team. Unitless, ranging from 0-44.
Measured: 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
Clinical Global Impressions Scale for Severity and Improvement
To be determined by clinical team. Unitless, ranging from 0-7.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients are treated with ECT using different stimulation parameters
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zach Rosenthal, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561307
- Sponsor's protocol ID
- 26-6396
- Acronym
- PRESTO
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parameter Refinement for ECT Stimulation and Titration Optimization
- ClinicalTrials.gov ID
- NCT07561307
- Acronym / sponsor ID
- PRESTO / 26-6396
- Conditions
- Depression - Major Depressive Disorder, Catatonia
- Keywords
- electroconvulsive therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an exploratory, single-center open-label clinical trial at Pennsylvania Hospital (PAH) intended to optimize stimulation settings for electroconvulsive therapy (ECT), guided by real-time monitoring of both seizure and a recently discovered postictal event: cortical spreading depolarization (CSD). We will address three key questions: 1. What is the best strategy for up-titrating settings for ECT?; 2. How do individual pulse parameters impact brain evoked response?; 3. Are there stimulation settings that directly induce CSD waves without seizure?
This study will take place in the context of routine treatments for patients already consenting to receive ECT for a wide range of clinical indications. Patients will be enrolled in one of two arms:
- Index Titration Arm: Patients coming in for initial index ECT courses (acute phase) will be randomized to one of several stimulation parameter titration tables while receiving otherwise routine ECT care.
- Maintenance Arm: In clinically stable patients receiving monthly maintenance ECT, a sub-convulsive stimulation settings ramp will be performed under anesthesia immediately preceding their regular ECT treatment.
All patients being treated with ECT at PAH are eligible for this study. Outcomes will include non-invasive monitoring of brain hemodynamics and EEG as well as clinical symptom scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- All patients are treated with ECT using different stimulation parameters
| Arm | Type | Receives |
|---|---|---|
| Index: Standard titration table | Active comparator | Procedure: Electroconvulsive TherapyPatients are treated with ECT using titration table 1 (alternating increases in frequency and duration) |
| Index: Frequency-then-duration | Experimental | Procedure: Electroconvulsive TherapyECT provided using Table 2, frequency uptitration followed by duration uptitration |
| Index: Duration then Frequency | Experimental | Procedure: Electroconvulsive TherapyECT provided using Table 3, duration titration then frequency titration |
| Maintenance | Other | Procedure: Electroconvulsive TherapyInternal cross-over arm in which patients undergo 8 sessions using 8 randomized sub-convulsive stimulation protocols |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
- Presence of any disease, medical condition or physical condition that, in the opinion of the Investigator, may compromise, interfere with, limit, affect or reduce the:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroconvulsive TherapyElectrical stimulation under anesthesia | Procedure or surgery | Index: Duration then Frequency, Index: Frequency-then-duration, Index: Standard titration table, Maintenance |
Primary outcome
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.
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.
Electroencephalography - Seizure Duration
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.
Bilateral EEG over FP1 and FP2 zones, from which we will compute seizure duration (in seconds)
Electroencephalography - theta band power
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.
Bilateral EEG over FP1 and FP2 zones, from which we will compute theta band power (in dB)
Electroencephalography - Brain Symmetry Index
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.
Bilateral EEG over FP1 and FP2 zones, from which we will compute brain symmetry index (unitless)
6 secondary outcomes
Quick Inventory of Depression Self-Report
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.
Bush Francis Catatonia Rating Scale
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.
Single Letter Fluency
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 word registration and recall
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.
Psychotic Depression Assessment Scale (PDAS)
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
Clinical Global Impressions Scale for Severity and Improvement
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mario Cristancho, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroconvulsive Therapy in people with Depression - Major Depressive Disorder and Catatonia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zachary Rosenthal, MD PhD (19738976511, Zachary.Rosenthal@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.