Major Depressive Episode (MDE)FEAST-AFTNCT07857122
Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial
A study testing Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL) and Stimulation by Sigmastim ECT 200J device administered in bilateral (BT) in people with Major Depressive Episode (MDE) and Unipolar Disorder, run by Centre Hospitalier St Anne at 5 sites in 2 countries.
Trial summary
A significant proportion of patients remain resistant to antidepressant therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant psychiatric pathologies. ECT is also the gold standard for treating mood disorders. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Depressive Episode (MDE), Unipolar Disorder, Bipolar 1 Disorder
- What is being tested?
- Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL) and Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Nov 2026to 2 Jul 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years;
- Moderate-severe MDE as part of a unipolar or bipolar disorder (including psychotic and catatonic features) according to DSM-5-TR criteria (APA, 2022);
- Score ≥ 17 at the HDRS-17 at the inclusion interview (HAMILTON, 1960);
- Ability to understand the clinical investigation plan and comply with study visits;
- ECT indicated by the referring physician for MDE;
- Ability to tolerate the necessary adaptations to certain treatments (discontinuation, dosage, frequency of intake) for the proper conduct of ECT/FEAST (lithium, anticonvulsants with the exception of lamotrigine) and the restriction of benzodiazepine dosage to ≤ 3 mg/day of lorazepam equivalent (Boylan et al., 2000, Nahas et al., 2013, Sahlem et al., 2020, Youssef et al., 2021);
- Written informed consent.
Who cannot join
- Previous diagnosis of neurologic disease: neurodegenerative disease, epilepsy, encephalopathy, delirium tremens or memory disorder, …;
- Score < 23 on the MoCA at inclusion interview (Nasreddine et al., 2005);
- Other neurological diseases affecting the central nervous system or head trauma in progress or having had a cognitive impact according to the anamnesis and the clinician's assessment. This include: space-occupying cerebral lesions, such as tumors or hematomas, cerebrovascular aneurysms or malformations, recent stroke (hemorrhagic or ischemic), other causes of increased intracranial pressure (e.g., hydrocephalus, meningitis, encephalitis), skull defects (which may include metal devices in or near the site of stimulation), metal devices, such as screws and plates or metal meshes, may preclude specific stimulation patterns but may not preclude treatment administration completely, implanted active stimulatory devices (e.g., Deep Brain Stimulation devices). Stimulation devices may pose a risk to the patient if the flow of current during treatment damages active components of the device (i.e. potential for catastrophic failure of the battery);
- General condition and/or comorbidities not allowing general anesthesia to be performed;
- Severe and unstable pulmonary conditions increasing the risks of problematic airway management and aspiration during and immediately after ECT according to the anesthesiologist's assessment such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia;
- Severe and unstable cardiovascular conditions substantially increasing risks according to the anesthesiologist's assessment, such as recent and/or severe myocardial infarction, unstable angina, uncompensated congestive heart failure, vascular aneurysm or stenosis, clinically significant arrhythmias, uncontrolled hypertension or hypotension;
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- Concomitant psychotic disorder (schizophrenia, schizoaffective disorder) according to DSM-5-TR or than MED with psychotic features (APA, 2022);
- Moderate to severe substance use disorder in the 3 months preceding the inclusion in the study (except caffeine and nicotine) (G. L. Sahlem et al., 2016, Youssef et al., 2021);
- Rapid-cycling bipolar disorder (Youssef et al., 2021);
- Having received an acute course of ECT in the 3 months preceding the inclusion in the study;
- Participation in another interventional research protocol other than magnetic resonance imaging (MRI) studies);
- Patient deprived of their liberty by judicial or administrative decision;
- Patient under legal protection;
- Pregnant and breastfeeding women;
- Patient not affiliated to a social security or other social protection scheme.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Cécile MICHEL, MSc contact
5 sites in 2 countries
France4 sites
CH Le Vinatier
Bron, 69678
Filipe GALVAO, MD, Filipe.GALVAO@ch-le-vinatier.fr
Filipe GALVAO, MD
CHU Nantes
Nantes, 44000
Anne Sauvaget, MD, PhD, anne.sauvaget@chu-nantes.fr
GHU Paris Psychiatrie & Neurosciences - Neuromodulation Institute
Paris, 75014
Philippe Domenech, MD, PhD, +33 1 45 65 89 76, philippe.domenech@ghu-paris.fr
Mickaël AMAGAT, MD, m.amagat@ghu-paris.fr
CH du Rouvray
Sotteville-lès-Rouen, 76300
Maud ROTHARMEL, MD, maud.rotharmel@ch-lerouvray.fr
Maud ROTHARMEL, MD
Monaco1 site
CH Princesse Grace de Monaco
Monaco, 98000
David SZEKELY, MD, david.szekely@chpg.mc
David SZEKELY, MD
About this study
A significant proportion of patients remain resistant to antidepressant therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant psychiatric pathologies. ECT is also the gold standard for treating mood disorders. Although effective, it is associated with cognitive side effects (memory impairment, post-ECT confusion, longer reorientation time), particularly with bitemporal (BT) montage and brief pulse stimulation. These effects may contribute to patient reluctance and limit adherence to this therapy. From a mechanistic point of view, ECT causes changes in cerebral blood flow (rCBF) and brain electrical activity, particularly in the prefrontal cortex, where the induction of "pseudo-epileptic seizures" appears to be related to therapeutic efficacy, while cognitive side effects appear to be associated with alterations in the temporal areas. The conventional stimulation method results in widespread diffusion of the current due to the properties of the skull, limiting control over the distribution of intracerebral charge densities. In this context, a new approach called "Focal Electrically Administered Seizure Therapy" (FEAST) has been developed to focus the electrical current and limit cognitive side effects. Unlike traditional ECT, FEAST uses unidirectional current and optimized electrode placement, aiming to induce seizures in a more localized manner in the right prefrontal cortex while reducing propagation to temporal regions.
The FEAST configuration is based on scientific literature (protocols, parameters, electrode positioning) and not on a "pre configured" mode validated by the medical device manufacturer.
Read more
Neuroimaging studies suggest that FEAST causes an increase in blood flow in the right prefrontal cortex at the onset of the seizure, followed by a postictal redistribution similar to that observed with ECT, confirming its targeted effect. Open-label clinical trials conducted to date show that FEAST significantly improves depressive symptoms with a more favorable cognitive profile compared to traditional ECT, notably by reducing the impact on autobiographical memory and decreasing the time needed to regain orientation acutely after treatment. Several comparative studies between FEAST and unilateral ultra-brief pulse ECT suggest an advantage in terms of cognitive tolerance, although the differences are not always statistically significant. A multicenter trial also showed comparable effects on reducing suicidal ideation, suggesting that FEAST could be an alternative to traditional ECT. Indeed, preliminary studies indicate that FEAST may offer similar benefits to ECT in terms of reducing depressive symptoms, but with fewer cognitive side effects, which could lead to a better quality of life.
Although these studies are promising, they remain few in number and have methodological limitations (open-label clinical trials, feasibility studies, lack of randomization with a comparator arm, small sample size, or assignment to the study arm based on patient preference). There are currently no other randomized clinical trials on FEAST underway or in preparation worldwide. Well-designed, multicenter clinical trials with sufficient patient numbers to achieve satisfactory statistical power are therefore needed to address the limitations of previous studies and explore the clinical benefits of FEAST.
The present study is therefore a randomized, multicenter, double-blind clinical trial designed to evaluate the superiority of FEAST in terms of safety and efficacy compared to traditional ECT modalities.
Read the detailed description
Depression is a severe and debilitating illness affecting millions of people worldwide. Severe characterized depressive episodes (CDE), particularly those with melancholic or psychotic features, represent a major therapeutic challenge in psychiatry (Belmaker \& Agam, 2008). Although traditional treatments such as antidepressants, mood stabilizers and psychotherapies are effective for some patients, the response to these therapies is often inadequate (Rush et al., 2006). A significant proportion of patients remain resistant to these therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant psychiatric pathologies. ECT is also the gold standard for treating mood disorders. Although effective, it is associated with cognitive side effects (memory impairment, post-ECT confusion, longer reorientation time), particularly with bitemporal (BT) montage and brief pulse stimulation (Semkovska et al., 2016) (Sackeim et al., 2008; Nahas et al., 2013; Youssef et al., 2021). These effects may contribute to patient reluctance and limit adherence to this therapy (Nahas et al., 2013; Youssef et al., 2021). From a mechanistic point of view, ECT causes changes in cerebral blood flow (rCBF) and brain electrical activity, particularly in the prefrontal cortex, where the induction of "pseudo-epileptic seizures" appears to be related to therapeutic efficacy, while cognitive side effects appear to be associated with alterations in the temporal areas. The conventional stimulation method results in widespread diffusion of the current due to the properties of the skull, limiting control over the distribution of intracerebral charge densities. In this context, a new approach called "Focal Electrically Administered Seizure Therapy" (FEAST) has been developed to focus the electrical current and limit cognitive side effects (Berman et al., 2005; Spellman et al., 2009; Peterchev et al., 2015). Unlike traditional ECT, FEAST uses unidirectional current and optimized electrode placement, aiming to induce seizures in a more localized manner in the right prefrontal cortex while reducing propagation to temporal regions.
The FEAST configuration is based on scientific literature (protocols, parameters, electrode positioning) and not on a "pre configured" mode validated by the medical device manufacturer.
Neuroimaging studies suggest that FEAST causes an increase in blood flow in the right prefrontal cortex at the onset of the seizure, followed by a postictal redistribution similar to that observed with ECT, confirming its targeted effect. Open-label clinical trials conducted to date show that FEAST significantly improves depressive symptoms with a more favorable cognitive profile compared to traditional ECT, notably by reducing the impact on autobiographical memory and decreasing the time needed to regain orientation acutely after treatment. Several comparative studies between FEAST and unilateral ultra-brief pulse ECT suggest an advantage in terms of cognitive tolerance, although the differences are not always statistically significant. A multicenter trial also showed comparable effects on reducing suicidal ideation, suggesting that FEAST could be an alternative to traditional ECT. Indeed, preliminary studies indicate that FEAST may offer similar benefits to ECT in terms of reducing depressive symptoms, but with fewer cognitive side effects, which could lead to a better quality of life.
Although these studies are promising, they remain few in number and have methodological limitations (open-label clinical trials, feasibility studies, lack of randomization with a comparator arm, small sample size, or assignment to the study arm based on patient preference). There are currently no other randomized clinical trials on FEAST underway or in preparation worldwide. Well-designed, multicenter clinical trials with sufficient patient numbers to achieve satisfactory statistical power are therefore needed to address the limitations of previous studies and explore the clinical benefits of FEAST.
The present study is therefore a randomized, multicenter, double-blind clinical trial designed to evaluate the superiority of FEAST in terms of safety and efficacy compared to traditional ECT modalities.
- Being tested
- Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL), Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)
- Keywords
- ECT, FEAST, randomized, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stimulation by the Sigma ECT/FEAST deviceDevice
Titration followed by a charge applied corresponding to 6 times the seizure threshold (6xST) during the second session (first suprathreshold session).
Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week.
Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions.
The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months.
Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL)Device
Titration followed by a charge applied corresponding to 6 times the seizure threshold (6xST) during the second session (first suprathreshold session).
Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week.
Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions.
The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months.
Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)Device
Titration followed by a charge applied corresponding to 6 times the seizure threshold (1.5xST) during the second session (first suprathreshold session).
Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week.
Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions.
The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months.
| Study group | Role | What they receive |
|---|---|---|
| FEAST | Experimental | FEAST stimulation administered with 2 electrodes with Ultrabrief Parameter Set (initial values of 0.30 ms) Receives: Device: Stimulation by the Sigma ECT/FEAST device |
| RUL ECT | Active comparator | ECT stimulation administered in right unilateral with Ultra Brief pulse (0.3 ms) Receives: Device: Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL) |
| BT ECT | Active comparator | ECT stimulation administered in bilateral with brief pulse (1 ms) Receives: Device: Stimulation by Sigmastim ECT 200J device administered in bilateral (BT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Q-LES-Q-SF score at Day 5
Change in Q-LES-Q-SF score from inclusion to Day 5 (5 days after the last session of the acute phase treatment (Post treatment visit (D5 ± 2 days)). The total raw score ranges from 14 to 70. . The higher the score, the better the person's quality of life and self-reported satisfaction.
Measured: From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)
Secondary outcomes (24)
Changes in Hamilton Rating Scale for Depression-17 items (HDRS-17) scores from inclusion to end of study (EOS)
HDRS-17 (HAMILTON, 1960, Bagby et al., 2004) completed at inclusion (V1), once a week during the acute randomized treatment period (W1 to W6), at the end of the acute randomized treatment period (D5), at M1 and M6 follow-up assessments. The total maximum score is 52, the minimum is 0. . The general clinical thresholds are: ≤7 after treatment = remission, 8-16 = mild, ≥17= moderate to severe.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Remission rate
Remission rate is defined as the number of patients with an HDRS-17 total score ≤ 7 divided by the total number of HDRS-17 evaluations from inclusion (V1) to End of study (EOS). The unit will be %.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of responders at Day 5
The number of responders is defined as patients with ≥50% reduction in HDRS-17 total score at Day 5 (5 days after the end of the acute treatment) compared to the score at inclusion.
Measured: From enrollment date until the 5th day after the end of the acute treatment (Day 5), assessed up to 2 months and 3 weeks
Number of responders at Month 1
The number of responders is defined as patients with ≥50% reduction in HDRS-17 total score at Month 1 (M1), 1 month post end of acute treatment, compared to the score at inclusion.
Measured: From enrollment date until the Month 1 after the end of the acute treatment (M1), assessed up to 3,5 months
Number of responders at Month 6 (End of Study)
The number of responders is defined as patients with ≥50% reduction in HDRS-17 total score at Month 6 (M6), 6 months post end of acute treatment, compared to the score at inclusion. The M6 visit is the End of Study visit (EOS).
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of partial responders throughout the study
The number of partial responders is defined as patients with >30% reduction in HDRS-17 total scores throughout the study, compared to the score at inclusion
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of patients with a reduced score on the suicidal ideation item of the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study compared to inclusion
The number of patients with a reduced score on the suicidal ideation item of the C-SSRS throughout the study, compared to the score at inclusion
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Clinical Global Impression-Severity (CGI-S) and CGI-improvement (CGI-I) scores
CGI-S and CGI-I (Guy and Cleary, 1976, Berk et al., 2008, Nahas et al., 2013) scores at inclusion (V1), once a week during the randomized acute treatment period, at the end of the randomized acute treatment period (D5), and at M1 and M6. Improved versions of these scales will be used (Kadouri et al., 2007). The scores at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Columbia-Suicide Severity Rating Scale (C-SSRS) total scores
C-SSRS (Greist et al., 2014) total scores at inclusion (V1), once a week during the acute treatment period, at M1 and End of study (EOS). The scores at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Quick Inventory of Depressive Symptomatology-Clinician rated (QIDS-C) total scores
QIDS-C total score completed at inclusion (V1), once a week during the acute randomized treatment period (W1 to W6), at the end of the acute randomized treatment period (D5), at M1 and End of Study (EOS) visit. The score at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
EQ-5D-5L total scores
EQ-5D-5L total score completed at inclusion (V1), D5, M1 and End of Study (EOS) visit. The scores at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Mean time to Orientation Recovery (TOR)
TOR is defined as the time required for a patient to remember 4 of the following 5 items: name, date of birth, age, place and day of the week. A stopwatch will be used to calculate the TOR. After the seizure, once participants open their eyes, each of the above guidance questions will be asked every 30 seconds until they are all answered correctly. The TOR will be assessed continuously for 90 min, and patients who fail to meet the TOR criteria will be given a score of 100 min. The TOR will be averaged for each patient and compared between the 3 study arms.
The unit is : minutes.
Measured: From the end of the first session to the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Number of adverse Events (AE) during the sessions of the acute treatment
AE during the session of the acute treatment: heart rhythm disorder, prolonged seizure; after the session: confusion, memory impairment (retrograde amnesia, anterograde memory), headache, nausea, myalgia and agitation, alterations of executive and attentional functions
Measured: From week 1 until week 6 (acute treatment), assessed up to 6 weeks
Patient VAS for memory disorders scores
VAS for memory disorders (patient) scores at inclusion (V1), each day before the 1st session and at the end of the day, D5, M1 and End of Study (EOS).
The minimum is 0 and the maximum is 100mm. Unit is millimeters.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Assessor VAS for memory disorders scores
VAS for memory disorders (assessor) scores at inclusion (V1), each day before the 1st session and at the end of the day, D5, M1 and M6.
The minimum is 0 and the maximum is 100mm. Unit is millimeters.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
ElectroConvulsive therapy Cognitive Assessment (ECCA) total score
ECCA (Hermida et al., 2020) total score completed at inclusion (V1), D5, M1 and Eond of Study (EOS). The scores at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Columbia Autobiographical Memory Interview-Short Form (AMI-SF) total scores
AMI-SF (McElhiney et al., 1995, Semkovska et al., 2012) total score completed at inclusion (V1), D5, M1 and End of Study (EOS). The score at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Montreal Cognitive Assessment (MoCA) total scores
MoCA (Nasreddine et al., 2005) total score completed at inclusion (V1), D5, M1 and End of Study (EOS). The score at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Verbal Fluency test total scores
Verbal Fluency test from the French Standard Executive Neuropsychological Test Battery (Bayard, et al., 2025) total score completed at inclusion (V1), D5, M1 and End of Study (EOS). The score at each timepoint will be compared to the score at inclusion.
Measured: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Rate of planned ECT/FEAST sessions realized (%)
Number of ECT/FEAST sessions realized compared to the total number of planned ECT/FEAST sessions (%). Causes of sessions not realized will be described.
Measured: From Week 1 (start of acute treatment) until the date of End of study visit(EOS), assessed up to From date of enrollment until the date of end of study visit (EOS), assessed up to 7,5 months
Mean EEG seizure duration
Mean of EEG seizure duration per session (in seconds).
Measured: From the end of the first session until the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Mean motor seizure duration
Mean of motor seizure duration per session (in seconds).
Measured: From the end of the first session until the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Number of Spontaneous Abnormal Brain Currents (SABc) per group
SABc will be recorded as present or absent. The number of SABc present in each group will be analyzed
Measured: From the end of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
Rate of efficient electric or clinic crisis (%)
Rate of efficient electric or clinic crisis according to Nobler criteria (Nobler et al., 1994) defined as the number of patients with efficient electric or clinic crisis divided by the total number of session delivered from start of acute treatment (W1) to End of study (EOS)
Measured: From the date of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Episode (MDE)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Prospective, multicenter, randomized (ratio 1:1:1), double-blind, parallel-group interventional superiority trial. Three treatment arms will be compared.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Neuromodulation Institute
- Responsible party
- Sponsor
- Investigators
- Harold SACKHEIM, MD, PhD, Study chair, Department of Psychiatry and Behavioral Sciences College of Medicine Medical University of South Carolina (MUSC) Charleston, South Carolina, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857122
- Sponsor's protocol ID
- D25-P040
- Acronym
- FEAST-AFT
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: GDPR in force in Europe and clinical trial :
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07857122
- Acronym / sponsor ID
- FEAST-AFT / D25-P040
- Keywords
- ECT, FEAST, randomized, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Neuromodulation Institute
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jul 2030 (estimated)
- First posted
- 5 Oct 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.
A significant proportion of patients remain resistant to antidepressant therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant psychiatric pathologies. ECT is also the gold standard for treating mood disorders. Although effective, it is associated with cognitive side effects (memory impairment, post-ECT confusion, longer reorientation time), particularly with bitemporal (BT) montage and brief pulse stimulation. These effects may contribute to patient reluctance and limit adherence to this therapy. From a mechanistic point of view, ECT causes changes in cerebral blood flow (rCBF) and brain electrical activity, particularly in the prefrontal cortex, where the induction of "pseudo-epileptic seizures" appears to be related to therapeutic efficacy, while cognitive side effects appear to be associated with alterations in the temporal areas. The conventional stimulation method results in widespread diffusion of the current due to the properties of the skull, limiting control over the distribution of intracerebral charge densities. In this context, a new approach called "Focal Electrically Administered Seizure Therapy" (FEAST) has been developed to focus the electrical current and limit cognitive side effects. Unlike traditional ECT, FEAST uses unidirectional current and optimized electrode placement, aiming to induce seizures in a more localized manner in the right prefrontal cortex while reducing propagation to temporal regions.
The FEAST configuration is based on scientific literature (protocols, parameters, electrode positioning) and not on a "pre configured" mode validated by the medical device manufacturer.
Neuroimaging studies suggest that FEAST causes an increase in blood flow in the right prefrontal cortex at the onset of the seizure, followed by a postictal redistribution similar to that observed with ECT, confirming its targeted effect. Open-label clinical trials conducted to date show that FEAST significantly improves depressive symptoms with a more favorable cognitive profile compared to traditional ECT, notably by reducing the impact on autobiographical memory and decreasing the time needed to regain orientation acutely after treatment. Several comparative studies between FEAST and unilateral ultra-brief pulse ECT suggest an advantage in terms of cognitive tolerance, although the differences are not always statistically significant. A multicenter trial also showed comparable effects on reducing suicidal ideation, suggesting that FEAST could be an alternative to traditional ECT. Indeed, preliminary studies indicate that FEAST may offer similar benefits to ECT in terms of reducing depressive symptoms, but with fewer cognitive side effects, which could lead to a better quality of life.
Although these studies are promising, they remain few in number and have methodological limitations (open-label clinical trials, feasibility studies, lack of randomization with a comparator arm, small sample size, or assignment to the study arm based on patient preference). There are currently no other randomized clinical trials on FEAST underway or in preparation worldwide. Well-designed, multicenter clinical trials with sufficient patient numbers to achieve satisfactory statistical power are therefore needed to address the limitations of previous studies and explore the clinical benefits of FEAST.
The present study is therefore a randomized, multicenter, double-blind clinical trial designed to evaluate the superiority of FEAST in terms of safety and efficacy compared to traditional ECT modalities.
Detailed description
Depression is a severe and debilitating illness affecting millions of people worldwide. Severe characterized depressive episodes (CDE), particularly those with melancholic or psychotic features, represent a major therapeutic challenge in psychiatry (Belmaker \& Agam, 2008). Although traditional treatments such as antidepressants, mood stabilizers and psychotherapies are effective for some patients, the response to these therapies is often inadequate (Rush et al., 2006). A significant proportion of patients remain resistant to these therapies, even when treatment is well managed. Electroconvulsive therapy (ECT) is a well-established method for treating certain severe and resistant psychiatric pathologies. ECT is also the gold standard for treating mood disorders. Although effective, it is associated with cognitive side effects (memory impairment, post-ECT confusion, longer reorientation time), particularly with bitemporal (BT) montage and brief pulse stimulation (Semkovska et al., 2016) (Sackeim et al., 2008; Nahas et al., 2013; Youssef et al., 2021). These effects may contribute to patient reluctance and limit adherence to this therapy (Nahas et al., 2013; Youssef et al., 2021). From a mechanistic point of view, ECT causes changes in cerebral blood flow (rCBF) and brain electrical activity, particularly in the prefrontal cortex, where the induction of "pseudo-epileptic seizures" appears to be related to therapeutic efficacy, while cognitive side effects appear to be associated with alterations in the temporal areas. The conventional stimulation method results in widespread diffusion of the current due to the properties of the skull, limiting control over the distribution of intracerebral charge densities. In this context, a new approach called "Focal Electrically Administered Seizure Therapy" (FEAST) has been developed to focus the electrical current and limit cognitive side effects (Berman et al., 2005; Spellman et al., 2009; Peterchev et al., 2015). Unlike traditional ECT, FEAST uses unidirectional current and optimized electrode placement, aiming to induce seizures in a more localized manner in the right prefrontal cortex while reducing propagation to temporal regions.
The FEAST configuration is based on scientific literature (protocols, parameters, electrode positioning) and not on a "pre configured" mode validated by the medical device manufacturer.
Neuroimaging studies suggest that FEAST causes an increase in blood flow in the right prefrontal cortex at the onset of the seizure, followed by a postictal redistribution similar to that observed with ECT, confirming its targeted effect. Open-label clinical trials conducted to date show that FEAST significantly improves depressive symptoms with a more favorable cognitive profile compared to traditional ECT, notably by reducing the impact on autobiographical memory and decreasing the time needed to regain orientation acutely after treatment. Several comparative studies between FEAST and unilateral ultra-brief pulse ECT suggest an advantage in terms of cognitive tolerance, although the differences are not always statistically significant. A multicenter trial also showed comparable effects on reducing suicidal ideation, suggesting that FEAST could be an alternative to traditional ECT. Indeed, preliminary studies indicate that FEAST may offer similar benefits to ECT in terms of reducing depressive symptoms, but with fewer cognitive side effects, which could lead to a better quality of life.
Although these studies are promising, they remain few in number and have methodological limitations (open-label clinical trials, feasibility studies, lack of randomization with a comparator arm, small sample size, or assignment to the study arm based on patient preference). There are currently no other randomized clinical trials on FEAST underway or in preparation worldwide. Well-designed, multicenter clinical trials with sufficient patient numbers to achieve satisfactory statistical power are therefore needed to address the limitations of previous studies and explore the clinical benefits of FEAST.
The present study is therefore a randomized, multicenter, double-blind clinical trial designed to evaluate the superiority of FEAST in terms of safety and efficacy compared to traditional ECT modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, multicenter, randomized (ratio 1:1:1), double-blind, parallel-group interventional superiority trial. Three treatment arms will be compared.
| Arm | Type | Receives |
|---|---|---|
| FEAST | Experimental | Device: Stimulation by the Sigma ECT/FEAST deviceFEAST stimulation administered with 2 electrodes with Ultrabrief Parameter Set (initial values of 0.30 ms) |
| RUL ECT | Active comparator | Device: Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL)ECT stimulation administered in right unilateral with Ultra Brief pulse (0.3 ms) |
| BT ECT | Active comparator | Device: Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)ECT stimulation administered in bilateral with brief pulse (1 ms) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 90 years;
- Moderate-severe MDE as part of a unipolar or bipolar disorder (including psychotic and catatonic features) according to DSM-5-TR criteria (APA, 2022);
- Score ≥ 17 at the HDRS-17 at the inclusion interview (HAMILTON, 1960);
- Ability to understand the clinical investigation plan and comply with study visits;
- ECT indicated by the referring physician for MDE;
Key exclusion criteria (15 listed)
- Previous diagnosis of neurologic disease: neurodegenerative disease, epilepsy, encephalopathy, delirium tremens or memory disorder, …;
- Score < 23 on the MoCA at inclusion interview (Nasreddine et al., 2005);
- Other neurological diseases affecting the central nervous system or head trauma in progress or having had a cognitive impact according to the anamnesis and the clinician's assessment. This include: space-occupying cerebral lesions, such as tumors or hematomas, cerebrovascular aneurysms or malformations, recent stroke (hemorrhagic or ischemic), other causes of increased intracranial pressure (e.g., hydrocephalus, meningitis, encephalitis), skull defects (which may include metal devices in or near the site of stimulation), metal devices, such as screws and plates or metal meshes, may preclude specific stimulation patterns but may not preclude treatment administration completely, implanted active stimulatory devices (e.g., Deep Brain Stimulation devices). Stimulation devices may pose a risk to the patient if the flow of current during treatment damages active components of the device (i.e. potential for catastrophic failure of the battery);
- General condition and/or comorbidities not allowing general anesthesia to be performed;
- Severe and unstable pulmonary conditions increasing the risks of problematic airway management and aspiration during and immediately after ECT according to the anesthesiologist's assessment such as chronic obstructive pulmonary disease (COPD), asthma, pneumonia;
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 |
|---|---|---|
| Stimulation by the Sigma ECT/FEAST deviceTitration followed by a charge applied corresponding to 6 times the seizure threshold (6xST) during the second session (first suprathreshold session). Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week. Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions. The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months. | Device | FEAST |
| Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL)Titration followed by a charge applied corresponding to 6 times the seizure threshold (6xST) during the second session (first suprathreshold session). Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week. Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions. The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months. | Device | RUL ECT |
| Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)Titration followed by a charge applied corresponding to 6 times the seizure threshold (1.5xST) during the second session (first suprathreshold session). Acute treatment (week 1 à 6): FEAST/ECT sessions will take place 3 times a week. Regardless of the intervention group, the research team will recommend that treatment sessions continue until clinical remission is documented, if possible, with a maximum of 18 sessions. The consolidation phase will be carried out according to the effective parameters applied during the cure and the following tapering schedule: one session per week for one month, then one session every two weeks for two months, then one session per month for three months. | Device | BT ECT |
Primary outcome
Change from baseline in the Q-LES-Q-SF score at Day 5
Time frame: From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)
Change in Q-LES-Q-SF score from inclusion to Day 5 (5 days after the last session of the acute phase treatment (Post treatment visit (D5 ± 2 days)). The total raw score ranges from 14 to 70. . The higher the score, the better the person's quality of life and self-reported satisfaction.
24 secondary outcomes
Changes in Hamilton Rating Scale for Depression-17 items (HDRS-17) scores from inclusion to end of study (EOS)
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Remission rate
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of responders at Day 5
Time frame: From enrollment date until the 5th day after the end of the acute treatment (Day 5), assessed up to 2 months and 3 weeks
Number of responders at Month 1
Time frame: From enrollment date until the Month 1 after the end of the acute treatment (M1), assessed up to 3,5 months
Number of responders at Month 6 (End of Study)
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of partial responders throughout the study
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Number of patients with a reduced score on the suicidal ideation item of the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study compared to inclusion
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Clinical Global Impression-Severity (CGI-S) and CGI-improvement (CGI-I) scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Columbia-Suicide Severity Rating Scale (C-SSRS) total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Quick Inventory of Depressive Symptomatology-Clinician rated (QIDS-C) total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
EQ-5D-5L total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Mean time to Orientation Recovery (TOR)
Time frame: From the end of the first session to the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Number of adverse Events (AE) during the sessions of the acute treatment
Time frame: From week 1 until week 6 (acute treatment), assessed up to 6 weeks
Patient VAS for memory disorders scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Assessor VAS for memory disorders scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
ElectroConvulsive therapy Cognitive Assessment (ECCA) total score
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Columbia Autobiographical Memory Interview-Short Form (AMI-SF) total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Montreal Cognitive Assessment (MoCA) total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Verbal Fluency test total scores
Time frame: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
Rate of planned ECT/FEAST sessions realized (%)
Time frame: From Week 1 (start of acute treatment) until the date of End of study visit(EOS), assessed up to From date of enrollment until the date of end of study visit (EOS), assessed up to 7,5 months
Mean EEG seizure duration
Time frame: From the end of the first session until the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Mean motor seizure duration
Time frame: From the end of the first session until the end of the last session (week 1 to week 6) of the acute treatment, assessed up to 6 weeks
Number of Spontaneous Abnormal Brain Currents (SABc) per group
Time frame: From the end of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
Rate of efficient electric or clinic crisis (%)
Time frame: From the date of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
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 5 Oct 2026.
- Individual participant dataSharing planned: No. GDPR in force in Europe and clinical trial :
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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.
Cécile MICHEL, MSc contact
Harold SACKHEIM, MD, PhD study chair
Department of Psychiatry and Behavioral Sciences College of Medicine Medical University of South Carolina (MUSC) Charleston, South Carolina, USA
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stimulation by the Sigma ECT/FEAST device, Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL) and Stimulation by Sigmastim ECT 200J device administered in bilateral (BT) in people with Major Depressive Episode (MDE) and Unipolar Disorder, run by Centre Hospitalier St Anne at 5 sites in 2 countries.
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 7 inclusion and 15 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Monaco. 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 Philippe DOMENECH, MD, PhD (+33 1 45 65 89 76, philippe.domenech@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Q-LES-Q-SF score at Day 5 (time frame: From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)). 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 5 Oct 2026.