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.
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;
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;
Parallel
Stimulation by the Sigma ECT/FEAST device
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.
Stimulation by Sigmastim ECT 200J device administered in right unilateral (RUL)
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.
Stimulation by Sigmastim ECT 200J device administered in bilateral (BT)
DeviceTitration 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.
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.
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.
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 %.
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.
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.
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Centre Hospitalier St Anne
Lead sponsor
Neuromodulation Institute
Collaborator
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