Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial (FEAST-AFT)
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Philippe DOMENECH, MD, PhD
- Numero di telefono: +33 1 45 65 89 76
- Email: philippe.domenech@ghu-paris.fr
Backup dei contatti dello studio
- Nome: Cécile MICHEL, MSc
- Email: cecile.bultez@ghu-paris.fr
Luoghi di studio
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Bron, Francia, 69678
- CH Le Vinatier
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Contatto:
- Filipe GALVAO, MD
- Email: Filipe.GALVAO@ch-le-vinatier.fr
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Investigatore principale:
- Filipe GALVAO, MD
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Sub-investigatore:
- Julien ECHE, MD
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Nantes, Francia, 44000
- CHU Nantes
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Contatto:
- Anne Sauvaget, MD, PhD
- Email: anne.sauvaget@chu-nantes.fr
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Paris, Francia, 75014
- GHU Paris Psychiatrie & Neurosciences - Neuromodulation Institute
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Investigatore principale:
- Philippe Domenech, MD, PhD
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Contatto:
- Philippe Domenech, MD, PhD
- Numero di telefono: +33 1 45 65 89 76
- Email: philippe.domenech@ghu-paris.fr
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Contatto:
- Mickaël AMAGAT, MD
- Email: m.amagat@ghu-paris.fr
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Sub-investigatore:
- Mickaël Amagat, MD
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Sotteville-lès-Rouen, Francia, 76300
- CH du Rouvray
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Contatto:
- Maud ROTHARMEL, MD
- Email: maud.rotharmel@ch-lerouvray.fr
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Investigatore principale:
- Maud ROTHARMEL, MD
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Monaco, Monaco, 98000
- CH Princesse Grace de Monaco
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Investigatore principale:
- David SZEKELY, MD
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Contatto:
- David SZEKELY, MD
- Email: david.szekely@chpg.mc
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: FEAST
FEAST stimulation administered with 2 electrodes with Ultrabrief Parameter Set (initial values of 0.30 ms) |
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. |
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Comparatore attivo: RUL ECT
ECT stimulation administered in right unilateral with Ultra Brief pulse (0.3 ms) |
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. |
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Comparatore attivo: BT ECT
ECT stimulation administered in bilateral with brief pulse (1 ms) |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change from baseline in the Q-LES-Q-SF score at Day 5
Lasso di tempo: From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)
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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. |
From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)
|
Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Changes in Hamilton Rating Scale for Depression-17 items (HDRS-17) scores from inclusion to end of study (EOS)
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Remission rate
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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 %. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Number of responders at Day 5
Lasso di tempo: From enrollment date until the 5th day after the end of the acute treatment (Day 5), assessed up to 2 months and 3 weeks
|
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. |
From enrollment date until the 5th day after the end of the acute treatment (Day 5), assessed up to 2 months and 3 weeks
|
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Number of responders at Month 1
Lasso di tempo: From enrollment date until the Month 1 after the end of the acute treatment (M1), assessed up to 3,5 months
|
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. |
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)
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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). |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Number of partial responders throughout the study
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
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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 |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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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
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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 |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Clinical Global Impression-Severity (CGI-S) and CGI-improvement (CGI-I) scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Columbia-Suicide Severity Rating Scale (C-SSRS) total scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Quick Inventory of Depressive Symptomatology-Clinician rated (QIDS-C) total scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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EQ-5D-5L total scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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Mean time to Orientation Recovery (TOR)
Lasso di tempo: 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
|
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. |
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
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Number of adverse Events (AE) during the sessions of the acute treatment
Lasso di tempo: From week 1 until week 6 (acute treatment), assessed up to 6 weeks
|
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 |
From week 1 until week 6 (acute treatment), assessed up to 6 weeks
|
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Patient VAS for memory disorders scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
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
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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ElectroConvulsive therapy Cognitive Assessment (ECCA) total score
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
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
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
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
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
|
Verbal Fluency test total scores
Lasso di tempo: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months
|
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. |
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 (%)
Lasso di tempo: 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
|
Number of ECT/FEAST sessions realized compared to the total number of planned ECT/FEAST sessions (%). Causes of sessions not realized will be described. |
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
Lasso di tempo: 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 of EEG seizure duration per session (in seconds). |
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
Lasso di tempo: 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 of motor seizure duration per session (in seconds). |
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
Lasso di tempo: From the end of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
|
SABc will be recorded as present or absent. The number of SABc present in each group will be analyzed |
From the end of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
|
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Rate of efficient electric or clinic crisis (%)
Lasso di tempo: From the date 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 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) |
From the date of the first session (Week 1) until the date of the End of Study (EOS), assessed up to 7,5 months
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Investigatori
Investigatori
- Cattedra di studio: Harold SACKHEIM, MD, PhD, Department of Psychiatry and Behavioral Sciences College of Medicine Medical University of South Carolina (MUSC) Charleston, South Carolina, USA
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- D25-P040
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
GDPR in force in Europe and clinical trial :
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
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prodotto fabbricato ed esportato dagli Stati Uniti
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