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Evaluating the Therapeutic Potential of Focal Electrically Administered Seizure Therapy (FEAST) in the Treatment of Depression: A Multicenter Randomized Clinical Trial (FEAST-AFT)

2026년 9월 28일 업데이트: Centre Hospitalier St Anne

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

108

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Monaco, 모나코, 98000
        • CH Princesse Grace de Monaco
        • 수석 연구원:
          • David SZEKELY, MD
        • 연락하다:
      • Bron, 프랑스, 69678
        • CH Le Vinatier
        • 연락하다:
        • 수석 연구원:
          • Filipe GALVAO, MD
        • 부수사관:
          • Julien ECHE, MD
      • Nantes, 프랑스, 44000
      • Paris, 프랑스, 75014
        • GHU Paris Psychiatrie & Neurosciences - Neuromodulation Institute
        • 수석 연구원:
          • Philippe Domenech, MD, PhD
        • 연락하다:
        • 연락하다:
        • 부수사관:
          • Mickaël Amagat, MD
      • Sotteville-lès-Rouen, 프랑스, 76300

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

활성 비교기: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from baseline in the Q-LES-Q-SF score at Day 5
기간: 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.

From enrollment to the 5 days after the last session of the acute phase treatment (Day 5)

2차 결과 측정

결과 측정
측정값 설명
기간
Changes in Hamilton Rating Scale for Depression-17 items (HDRS-17) scores from inclusion to end of study (EOS)
기간: 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
Remission rate
기간: 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
Number of responders at Day 5
기간: 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
Number of responders at Month 1
기간: 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)
기간: 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
Number of partial responders throughout the study
기간: From date of enrollment until the date of end of study visit (EOS), assessed up to 8,5 months

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
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
기간: 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
Clinical Global Impression-Severity (CGI-S) and CGI-improvement (CGI-I) scores
기간: 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
Columbia-Suicide Severity Rating Scale (C-SSRS) total scores
기간: 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
Quick Inventory of Depressive Symptomatology-Clinician rated (QIDS-C) total scores
기간: 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
EQ-5D-5L total scores
기간: 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
Mean time to Orientation Recovery (TOR)
기간: 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
Number of adverse Events (AE) during the sessions of the acute treatment
기간: 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
Patient VAS for memory disorders scores
기간: 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
기간: 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
ElectroConvulsive therapy Cognitive Assessment (ECCA) total score
기간: 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
기간: 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
기간: 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
기간: 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 (%)
기간: 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
기간: 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
기간: 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
기간: 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
Rate of efficient electric or clinic crisis (%)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 연구 의자: Harold SACKHEIM, MD, PhD, Department of Psychiatry and Behavioral Sciences College of Medicine Medical University of South Carolina (MUSC) Charleston, South Carolina, USA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 11월 2일

기본 완료 (추정된)

2030년 1월 2일

연구 완료 (추정된)

2030년 7월 2일

연구 등록 날짜

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2026년 9월 17일

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2026년 10월 5일

연구 기록 업데이트

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2026년 9월 1일

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이 연구와 관련된 용어

기타 연구 ID 번호

  • D25-P040

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

GDPR in force in Europe and clinical trial :

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

미국에서 제조되어 미국에서 수출되는 제품

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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