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Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI (ESBo-SCI)

2026年11月5日 更新者：Swiss Paraplegic Research, Nottwil

ESBo-SCI: Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI

Difficulty with bowel movements is one of the most serious side effects of spinal cord injury and one that most severely restricts everyday life. Many people affected take 30 to 60 minutes, or considerably longer, to pass stools. This is accompanied by a significantly slowed bowel transit, which often leads to a feeling of fullness, flatulence and chronic pain. The study investigates a method suitable for everyday use to support bowel function: electrical stimulation of the abdominal muscles. This involves applying adhesive electrodes to the abdomen and controlling them via a small device. The treatment is carried out independently at home - 30 minutes before each planned bowel movement. Two stimulation settings are being compared: i) Motor stimulation: The current strength causes a noticeable contraction of the abdominal muscles. ii) Sensory stimulation: The intensity is lower and is perceived merely as a gentle tingling sensation. The procedure is divided into several phases. Before stimulation begins, baseline values are recorded during a two-week pre-observation phase. Subsequently, both stimulation methods are applied one after the other for 12 weeks each, interspersed with a six-week break without stimulation. Which participant starts with which type of stimulation is determined at random. A final six-week follow-up phase assesses whether any improvements achieved persist after the end of treatment.

During the study, participants will keep a diary and, together with specialists, complete two questionnaires. Bowel transit time will be measured in a simple and safe manner (using maize grains and a capsule containing blue food colouring). In addition, stool samples will be collected at five specified time points to analyse changes in the gut microbiota. The aim is to evaluate a gentle, practical method that facilitates the bowel movement process, promotes gut health and noticeably improves the quality of life of people with spinal cord injury.

研究概览

地位

地位

指示当前招聘状态或扩展访问状态。
尚未招聘

条件

条件

正在研究的疾病、紊乱、综合征、疾病或损伤。在 ClinicalTrials.gov 上，条件还可能包括其他与健康相关的问题，例如寿命、生活质量和健康风险。

干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。

详细说明

Neurogenic Bowel Dysfunction (NBD) is a debilitating complication affecting the majority of individuals with spinal cord injury (SCI), resulting from disrupted autonomic and somatic neural pathways regulating colonic peristalsis and sphincter control. Clinically, NBD manifests as prolonged defecation routines, severe constipation, fecal incontinence, and abdominal distension, with approximately 55% of individuals reporting moderate to severe deterioration in quality of life due to restrictive routines, anxiety over accidental episodes, and caregiver dependency. In severe cases, bowel management requires several hours each day and represents a leading source of secondary morbidity and hospital readmission. In addition, prolonged gastrointestinal transit in SCI alters the gut luminal environment, causing mucosal dysbiosis, depletion of beneficial short-chain fatty acid-producing taxa, and accumulation of potentially deleterious proteolytic fermentation metabolites.

Neuromuscular electrical stimulation (NMES) applied to the abdominal wall musculature is a non-invasive intervention designed to improve bowel function. Historically, abdominal NMES has been applied at suprathreshold intensities to trigger visible tetanic muscle contractions, based on the premise that increased intra-abdominal pressure mechanically facilitates colonic transit and defecation. However, pilot findings and emerging neurophysiological data indicate that sub-motor (sensory) stimulation may independently modulate autonomic enteric pathways via afferent sensory signaling to the spinal cord. In a preliminary single-center pilot trial (NCT04914975, N = 20), daily home-based abdominal NMES applied for 30 minutes prior to scheduled bowel care significantly reduced defecation time and whole-gut transit time. Notably, participants with neurological injury levels below T12 who possessed intact voluntary abdominal motor control also derived clinical benefits, indicating that the underlying mechanisms extend beyond mechanical efferent activation to include sensory afferent neuromodulation.

The ESBo-SCI trial is a randomized, active-controlled, two-period cross-over clinical trial designed to compare the clinical and physiological efficacy of motor-level versus sensory-level abdominal NMES in individuals with chronic SCI. The protocol spans an overall duration of 38 weeks. Following a 2-week standardized baseline phase of prospective documentation without electrical stimulation, participants complete a 12-week intervention period (Stimulation Block I) with either motor NMES or sensory NMES as determined by randomization. This is followed by a 6-week washout phase without electrical stimulation to eliminate potential carry-over effects. Participants then cross over to the alternate stimulation modality for a second 12-week intervention period (Stimulation Block II), concluding with a 6-week follow-up observation phase to determine the durability and persistence of treatment effects. Throughout both 12-week intervention blocks, participants self-administer the stimulation at home for 30 minutes immediately preceding their scheduled bowel routine using certified, current-controlled clinical stimulators. Electrical current intensity is individualized through on-site threshold testing prior to initiating each stimulation block. The motor threshold is defined as the lowest current intensity eliciting a visible muscle twitch within the stimulated area. For the sensory NMES modality, the current amplitude is fixed at 10% below this motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction. For the motor NMES modality, current amplitude is adjusted above the motor threshold to evoke visible, robust, tetanic abdominal muscle contractions that remain comfortable and tolerable to the participant.

Participants are randomized in a 1:1 allocation to determine the sequence of interventions (motor NMES first versus sensory NMES first).

Laboratory personnel and statisticians remain blinded to treatment sequence and stimulation modality. Participants are masked to the primary study hypotheses and sequence allocation, remaining uninformed regarding which stimulation mode is hypothesized to be superior. The primary hypothesis posits that motor NMES produces a significantly greater reduction in defecation time than sensory NMES, mediated primarily by mechanical intra-abdominal pressure generation combined with efferent motor contractions. The mechanistic hypothesis posits that if sensory NMES yields equivalent or superior clinical improvements, therapeutic benefits will be attributed primarily to afferent somatosensory neuromodulation acting on autonomic spinal and enteric circuits.

A total target enrollment of 41 participants is planned to account for anticipated attrition and provide 33 evaluable participants, ensuring statistical power to detect a clinically meaningful difference in defecation time. Differences between stimulation modalities and study phases will be analyzed using repeated-measures linear mixed-effects models with a random intercept for individual participants, treating the first week of each intervention block as an accommodation run-in phase. All prospective participant logs and clinical questionnaires are managed through an encrypted, web-based electronic data capture system using dedicated tablet computers.

研究类型

研究类型

描述临床研究的性质。研究类型包括介入性研究（也称为临床试验）、观察性研究（包括患者登记）和扩展访问。
介入性

注册 (估计的)

注册

临床研究的参与者人数。 “预期”入组人数是研究人员进行研究所需的目标参与者人数。
41

阶段

阶段

根据美国食品和药物管理局 (FDA) 制定的定义，研究药物或生物制品的临床试验阶段。阶段基于研究的目标、参与者的数量和其他特征。有五个阶段：早期第 1 阶段（以前列为第 0 阶段）、第 1 阶段、第 2 阶段、第 3 阶段和第 4 阶段。不适用用于描述没有 FDA 定义的阶段的试验，包括设备试验或行为干预。
  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习联系方式

可以回答临床研究注册问题的人员的姓名和联系信息。进行研究的每个地点也可能有特定的联系人，他们可能能够更好地回答这些问题。

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

资格标准

想要参加临床研究的人必须满足的关键要求或他们必须具备的特征。资格标准包括纳入标准（一个人参与研究所必需的）和排除标准（阻止一个人参与）。资格标准的类型包括一项研究是否接受健康志愿者、是否有年龄或年龄组要求，或是否受性别限制。

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Traumatic or non-traumatic spinal cord injury.
  • Neurological level of injury C1 to L5.
  • American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C, or D.
  • Chronicity ≥1 year post-injury.
  • Age ≥18 years.
  • Documented defecation time >30 minutes per routine with an expressed desire to reduce time spent on bowel care.
  • Established and stable conservative bowel management protocol.
  • Signed informed consent

Exclusion Criteria:

  • Active chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • Concurrent regular opioid therapy.
  • Active malignant disease in the abdominal or pelvic region.
  • Patients currently undergoing primary acute rehabilitation.
  • Presence of an implanted sacral anterior root stimulator (Brindley stimulator).
  • Prior surgical diversion of the gastrointestinal tract (e.g., colostomy, ileostomy).
  • Pregnancy (confirmed via urine pregnancy test in females of childbearing potential aged 18-49 years).
  • Open skin lesions or active dermatological defects at designated electrode placement sites.
  • Exacerbation of severe autonomic dysreflexia provoked during electrical stimulation testing.
  • Inability to comply with study protocols or operate the device due to substantial cognitive deficits or language barriers.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：双倍的

武器和干预

参与者组/臂

参与者组/臂

根据试验方案，接受特定干预/治疗或不接受干预的临床试验参与者组或亚组。
干预/治疗

干预/治疗

作为临床研究重点的过程或行动。干预措施包括药物、医疗设备、程序、疫苗和其他处于研究阶段或已经可用的产品。干预措施还可以包括非侵入性方法，例如教育或调整饮食和锻炼。
有源比较器：Sensory NMES Modality

Stimulation is delivered via two independent channels using four self-adhesive surface electrodes placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles. Stimulation is administered with a symmetrical rectangular biphasic current, 40 Hz, 300 µs.

Threshold testing is performed at on-site visits prior to initiating each stimulation block:

Motor Threshold Definition: The lowest electrical current intensity eliciting a visible muscle twitch within the stimulated abdominal area.

In this modality, the sensity modality, the current amplitude is fixed at 10% below the individually determined motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction.

Participants will stimulate with their individually determined amplitude.
其他：Motor NMES Modality

Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles.

  • Current Type: Symmetrical rectangular biphasic current.
  • Frequency: 40 Hz.
  • Pulse Duration: 300 microseconds (µs).
  • Duty Cycle: 8 seconds ON (incorporating 2 seconds ramp-up and 2 seconds ramp-down) followed by 3 seconds OFF.

Motor NMES Modality: Current amplitude is adjusted above motor threshold to evoke a visible, robust, tetanic abdominal muscle contraction that remains comfortable and tolerable to the participant.
有源比较器：Motor NMES Modality

Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles.

Current Type: Symmetrical rectangular biphasic current. Frequency: 40 Hz. Pulse Duration: 300 microseconds (µs). Duty Cycle: 8 seconds ON (incorporating 2 seconds ramp-up and 2 seconds ramp-down) followed by 3 seconds OFF.

In this modality, the motor NMES modality, the current amplitude is adjusted above motor threshold to evoke a visible, robust, tetanic abdominal muscle contraction that remains comfortable and tolerable to the participant.

Participants will stimulate with their individually determined amplitude, that is above the sensory threshold.
其他：Sensory NMES Modality

Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles.

  • Current Type: Symmetrical rectangular biphasic current.
  • Frequency: 40 Hz.
  • Pulse Duration: 300 µs.

Threshold testing is performed at on-site visits prior to initiating each stimulation block:

  • Motor Threshold Definition: The lowest electrical current intensity eliciting a visible muscle twitch within the stimulated abdominal area.
  • Sensory NMES Modality: Current amplitude is fixed at 10% below the individually determined motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction.

研究衡量的是什么？

主要结果指标

主要结果指标

在临床研究的方案中，对于评估干预/治疗的效果最重要的计划结果测量。大多数临床研究有一项主要结果指标，但有些研究有不止一项。
结果测量
措施说明
大体时间
Defecation time
大体时间：Defecation time will be assessed with a stool diary over the entire study period of 38 week depending on the bowel movements per week.

Defined as the elapsed duration from the expulsion of the first stool until the expulsion of the last stool. Participants prospectively record precise timestamps for each bowel routine in a daily electronic diary. The primary endpoint is the intra-individual change in mean weekly defecation time between baseline and the two stimulation modalities (excluding the first week of each stimulation block as a run-in phase).
Defecation time will be assessed with a stool diary over the entire study period of 38 week depending on the bowel movements per week.
Defecation Time (Minutes)
大体时间：Defecation will be assessed in form of a diary over the entire study period of 38 weeks depending on the number of defecation sessions per week

Defined as the elapsed duration from the expulsion of the first stool until the expulsion of the last stool. Participants prospectively record precise timestamps for each bowel routine in a daily electronic diary. The primary endpoint is the intra-individual change in mean weekly defecation time between baseline and the two stimulation modalities (excluding the first week of each stimulation block as a run-in phase).
Defecation will be assessed in form of a diary over the entire study period of 38 weeks depending on the number of defecation sessions per week

次要结果测量

次要结果测量

在临床研究的方案中，计划的结果测量值在评估干预效果时不如主要结果测量值重要，但仍然值得关注。大多数临床研究有不止一项次要结果指标。
结果测量
措施说明
大体时间
Whole-Gut Transit Time (WGTT)
大体时间：The Blue Dye Test will performed 5 times over the entire study period of 38 weeks.

Evaluated using a validated home test administered prior to study visits:

Standardized Blue Dye Test: Following an overnight fast (≥8 hours), participants ingest two plain rice crackers and swallow a single 0.68 mL gelatin capsule containing 0.25 g food-grade blue dye powder (~60 mg combined E131/E132; Hollinger Farbpulver Blau) with ~100 mL water. Diet, activity, and bowel medications remain unchanged, with intensely colored foods avoided for 48 hours. WGTT is defined as the duration between capsule ingestion and the first appearance of blue or blue-green stool.
The Blue Dye Test will performed 5 times over the entire study period of 38 weeks.
Whole-Gut Transit Time (WGTT)
大体时间：The Corn Test will performed 5 times over the entire study period of 38 weeks.

Evaluated using a validated home test administered prior to study visits:

Corn Test: Ingestion of 140 g of canned sweetcorn; elapsed time to the first visual identification of excreted corn kernels is recorded.
The Corn Test will performed 5 times over the entire study period of 38 weeks.
Stool Consistency
大体时间：The BSFS is included in the stool diary and will be filled in at the every defecation time point over the entire study period of 38 weeks.

Bristol Stool Form Scale (BSFS; range: Type 1 [separate hard lumps] to Type 7 [entirely liquid]), logged per defecation event
The BSFS is included in the stool diary and will be filled in at the every defecation time point over the entire study period of 38 weeks.
Neurogenic Bowel Dysfunction (NBD) Score
大体时间：The NBD score will be assessed 5 times over the entire study period of 38 weeks.

Validated 10-item clinical questionnaire assessing fecal incontinence, constipation, defecation duration, medication dependence, and lifestyle restriction (total score 0 to 47; higher scores indicate greater severity).
The NBD score will be assessed 5 times over the entire study period of 38 weeks.
Gastrointestinal Quality of Life Index (GIQLI)
大体时间：The GIQLI will be assessed 5 times over the entire study period of 38 weeks.

Total Score Range: 0 to 144 points (derived from 36 items, each rated on a 5-point Likert scale from 0 to 4).

Higher scores indicate a better quality of life, meaning fewer symptoms and better daily functioning.

Disease-specific health-related quality of life instrument evaluating gastrointestinal symptoms, physical functioning, emotional state, social performance, and medical treatment burden.
The GIQLI will be assessed 5 times over the entire study period of 38 weeks.
Gut Microbiome Profiling
大体时间：The Gut Microbiome Profiling consisting of stool probes will be assessed 5 times over the entire study period of 38 weeks.

Fecal samples are collected at scheduled visits using ambient-temperature DNA stabilization kits (DNA Genotek) or home frozen at -20°C prior to transport on cold packs and storage at -80°C. Stool aliquots undergo enzymatic pre-lysis and bead-beating prior to silica-membrane DNA purification. Full-length 16S rRNA genes (V1-V9 regions, ~1.5 kb) are amplified (primers 27F/1492R) and sequenced on Oxford Nanopore MinION platforms. Sequences are demultiplexed, filtered (Q ≥ 10; 1,400-1,650 bp), and taxonomically classified against the SILVA 138 database to quantify alpha/beta diversity and relative abundance of short-chain fatty acid-producing versus inflammation-associated taxa.
The Gut Microbiome Profiling consisting of stool probes will be assessed 5 times over the entire study period of 38 weeks.
Defecation Diary Metrics-absolut defecation time
大体时间：The diary will be filled in electronically on daily base over the entire study period of 38 weeks.

Daily tracking includes time of routine initiation, first stool expulsion, last stool expulsion as the absolute defecation time.
The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-relative defecation time
大体时间：The diary will be filled in electronically on daily base over the entire study period of 38 weeks.

Daily tracking includes time of clean-up start and completion to calculate the relative defecation time.
The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-rountinely defecation interventions
大体时间：The diary will be filled in electronically on daily base over the entire study period of 38 weeks.

Daily tracking includes time of individual defecation interventions
The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-stimulation parameter
大体时间：The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.

The diary includes the stimulation parameter in terms of intensity (amplitude mA)
The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Defecation Diary Metrics-stimulation time
大体时间：The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.

The diary includes the stimulation time (minutes)
The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Defecation Diary Metrics-stimulation posture
大体时间：The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.

The diary includes participants' posture during stimulation
The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Nutritional Confounders
大体时间：The Nutritional Confounders will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).

Dietary intake is assessed by using the Cambridge Food Frequency Questionnaire (FFQ).
The Nutritional Confounders will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder frequency of physical activity
大体时间：This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).

Frequency of weekly physical activity will be documented
This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder duration of physical activity
大体时间：This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).

Duration of weekly physical activity will be documented
This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder type of physical activity
大体时间：This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).

Type of weekly physical activity will be documented
This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

赞助

发起研究并有权和控制研究的组织或个人。
Swiss Paraplegic Research, Nottwil

调查人员

调查人员

参与临床研究的研究人员。相关术语包括中心首席研究员、中心副研究员、研究主席、研究主管和研究首席研究员。
  • 首席研究员：Ines Bersch, PhD、Swiss Paraplegic Research, Nottwil

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

学习开始

第一位参与者参加临床研究的实际日期。 “预期”研究开始日期是研究人员认为将成为研究开始日期的日期。
2027年1月1日

初级完成 (估计的)

初级完成

临床研究的最后一名参与者接受检查或接受干预以收集主要结果测量的最终数据的日期。临床研究是否根据方案结束或被终止不影响该日期。对于具有多个不同完成日期的主要结果测量的临床研究，该术语是指完成所有主要结果测量的数据收集的日期。 “预期”主要完成日期是研究人员认为将成为研究主要完成日期的日期。
2030年12月31日

研究完成 (估计的)

研究完成

临床研究中最后一位参与者接受检查或接受干预/治疗以收集主要结局指标、次要结局指标和不良事件（即最后一位参与者的最后一次就诊）的最终数据的日期。 “预期”研究完成日期是研究人员认为将成为研究完成日期的日期。
2030年12月31日

研究注册日期

首次提交

首次提交

研究发起人或研究者首次向 ClinicalTrials.gov 提交研究记录的日期。在首次提交日期和记录在 ClinicalTrials.gov 上的可用性（首次发布日期）之间通常会有几天的延迟。
2026年10月8日

首先提交符合 QC 标准的

首先提交符合 QC 标准的

研究发起人或研究者首次提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录的日期。在满足 NLM 的 QC 审查标准之前，发起人或研究者可能需要修改和提交研究记录一次或多次。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月5日

首次发布 (实际的)

首次发布

在国家医学图书馆 (NLM) 质量控制 (QC) 审查结束后，研究记录首次在 ClinicalTrials.gov 上可用的日期。研究发起人或研究者提交研究记录的日期与首次发布日期之间通常会有几天的延迟。
2026年11月10日

研究记录更新

最后更新发布 (实际的)

最后更新发布

在 ClinicalTrials.gov 上提供研究记录更改的最近日期。研究发起人或研究者向 ClinicalTrials.gov 提交变更的时间（最后更新提交日期）和最后更新发布日期之间可能会有延迟。
2026年11月10日

上次提交的符合 QC 标准的更新

上次提交的符合 QC 标准的更新

研究发起人或研究者提交符合国家医学图书馆 (NLM) 质量控制 (QC) 审查标准的研究记录更改的最近日期。申办者或研究者有责任确保研究记录符合 NLM QC 审查标准。
2026年11月5日

最后验证

最后验证

研究发起人或研究者确认 ClinicalTrials.gov 上的临床研究信息准确且最新的最近日期。如果一项研究的招募状态为招募；尚未招聘；或活跃，未在过去 2 年内确认招募，该研究的招募状态显示为未知。
2026年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

其他研究编号

由研究的发起人、资助者或其他人分配给临床研究的标识符或 ID 号，而不是 NCT 号。这些编号可能包括来自其他试验登记处的唯一标识符和美国国立卫生研究院的资助编号。
  • 2026-01772
  • 10.007.423 (其他赠款/资助编号：Swiss National Science Foundation)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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