VIBRANT-IBD: Brain Effects of Non-Invasive Vagus Nerve Stimulation in IBD Remission (VIBRANT-IBD)
VIBRANT-IBD: Pilot fMRI Study on Neural Correlates of Non-Invasive Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease in Remission
The VIBRANT-IBD study is a pilot, prospective, single-arm feasibility study investigating the effects of non-invasive vagus nerve stimulation (nVNS) in adults with inflammatory bowel disease (IBD) in clinical remission.
Approximately 15 participants with Crohn's disease or ulcerative colitis will use the Nurosym auricular vagus nerve stimulation device daily for 28 days.
Participants will undergo two magnetic resonance imaging (MRI) sessions, one before and one after the intervention. The MRI protocol will include structural imaging, diffusion-weighted imaging, MR angiography, and resting-state functional MRI (rs-fMRI) to assess brain structure and functional connectivity. Before and after the intervention, participants will complete standardised psychological and study-specific questionnaires assessing stress, anxiety, depression, fatigue, emotional functioning, body awareness (interoception), quality of life, gastrointestinal symptom-related experiences, and perceived effects of the intervention. Optional qualitative interviews will additionally explore participants' experiences of living with IBD and using vagus nerve stimulation.
The study aims to evaluate the feasibility and preliminary neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation in individuals with IBD.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The VIBRANT-IBD study is a pilot, prospective, single-arm feasibility study designed to investigate the neuropsychological and neurofunctional effects of non-invasive vagus nerve stimulation (nVNS) in adults with inflammatory bowel disease (IBD) who are in clinical remission.
The study focuses on individuals diagnosed with Crohn's disease or ulcerative colitis and aims to explore the relationship between vagal neuromodulation, brain functional connectivity, emotional functioning, stress regulation, fatigue, and quality of life. Approximately 15 adult participants will be recruited from a gastroenterology outpatient clinic and hospital department.
Participants will undergo a 28-day intervention using the Nurosym device, a non-invasive auricular vagus nerve stimulation system. The stimulation will be self-administered daily following standardised instructions after participant training. The intervention involves stimulation of the auricular branch of the vagus nerve at the tragus area of the ear using mild electrical impulses. Stimulation will deliver at a frequency of 25 Hz with a pulse width of 250 µs. Stimulation intensity will be individually adjusted to a comfortable, clearly perceptible, non-painful level following standardized participant training. The total stimulation time will be 1.5 hours per day. The study aims to evaluate preliminary effects of this intervention, the feasibility, and acceptability in individuals with IBD in remission. Each participant will complete two magnetic resonance imaging sessions: one before the intervention and one after the 28-day stimulation period. MRI examinations will be performed using a 3T Magnetom Vida scanner equipped with a 64-channel head coil. The imaging protocol will include structural and functional neuroimaging assessments. Structural MRI will include standard anatomical imaging, high-resolution three-dimensional T1-weighted magnetisation-prepared rapid acquisition gradient echo (3D MPRAGE), diffusion-weighted imaging (DWI), and non-contrast MR angiography using the time-of-flight (TOF) technique. Functional magnetic resonance imaging (rs-fMRI) will be performed during resting-state conditions using T2-weighted Gradient Echo Echo-Planar Imaging (EPI) sequences to assess functional brain connectivity and neural networks.
Participants will also complete a set of standardised psychological questionnaires before and after the intervention. These measures will assess anxiety (DASS-21), depression (DASS-21), stress (DASS-21), fatigue (IBD-F), resilience (RS14), interoceptive awareness (Brief MAIA-2), and quality of life (WHOQoL BREF). In addition, study-specific questionnaires developed for the project will evaluate, e.g., disease-related concerns, fear of relapse, stress-related gastrointestinal symptoms, and daily functioning. Post-intervention assessments will additionally examine treatment adherence, usability, and acceptability of the stimulation device, perceived therapeutic effects, and potential side effects. Optional qualitative interviews will also be conducted with interested participants to explore personal experiences related to living with IBD and using vagus nerve stimulation therapy.
The primary objective of the study is to explore changes in brain functional connectivity following non-invasive vagus nerve stimulation in adults with IBD in remission. Secondary objectives are to evaluate the feasibility and safety of the intervention and to assess psychological outcomes, including associations between neuroimaging findings and psychological measures.
The study may contribute to a better understanding of brain-gut interactions and the potential role of neuromodulation as a supportive non-pharmacological intervention in IBD.
Тип исследования
Регистрация (Оцененный)
Фаза
- Ранняя фаза 1
Контакты и местонахождение
Места учебы
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Польша, 80-104
- Gastroenterology Department / Independent Public Healthcare Centre of the Ministry of Interior and Administration in Gdansk
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria
Participants must meet all of the following criteria to be eligible for participation:
- Adults aged 18 years or older.
- Diagnosis of inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis.
- Clinical remission of IBD confirmed by medical evaluation.
- Ability to provide informed consent.
- Ability to comply with study procedures and daily use of the stimulation device.
- No contraindications to magnetic resonance imaging (MRI).
- No contraindications to non-invasive vagus nerve stimulation (nVNS).
Exclusion Criteria
Participants meeting any of the following criteria will be excluded from the study:
- Active inflammatory bowel disease flare or clinically significant gastrointestinal symptoms.
- Severe or life-threatening comorbid medical conditions (e.g., active cancer).
- Contraindications to MRI, including metallic implants, pacemaker, or severe claustrophobia.
- Contraindications to nVNS, including significant cardiac arrhythmias, severe bradycardia, active implanted electronic medical devices, recent trigeminal neuralgia, or previous vagotomy.
- Current pregnancy.
- Diagnosed with severe neurological or psychiatric disorders.
- Ongoing changes in pharmacological treatment that may affect central nervous system functioning.
- Inability to comply with study procedures or complete study assessments.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Adults with IBD in clinical remission receiving non-invasive vagus nerve stimulation
This cohort includes adults (≥18 years) diagnosed with inflammatory bowel disease (IBD), including Crohn's disease or ulcerative colitis, who are in remission at the time of enrollment. Participants will be recruited from gastroenterology outpatient clinics and hospital departments. Participants will undergo a 28-day non-invasive auricular vagus nerve stimulation intervention using the Nurosym device. The intervention consists of daily self-administered stimulation of the auricular branch of the vagus nerve at the tragus region of the ear for approximately 1.5 hours per day following standardised training and instructions. Participants will complete two study visits, before and after the intervention period, including magnetic resonance imaging (MRI) assessments and psychological questionnaires. |
Participants will undergo non-invasive auricular vagus nerve stimulation (nVNS), also referred to as auricular vagal neuromodulation therapy (AVNT). The intervention is neuromodulatory and autonomic in nature and involves transcutaneous electrical stimulation of the auricular branch of the vagus nerve at the tragus region of the ear. The stimulation will be self-administered by participants at home after standardised training provided by the research team. The intervention period will last 28 consecutive days prior to the second MRI assessment. Participants will perform daily stimulation with a total target duration of 1.5 hours per day. A consistent 45-minute morning session will be required. Another session may be applied reactively during the day or in the evening hours. The total daily stimulation time should remain constant at 1.5 hours. Daily stimulation use, including session timing, duration, and adherence, will be recorded in a participant diary or device log. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Change in resting-state functional brain connectivity following non-invasive vagus nerve stimulation
Временное ограничение: Baseline and at least 28 days post-intervention
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Resting-state functional magnetic resonance imaging will be used to assess changes in functional connectivity between baseline (pre-intervention) and post-intervention measurements following 28 days of daily auricular non-invasive vagus nerve stimulation using the Nurosym device.
Analyses will focus on brain networks associated with emotional regulation, interoception, autonomic regulation, and stress processing.
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Baseline and at least 28 days post-intervention
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Change in structural brain imaging measures following non-invasive vagus nerve stimulation
Временное ограничение: Baseline and at least 28 days post-intervention
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Structural magnetic resonance imaging (MRI) assessments, including high-resolution 3D T1-weighted imaging (MPRAGE), diffusion-weighted imaging (DWI), and MR angiography, will be used to explore potential changes in brain morphology, microstructural integrity, and vascular characteristics between baseline and post-intervention measurements.
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Baseline and at least 28 days post-intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Qualitative assessment of participant experiences
Временное ограничение: Up to 1 week after Day 28 intervention completion
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Optional semi-structured qualitative interviews will explore participant experiences related to living with IBD and using vagus nerve stimulation therapy.
Interviews will be conducted up to one week after completion of the intervention, depending on participant availability.
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Up to 1 week after Day 28 intervention completion
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Change in anxiety, depression, and stress levels
Временное ограничение: Baseline and at least 28 days post-intervention
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Changes in psychological distress will be assessed using the Depression Anxiety Stress Scales-21 (DASS-21).
The DASS-21 is a 21-item self-report questionnaire measuring symptoms of depression, anxiety, and stress over the past week.
It includes three 7-item subscales.
Each item is rated from 0 to 3, and subscale scores are summed for each subscale, yielding raw subscale scores ranging from 0 to 21. Scores may also be multiplied by 2 to obtain scores comparable with the full 42-item DASS, resulting in subscale scores ranging from 0 to 42.
Higher Depression, Anxiety, or Stress scores indicate greater symptom severity in the respective domain.
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Baseline and at least 28 days post-intervention
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Change in fatigue severity
Временное ограничение: Baseline and at least 28 days post-intervention
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Fatigue-related symptoms and their impact on functioning will be assessed using the Inflammatory Bowel Disease Fatigue Scale (IBD-F).
The IBD-F Scale includes a section on fatigue severity, frequency, and duration, and a section on the impact of fatigue on daily functioning.
Items are scored from 0 to 4, with higher scores indicating greater fatigue or a greater impact of fatigue on everyday life.
The fatigue severity, frequency, and duration section has a maximum score of 20, while the impact of fatigue on daily functioning section has a maximum score of 120.
Higher scores reflect more severe fatigue-related symptoms and greater functional impact.
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Baseline and at least 28 days post-intervention
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Change in quality of life
Временное ограничение: Baseline and at least 28 days post-intervention
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Quality of life will be evaluated using the Polish version of the World Health Organization Quality of Life questionnaire, WHOQOL-BREF.
The WHOQOL-BREF is a short, generic self-report questionnaire.
The tool contains 26 items: 24 items grouped into four domains - physical health, psychological health, social relationships, and environment - plus two general items assessing overall quality of life and satisfaction with health.
Items are rated from 1 to 5, with higher scores generally indicating better quality of life.
Raw domain scores are calculated by summing the items within each domain: physical health has a maximum raw score of 35, psychological health has a maximum raw score of 30, social relationships has a maximum raw score of 15, and environment has a maximum raw score of 40.
The two general items are scored separately, each with a maximum score of 5. Domain scores may also be transformed to a 4-20 or 0-100 scale, with higher scores indicating better quality of life.
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Baseline and at least 28 days post-intervention
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Change in interoceptive awareness
Временное ограничение: Baseline and at least 28 days post-intervention
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The Brief Multidimensional Assessment of Interoceptive Awareness, version 2 (Brief MAIA-2), is a 24-item self-report questionnaire used to assess interoceptive awareness, meaning how a person perceives, attends to, interprets, and trusts internal bodily sensations.
The tool includes eight 3-item subscales: Noticing, Not Distracting, Not Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting.
Items are rated from 0 (never) to 5 (always).
Subscale scores are typically calculated as the mean of the three items in each subscale and therefore range from 0 to 5. If item scores are summed within each subscale, each 3-item subscale has a maximum score of 15, and the total maximum score across all 24 items is 120.
Higher scores indicate greater interoceptive awareness or a stronger ability to perceive and use bodily sensations.
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Baseline and at least 28 days post-intervention
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Change in psychological resilience
Временное ограничение: Baseline and at least 28 days post-intervention
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Psychological resilience will be measured using the Resilience Scale (RS-14).
The scale consists of 14 items, each rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree).
Total scores range from 14 to 98, with higher scores indicating higher resilience.
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Baseline and at least 28 days post-intervention
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Change in emotional functioning and stress-related gastrointestinal experiences
Временное ограничение: Baseline and at least 28 days post-intervention
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The self-constructed study-specific questionnaire will assess fear of disease relapse, emotional tension, stress-related gastrointestinal symptoms, body awareness, perceived control over health, psychosocial functioning, and expectations toward non-invasive vagus nerve stimulation.
It will also assess participants' general health status on a 1-10 scale, where 1 indicates very poor health and 10 indicates very good health.
Items are mainly rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with higher scores indicating stronger agreement with each statement.
As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
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Baseline and at least 28 days post-intervention
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Intervention adherence and usability
Временное ограничение: At least 28 days post-intervention
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Participant adherence, usability, comfort, and acceptability of the intervention will be assessed using a study-specific post-intervention questionnaire.
The questionnaire includes items on the frequency of stimulation, ease of device use, technical difficulties, perceived comfort, safety, willingness to continue therapy, and whether the participant would recommend it to others with IBD.
It will also assess participants' general health status on a 1-10 scale, where 1 indicates very poor health and 10 indicates very good health.
Most items are rated on a 5-point scale, with higher scores indicating more positive evaluation of the intervention.
The questionnaire also records perceived changes in well-being, IBD-related functioning, stress response, adverse effects, and open-ended feedback about the therapy experience.
As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
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At least 28 days post-intervention
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Occurrence of adverse events
Временное ограничение: At least 28 days post-intervention
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Occurrence of adverse events will be measured using the study-specific post-intervention questionnaire.
Participants will be asked whether any adverse events occurred during therapy, with multiple-choice response options including: no adverse events, discomfort at the stimulation site, headache, dizziness, fatigue, sleepiness, worsening of gastrointestinal symptoms, anxiety, and other symptoms specified by the participant.
Additional comments can be provided in an open-text field.
As a study-specific tool, it should be treated as an exploratory questionnaire rather than a standardised validated scale.
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At least 28 days post-intervention
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Соавторы и исследователи
Публикации и полезные ссылки
Общие публикации
- Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.
- Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.
- Czuber-Dochan W, Norton C, Bassett P, Berliner S, Bredin F, Darvell M, Forbes A, Gay M, Nathan I, Ream E, Terry H. Development and psychometric testing of inflammatory bowel disease fatigue (IBD-F) patient self-assessment scale. J Crohns Colitis. 2014 Nov;8(11):1398-406. doi: 10.1016/j.crohns.2014.04.013. Epub 2014 May 22.
- Skrobisz K, Piotrowicz G, Naumczyk P, Sabisz A, Markiet K, Rydzewska G, Szurowska E. Imaging of Morphological Background in Selected Functional and Inflammatory Gastrointestinal Diseases in fMRI. Front Psychiatry. 2020 May 20;11:461. doi: 10.3389/fpsyt.2020.00461. eCollection 2020.
- Skrobisz K, Piotrowicz G, Drozdowska A, Markiet K, Sabisz A, Naumczyk P, Rydzewska G, Szurowska E. Use of functional magnetic resonance imaging in patients with irritable bowel syndrome and functional dyspepsia. Prz Gastroenterol. 2019;14(3):163-167. doi: 10.5114/pg.2019.88163. Epub 2019 Sep 27.
- Bonaz B, Bazin T, Pellissier S. The Vagus Nerve at the Interface of the Microbiota-Gut-Brain Axis. Front Neurosci. 2018 Feb 7;12:49. doi: 10.3389/fnins.2018.00049. eCollection 2018.
- Sarb OF, Sarb AD, Leucuta D, Brisc C, Tantau AI. Predictors of Stress, Anxiety, Depression and Quality of Life in Patients Diagnosed with Chronic Inflammatory Bowel Disease in Romania: A Cross-Section Observational Case-Report Study. J Clin Med. 2026 Mar 5;15(5):1996. doi: 10.3390/jcm15051996.
- Ciorba MA, Konnikova L, Hirota SA, Lucchetta EM, Turner JR, Slavin A, Johnson K, Condray CD, Hong S, Cressall BK, Pizarro TT, Hurtado-Lorenzo A, Heller CA, Moss AC, Swantek JL, Garrett WS. Challenges in IBD Research 2024: Preclinical Human IBD Mechanisms. Inflamm Bowel Dis. 2024 May 23;30(Suppl 2):S5-S18. doi: 10.1093/ibd/izae081.
- Radford SJ, McGing J, Czuber-Dochan W, Moran G. Systematic review: the impact of inflammatory bowel disease-related fatigue on health-related quality of life. Frontline Gastroenterol. 2020 Jan 24;12(1):11-21. doi: 10.1136/flgastro-2019-101355. eCollection 2021.
- Liebert A, Wilenska A, Czuber-Dochan W, Klopocka M. Translation and validation of the inflammatory bowel disease fatigue (IBD-F) patient self-assessment questionnaire. Prz Gastroenterol. 2021;16(2):136-143. doi: 10.5114/pg.2021.106665. Epub 2021 Jun 4.
- Radford SJ, Moran GW, Czuber-Dochan W. The impact of Inflammatory Bowel Disease related fatigue on Health-Related Quality of Life: a qualitative semi-structured interview study. J Res Nurs. 2022 Dec;27(8):685-702. doi: 10.1177/17449871211061048. Epub 2022 Jul 5.
- Lommano MG, Farah S, Bianchi B, Risa AM, Sarzi-Puttini P, Salaffi F, Di Carlo M. Non-invasive auricular vagus nerve stimulation in fibromyalgia: Impacts on autonomic function, central sensitization and pain catastrophizing. Joint Bone Spine. 2026 Jan;93(1):105966. doi: 10.1016/j.jbspin.2025.105966. Epub 2025 Sep 9.
- Rogowska AM, Tataruch R, Klimowska K. Validation of the shortened 24-item multidimensional assessment of interoceptive awareness, version 2 (Brief MAIA-2). Sci Rep. 2023 Dec 2;13(1):21270. doi: 10.1038/s41598-023-48536-0.
- Makara-Studzinska M, Tyburski E, Zaluski M, Adamczyk K, Mesterhazy J, Mesterhazy A. Confirmatory Factor Analysis of Three Versions of the Depression Anxiety Stress Scale (DASS-42, DASS-21, and DASS-12) in Polish Adults. Front Psychiatry. 2022 Jan 4;12:770532. doi: 10.3389/fpsyt.2021.770532. eCollection 2021.
- Jaracz K, Kalfoss M, Gorna K, Baczyk G. Quality of life in Polish respondents: psychometric properties of the Polish WHOQOL-Bref. Scand J Caring Sci. 2006 Sep;20(3):251-60. doi: 10.1111/j.1471-6712.2006.00401.x.
- Surzykiewicz J, Konaszewski K, Wagnild G. Polish Version of the Resilience Scale (RS-14): A Validity and Reliability Study in Three Samples. Front Psychol. 2019 Jan 17;9:2762. doi: 10.3389/fpsyg.2018.02762. eCollection 2018.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- KB 17/26
- 2025 (Грант/контракт NIH США: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025/09/X/HS6/01840 (Другой номер гранта/финансирования: Polish National Science Centre (NCN))
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .