Efficacy of Non-invasive Vagus Nerve Stimulation for Treatment of Low Weight Eating Disorders
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: taVNS, Sham.
- Кому может быть актуально
- Состояния в реестре: Anorexia Nervosa. Базовые параметры: 14 лет — 22 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This project includes a 4-week randomized trial comparing pre-meal vagal nerve stimulation (taVNS) to pre-meal sham stimulation. The aims will assess if taVNS results in greater satisfaction, greater calorie consumption, less self-reported fullness, decrease in eating disorder symptoms, and less anxiety than sham stimulation.
Подробное описание
The purpose of this research study is to determine the safety and ability of a device that will stimulate the vagus nerve (taVNS), in 30 adolescents ages 14-17. This project will explore if stimulation has any effect on eating behaviors in individuals with eating disorders, such as Anorexia Nervosa. Study measurements include eating behavior and other measures of behavior. These measurements will take place before and in response to the nerve stimulation during the course of a 4-week randomized trial.
Participants are assigned to one of two conditions: 1) Vagal Nerve Stimulation (n=20; this group includes use of the vagus nerve stimulator with stimulation); and 2) Sham Stimulation (n=10; this group includes use of the vagus nerve stimulator with no stimulation). Screening to determine eligibility includes physical measurements of height and weight, interview questions to determine inclusion/exclusion criteria and eating disorder diagnoses, and online REDCap surveys.
If eligible, participants will be scheduled for 5 study visits. Procedures will include taVNS, single item meals, check-ins during treatment in the Eating and Weight Disorders Program, and self-report questionnaires.
Clinic check-ins (3 days per week while in the clinic during the 4 week intervention) will include taVNS stimulation or sham for 30 minutes. Study Visits (4 weekly study visits lasting 1 hour each) will include a single item meal test, self-report surveys, and adverse event assessment and documentation. The follow-up visit, lasting 1 hour, will take place 1 week after the final study visit and includes self-report surveys and adverse event assessment and documentation.
Вмешательства
- Устройство taVNS
Participants will receive vagal nerve stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program. - Устройство Sham
Participants will receive sham stimulation approximately 3 days a week for 30 minutes over the course of 4 weeks while they are attending treatment for Anorexia Nervosa in the Eating and Weight Disorder Intensive Program.
Первичные конечные точки
- Satisfaction Rating Scale [Срок оценки: 4 weeks]
Вторичные конечные точки (12)
- Percent of participants with treatment-related adverse events [Срок оценки: 4 weeks]
- Dropout Rate [Срок оценки: 4 weeks]
- Total calories consumed [Срок оценки: up to 4 weeks]
- Change in weight from baseline to 4 weeks [Срок оценки: baseline and week 4]
- Change in the Clinical Impairment Assessment (CIA) [Срок оценки: baseline and week 4]
- Change in the Eating Disorder Examination (EDE-Q) [Срок оценки: baseline and week 4]
- Change the Center for Epidemiological Studies Depression Scale (CESD) [Срок оценки: baseline and week 4]
- Change the Anxiety Sensitivity Index (ASI) [Срок оценки: baseline and week 4]
- Change in the Visceral Sensitivity Index (VSI) [Срок оценки: baseline and week 4]
- Change in hunger using a Visual Analogue Scale (VAS) [Срок оценки: baseline and 4 weeks]
- Change in fullness using a Visual Analogue Scale (VAS) [Срок оценки: baseline and 4 weeks]
- Change in sickness using a Visual Analogue Scale (VAS) [Срок оценки: baseline and 4 weeks]
Критерии участия
Критерии включения
- Ages 14-22
- Engaged in standardized refeeding in the EWDP during the intervention (may include individuals with anorexia nervosa or avoidant/restrictive food intake disorder)
- Needing to gain at least 8 lbs during the refeeding period
- English-speaking
Критерии исключения
- Pregnancy
- GI disturbance or diagnosis (Crohn's disease, diverticulitis, irritable bowel syndrome, gastric bezoar, or suspected or known GI obstruction)
- GI surgery in the last 3 months
- Implanted or portable electro-mechanical device such as a pacemaker, defibrillator, or infusion pump
- Allergies to the ingredients in the shake provided
- Use of illicit substances including misuse, overuse, abuse, illegal use, or addiction to or dependence on
- Acute suicide risk/active suicidal ideation determined with the C-SSRS. "Yes" to questions 1 or 2 in the Suicidal Ideation section or "Yes" to any question in the Suicidal Behavior section will be exclusionary
- Psychiatric diagnoses of schizophrenia or bipolar disorder
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- Department of Psychiatry, Eating and Weight Disorders Program — New York
Публикации
- Andersson P, Jamshidi E, Ekman CJ, Tedroff K, Bjorkander J, Sjogren M, Lundberg J, Jokinen J, Desai Bostrom AE. Anorexia Nervosa With Comorbid Severe Depression: A Systematic Scoping Review of Brain Stimulation Treatments. J ECT. 2023 Dec 1;39(4):227-234. doi: 10.1097/YCT.0000000000000922. Epub 2023 Apr 14. PMID 37053429
Идентификаторы
NCT: NCT05554172 · STUDY-21-01790