NCT05111977招募中不适用
A Neurocomputational Assay of Gastrointestinal Interoception in Anorexia Nervosa
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Interoceptive prior
研究概览
简要总结
Anorexia nervosa (AN) has among the highest mortality rate of any psychiatric illness, yet we have a poor understanding of the biological causes of this disorder. In this study, we use a novel mechanosensory intervention to examine the basic question of whether individuals with AN have abnormal "gut sensations" and whether such indicators are associated with adverse consequences from the disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •HC Inclusion criteria:
- •i. Body mass index ≥ 18.
- •ii. Females, ages 15 to 40 years iii. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
- •iv. Independently ambulatory v. Possession of a smartphone with data plan vi. English proficiency vii. Willingness and ability to participate in study procedures viii. Provision of signed and dated informed consent form
- •AN Inclusion criteria:
- •i. Primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program ii. Body mass index ≥ 18.
- •iii. Transitioned from acute clinical status rating to residential clinical status or partial/intensive outpatient clinical status rating iv. No new medication prescription in the week prior to study randomization, Must be on a stable dose of medication for at least 1 week.
- •v. Females, ages 15 to 40 years vi. Women of childbearing age: a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study.
- •vii. Independently ambulatory viii. Possession of a smartphone with data plan ix. English proficiency x. Willingness and ability to participate in study procedures xi. Provision of signed and dated informed consent form
排除标准
- •HC Exclusion criteria:
- •i. Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
- •ii. Taking any psychotropic medication
- •iii. Active suicidal ideation with intent or plan
- •iv. Active cutting or skin lacerating behaviors
- •v. Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
- •vi. Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
- •vii. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
- •viii. History of complicated/obstructive diverticular disease
- •ix. Clinical evidence of significant gastroparesis
- •x. Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
- •xi. History of intestinal or colonic obstruction, or suspected intestinal obstruction
- •xii. History of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
- •xiii. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
- •xiv. Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
- •xv. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
- •xvi. Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
- •xxv. Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
- •xxvi. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
- •xxvii. No smartphone/computer or limited access to a smartphone/computer
- •xxviii. Regular use of any of the following medications or procedures: Medications that may substantially affect intestinal motility, prokinetics at high doses (metoclopramide, erythromycin, senna, prucalopride), anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, enemas
- •xxix. History of a GI bleed within the last 3 months
- •xxx. Pelvic floor dysfunction/defecatory disorder, based on subject history
- •xxxi. Planning to undergo MRI during study time frame
- •xxxii. Any known allergy to soybean or beeswax or Calcium Carbonate
- •xxxiii. Bradycardia less than 40 beats per minute
- •xxxiv. Pain Disorder
- •AN Exclusion criteria:
- •i. Active suicidal ideation with intent or plan
- •ii. Active cutting or skin lacerating behaviors
- •iii. Active purging behviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
- •iv. Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
- •v. History of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is accepted if the subject has been treated and is in remission)
- •vi. History of complicated/obstructive diverticular disease
- •vii. Clinical evidence of significant gastroparesis
- •viii. Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
- •ix. History of intestinal or colonic obstruction, or suspected intestinal obstruction
- •x. History of intestinal resection (with an exception for appendectomy, cholecystectomy and inguinal hernia repair), history of bariatric surgery or evidence of any structural abnormality of the gastrointestinal tract that might affect transit
- •xi. History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
- •xii. Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
- •xiii. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs): chronic use is defined as taking full dose NSAIDs more than three times a week for at least six months. Subjects on cardiac doses of aspirin may be enrolled in the study
- •xiv. Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
- •xv. Orthostatic hypotension (defined as a drop of ≥ 20 mm Hg in systolic BP or a drop of ≥ 10 mm Hg in diastolic BP when measured shortly after transitioning from lying down to standing)
- •xvi. Any other condition which in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study
- •xvii. No smartphone/computer or limited access to a smartphone/computer
- •xviii. Regular use of any of the following medications or procedures: Medications that may substantially affect intestinal motility, prokinetics at high doses (metoclopramide, erythromycin, senna, prucalopride), anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, enemas
- •xix. History of GI bleed within the last 3 months
- •xx. Pelvic floor dysfunction/defecatory disorder, based on subject history
- •xxi. Planning to undergo MRI during study time frame
- •xxii. Any known allergy to soybean or beeswax, or Calcium Carbonate
- 另有 2 项未显示
结局指标
主要结局
Interoceptive prior
时间窗: At baseline
Interoceptive prior expectaiton
Evoked response potential
时间窗: At baseline
Electroencephalogram (EEG) evoked response amplitude within 700 millisecond period following vibration onset
Electrogastrogram
时间窗: At baseline
Stomach electrogastrogram (EGG) power in bradygastria, normogastria, tachygastria and total power bands
Interoceptive precision
时间窗: At baseline
Interoceptive sensory precision
Learning rate
时间窗: At baseline
Interoceptive learning rate
次要结局
- Illness status(At 1 month, 3 month, and 6 month follow-up)
- Normalized A prime(At baseline)
研究者
研究点 (2)
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