Gastrointestinal Interoception in Anorexia Nervosa
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Capsule stimulation Participants in this arm will receive gastric stimulation via the Vibrant capsule |
Device: Vibrant capsule
A capsule delivering mechanical vibrations
|
| Placebo Comparator: Placebo stimulation Participants in this arm will receive no gastric stimulation via a placebo capsule |
Device: Vibrant capsule
A capsule delivering mechanical vibrations
|
Outcome Measures
Primary Outcome Measures
- Interoceptive precision [At baseline]
Interoceptive sensory precision
- Interoceptive prior [At baseline]
Interoceptive prior expectaiton
- Learning rate [At baseline]
Interoceptive learning rate
- Evoked response potential [At baseline]
Electroencephalogram (EEG) evoked response amplitude within 700 millisecond period following vibration onset
- Electrogastrogram [At baseline]
Stomach electrogastrogram (EGG) power in bradygastria, normogastria, tachygastria and total power bands
Secondary Outcome Measures
- Normalized A prime [At baseline]
Signal detection accuracy measure
- Illness status [At 1 month, 3 month, and 6 month follow-up]
Relapse, remission, or recovery status
Eligibility Criteria
Criteria
Inclusion Criteria:
HC Inclusion criteria:
-
Body mass index ≥ 18.5. 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.
-
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:
-
Primary clinical diagnosis of anorexia nervosa as defined by Laureate Eating Disorders Program ii. Body mass index ≥ 18.5. 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.
-
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.
-
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
Exclusion Criteria:
HC Exclusion criteria:
-
Current diagnosis of a psychiatric disorder per the MINI International Diagnostic Interview
-
Taking any psychotropic medication
-
Active suicidal ideation with intent or plan
-
Active cutting or skin lacerating behaviors
-
Active purging behaviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
-
Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
-
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)
-
History of complicated/obstructive diverticular disease
-
Clinical evidence of significant gastroparesis
-
Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
-
History of intestinal or colonic obstruction, or suspected intestinal obstruction
-
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
-
History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
-
Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
-
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
-
Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
-
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)
-
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
-
No smartphone/computer or limited access to a smartphone/computer
-
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
-
History of a GI bleed within the last 3 months
-
Pelvic floor dysfunction/defecatory disorder, based on subject history
-
Planning to undergo MRI during study time frame
-
Any known allergy to soybean or beeswax or Calcium Carbonate
-
Bradycardia less than 40 beats per minute
-
Pain Disorder
AN Exclusion criteria:
-
Active suicidal ideation with intent or plan
-
Active cutting or skin lacerating behaviors
-
Active purging behviors (specifically, self-induced vomiting), and/or a history of severe self-induced vomiting
-
Pregnancy as defined by a urine screen during screening, and confirmed during each stimulation visit, and must not be lactating
-
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)
-
History of complicated/obstructive diverticular disease
-
Clinical evidence of significant gastroparesis
-
Diagnosis of mega-rectum or colon, congenital anorectal malformation, or clinically significant rectocele or rectal prolapse
-
History of intestinal or colonic obstruction, or suspected intestinal obstruction
-
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
-
History of Zenker's diverticulum, dysphagia, Barrett's esophagus, esophageal stricture or achalasia, transesophageal fistula, or eosinophilic esophagitis.
-
Clinical evidence (as judged by the investigator) of respiratory, cardiovascular, renal, hepatic, biliary, endocrine, or neurologic disease
-
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
-
Cardiac pacemaker, implantable cardioverter defibrillator, implantable infusion device, or gastric electrical stimulator
-
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)
-
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
-
No smartphone/computer or limited access to a smartphone/computer
-
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
-
History of GI bleed within the last 3 months
-
Pelvic floor dysfunction/defecatory disorder, based on subject history
-
Planning to undergo MRI during study time frame
-
Any known allergy to soybean or beeswax, or Calcium Carbonate
-
Bradycardia less than 40 beats per minute
-
Pain Disorder
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Laureate Institute for Brain Research | Tulsa | Oklahoma | United States | 47136 |
Sponsors and Collaborators
- Laureate Institute for Brain Research, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01MH127225