Gastrointestinal Interoception in Anorexia Nervosa

NCT05111977 | Recruiting FDA Device

• 1 other identifier: R01MH127225
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia Nervosa

Keywords

Interoception

Outcome Measures

Primary Outcomes (5)

• Interoceptive precision

  Interoceptive sensory precision

  At baseline

• Interoceptive prior

  Interoceptive prior expectaiton

  At baseline

• Learning rate

  Interoceptive learning rate

  At baseline

• Evoked response potential

  Electroencephalogram (EEG) evoked response amplitude within 700 millisecond period following vibration onset

  At baseline

• Electrogastrogram

  Stomach electrogastrogram (EGG) power in bradygastria, normogastria, tachygastria and total power bands

  At baseline

Secondary Outcomes (2)

• Normalized A prime

  At baseline

• Illness status

  At 1 month, 3 month, and 6 month follow-up

Study Arms (2)

Capsule stimulation

EXPERIMENTAL

Participants in this arm will receive gastric stimulation via the Vibrant capsule

Device: Vibrant capsule

Placebo stimulation

PLACEBO COMPARATOR

Participants in this arm will receive no gastric stimulation via a placebo capsule

Device: Vibrant capsule

Interventions

Vibrant capsule DEVICE

A capsule delivering mechanical vibrations

Capsule stimulation; Placebo stimulation

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• i. 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.
• 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
• i. 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laureate Institute for Brain Research, Inc.: lead

Study Sites (1)

Laureate Institute for Brain Research

Tulsa, Oklahoma, 47136, United States

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Central Study Contacts

Jaimee Bruce, BSN

CONTACT

9185025145; JBruce@laureateinstitute.org

Sahib Khalsa, MD

CONTACT

9185025743; skhalsa@laureateinstitute.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 8, 2021
• Study Start: December 1, 2021
• Primary Completion: April 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available approximately one year after the end of the study period.

Locations

US (1)