Gastrointestinal Interoception in Anorexia Nervosa

Part of paid clinical trials in Tulsa, Oklahoma.

Sponsor
Laureate Institute for Brain Research, Inc.
Study ID
NCT05111977
Status
Recruiting
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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Vibrant capsule — DEVICE
    A capsule delivering mechanical vibrations

Study Details

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.

Key Dates

Start date
Dec 1, 2021
Status verified
May 2024
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Capsule stimulation
    Participants in this arm will receive gastric stimulation via the Vibrant capsule
  • Placebo Comparator: Placebo stimulation
    Participants in this arm will receive no gastric stimulation via a placebo capsule

Primary Outcome Measure

Interoceptive precision [ Time Frame: At baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Laureate Institute for Brain ResearchTulsaOklahoma47136
Colleen McCallum, MBA
[email protected]
Sahib S Khalsa, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Laureate Institute for Brain Research· Tulsa, OK

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