Anorexia Nervosa
Conditions
Keywords
Interoception
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.
Interventions
DEVICEVibrant capsule
A capsule delivering mechanical vibrations
Sponsors
Laureate Institute for Brain Research, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
HC Inclusion criteria: 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 AN Inclusion criteria: 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
Exclusion criteria
HC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interoceptive prior | At baseline | Interoceptive prior expectaiton |
| 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 |
| Interoceptive precision | At baseline | Interoceptive sensory precision |
| Learning rate | At baseline | Interoceptive learning rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Illness status | At 1 month, 3 month, and 6 month follow-up | Relapse, remission, or recovery status |
| Normalized A prime | At baseline | Signal detection accuracy measure |
Countries
United States
Contacts
Primary ContactJaimee Bruce, BSN
Backup ContactSahib Khalsa, MD
Outcome results
None listed