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Gastrointestinal Interoception in Anorexia Nervosa

ConditionAnorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age15-40
SponsorLaureate Institute for Brain Research, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibrant capsule

    Device

    A capsule delivering mechanical vibrations

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Capsule stimulationExperimental treatment 1 intervention
Group B: Placebo stimulationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Interoceptive precision

Interoceptive sensory precision

Time frame
At baseline
2

Interoceptive prior

Interoceptive prior expectaiton

Time frame
At baseline
3

Learning rate

Interoceptive learning rate

Time frame
At baseline
4

Evoked response potential

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

Time frame
At baseline

Secondary outcomes

1

Normalized A prime

Signal detection accuracy measure

Time frame
At baseline
2

Illness status

Relapse, remission, or recovery status

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Laureate Institute for Brain Research, Inc.

Lead sponsor

Source ClinicalTrials.gov
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