Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT03168893
Eligibility Criteria:
Inclusion Criteria:
(All criteria for inclusion must be met)
1. Age between 18-60 years
2. Diagnosis of AN, both restrictive type and compulsion / purge type defined by the DSM-V-TR
3. Chronicity: minimum of 10 years of illness.
4. Resistance to treatment, shown by one or both of the following situations:
A. That of the multiple treatments performed, at least 1 is an intensive treatment (hospitalization or day hospital), with one or more of the following results:
* I have not been able to finish the treatment.
* That it has finished but with little or no answer.
* That in spite of having finished it, and of having answered, Has found a subsequent relapse in the first six months. B. Clinical situation of medical instability, accompanied by refusal to participate in any treatment program and including at least 1 episode of admission for involuntary feeding.
5. Extremely serious (BMI less than 15), or severe (BMI between 15-15,99)
6. Ability to sign informed consent
7. Ability to undergo all tests and follow-ups of the study
Exclusion Criteria:
1. BMI less than 13 at the time of recruitment for the study.
2. Psychosis in the present moment or in the past.
3. Current neurological disease.
4. Substance or alcohol abuse and dependence in the last year.
5. Contraindications to perform a brain MRI
6. Presence of cardiac arrhythmias or other cardiac, respiratory, renal or endocrine affections, as a result of AN or not, that carries risk for the surgical procedure.
7. Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT03168893
Study Brief:
Protocol Section:
NCT03168893