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Deep Brain Stimulation in Patients with Chronic Treatment Refractory Anorexia Nervosa: a Pilot Study

Completed
Conditions
Anorexia nervosa
self starvation
eating disorder
10003018
10014067
10009720
Registration Number
NL-OMON47057
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
4
Inclusion Criteria

Inclusion criteria studypopulation:
• Primary diagnosis: Anorexia Nervosa (restricting or purging type; 307.1) according to the DSM-IV criteria based on a psychiatric interview
• Chronicity, defined by an illness duration > 10 years
• Disabling severity with substantial functional impairment according to the DSM-IV criterion C and a Global Assessment of Function (GAF) score of 45 or less for at least two years
• Treatment refractoriness, defined as lack of response to two or more typical modes of treatment , including one hospital admission or inpatient treatment in a specialized clinic, as described in the Multidisciplinaire Richtlijn Eetstoornissen (Trimbosinstituut 2008).
• BMI < 15 (level of severity acoording to the DSM 5: extreme)
• Age: 25-65 years old
• Written informed consent
• Dutch or English speaking and able to answer the study questions
• Able to fully understand the consequences of the procedure
• Capable to make his or her own choice without coercion ;Inclusion criteria healthy controlgroup EEG-substudy:
1. Female
2. 25-50 years
3. Matched intelligence level (NLV/DART)
4. Healthy BMI (18.5-25)

Exclusion Criteria

Exclusion criteria studypopulation:
• Unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical contraindications for surgery/anesthesia). The use of anticoagulants must be able to be stopped before surgery
• Treatable underlying cause of anorexia/underweight
• Active neurological disease like Parkinson*s disease, dementia, epilepsy
• Schizophrenia/history of psychosis, bipolar disorder
• Alcohol or substance abuse (including benzodiazepines) during last 6 months
• Current Tic disorder
• Antisocial personality disorder
• Standard MRI scan exclusion criteria (pregnancy, pacemaker and metals contraindicated for MRI);Exclusion criteria healthy control group EEG-substudy:
1. (History of) eating disorders
2. (History of) psychiatric disorders
3. Relevant somatic/neurological disorders
4. Use of psychoactive drugs/substances

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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