Anorexia nervosa
Conditions
Interventions
The intervention of this study will be Deep Brain
Stimulation (DBS) in the ventral limb of the capsula
interna. Deep Brain stimulation is an adjustable,
reversible, non-destructive intervention u
Sponsors
Prof. dr. D.A.J.P. Denys
Academic Medical Centre (AMC), department of psychiatry
Eligibility
Inclusion criteria
Inclusion criteria: 1. Primary diagnosis: Anorexia Nervosa (restricting or purging type; 307.1) according to the DSM-IV criteria based on a psychiatric interview; 2. Chronicity, defined by an illness duration > 10 years; 3. 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; 4. 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); 5. BMI < 15 (level of severity according to the DSM V: extreme); 6. Age: 25-65 years old; 7. Written informed consent; 8Dutch or English speaking and able to answer the study questions; 9.Capable to make his or her own choice without coercion.
Exclusion criteria
Exclusion criteria: 1. Unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical contraindications for surgery/anesthesia, unability to stop the use of anticoagulants; 2. Treatable underlying cause of anorexia/underweight; 3. Active neurological disease like Parkinson’s disease, dementia, epilepsy; 4. Schizophrenia/history of psychosis, bipolar disorder; major depressive disorder; 5. Alcohol or substance abuse (including benzodiazepines) during the last 6 months; 6. Current Tic disorder; 7. Antisocial personality disorder; 8. Standard MRI scan exclusion criteria (pregnancy, pacemaker and metals contraindicated for MRI);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effects will be established using within-subject analyses comparing baseline characteristics(T-1) with patient reports during the optimization phase (T1 and T2), and during the maintenance phase (T3 and T4). Primary outcome measurements are: 1. Physical outcome: Weight improvement/BMI; 2. Psychological outcome: Score on the Yale-Brown-Cornell Eating Disorder Scale ( YBC- EDS; Mazure e.a. 1994, Dutch translation by our department with back-translation to ensure conceptual equivalence). 3. Quality of life: Score on the EDQOL (Eating Disorders Quality of Life; Engel e.a. 2006). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measurements include: 1. Additional psychological outcome: a. Eating behaviour measured by assessing the quantity, quality and choice of food; b. Assessment of eating behaviour with the Eating Disorder Inventory (EDI-II; van Strien 2002), the Eating Disorder Examination (EDE; Dutch translation by Jansen 2000), and the Nederlandse Vragenlijst voor Eetgedrag (NVE; van Strien e.a. 1986). 2. Quality of life: Secondary outcomes include social function and quality of life using the EQ-6D (Euroqol 6 Dimension), the WHO-QOL BREF (World Health Organisation – Quality of Life), the MOS SF36 (Medical Outcome Study Short Form), the SDS (Sheehan Disability Scale), and the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire). Additionally, the functional aspects of DBS wil be explored in different ways. In this study, clinical outcome measures will be associated with: 1. Effects of DBS on cerebral perfusion in response to specific tasks using functional MRI; 2. EEG changes 3. Changes in neuropsychological functioning using the CATAB (Cambridge Neuropsychological Test Automated Battery, Elliott e.a. 1998) | — |
Contacts
Public ContactM.S. Oudijn
AMC Afdeling psychiatrie Meibergdreef 5
Outcome results
None listed