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 usin
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment effects will be established using within-subject analyses comparing baseline characteristics (T-1 and T0) with patient reports during the optimization phase (T1 and T2) and after 6 months of the maintenance treatment period (T3) and at the end of the maintenance period (T4). Primary outcome measurements are: 1. Physical outcome: Weight improvement/BMI Clinical relevant improvement is defined as relative improvement of BMI of at least 30% compared to the pre-operative BMI or by normalisation of BMI, i.e. reaching a BMI of >= 18 (defined by consensus by D.D., A.E., J.S., M.O.) 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) Clinical relevant improvement is defined as a reduction in pre-operative YBC-EDS scores of al least 35% ánd a CGI-I score of 1 or 2. 3. Quality of life: Score on the EDQOL (Eating Disorders Quality of Life; Engel e.a. 2006) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measurements (assessed at T-1 (pre surgery), T1 (1 month after surgery), T2 (optimization phase), T3 (6 months maintenance phase) and T4 (end of maintenance phase) 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 Questionnaire (EDE-Q; Dutch translation by Jansen 2000), and the Nederlandse Vragenlijst voor Eetgedrag (NVE; van Strien e.a. 1986) c. Assessment of body image disturbance (implicit level) with the Tactile Estimation Task (TET; Keizer e.a. in prep, Keizer e.a. 2012, Keizer e.a. 2011) 2. Quality of life: Secondary outcomes include social function and quality of life using the EQ-5?6D (Euroqol 6 Dimension), the WHO-QOL BREF (World Health Organisation - Quality of Life), the MOS SF12?36 (Medical Outcome Study Short Form), the SDS (Sheehan Disability Scale), and the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire). Additionaly, in order to study the functional efficacy of capsula interna Deep Brain Stimulation in patients with anorexia nervosa, the following studies will be performed: 1) effects of DBS on cerebral perfusion in response to specific tasks using functional MRI 2) electrophysiologic assessment measured through electro-encepahlography (EEG) 3) changes in neuropsychological functioning | — |
Countries
Netherlands
Outcome results
None listed