chronic alcohol dependence F10.2
Conditions
Interventions
Group 1: Implantation of the stimulation electrode
Intervention phase:
12 weeks with activated stimulation electrode
12 weeks with switched off stimulation electrode
From week 25 permanent activatio
Sponsors
Otto-von-Guericke-Universität MagdeburgMedizinische Fakultät, Klinik für Stereotaktie
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Alcoholabusus ICD-10 and DSM-IV 2 Male and female individuals 18-65 years of age 3. No alcohol at least 10 days after completion of detoxification 4 Since 4 weeks no sedative drugs (benzodiazepines, clomethiazole) 5. Therapies without lasting success: including medical detoxification, inpatient or partial inpatient long-term treatment = 8 weeks psychotherapies 6. Relapse prevention medication (acamprosate, naltrexone, disulfiram or other) 7. Therapies must be documented 8. in last 12 months about 6 months "drinking days" 9. Patients are mentally competent, willing and able to sign 10. Patients must have sufficient knowledge of German
Exclusion criteria
Exclusion criteria: 1. medical history cerebral seizures except by alcohol withdrawal 2. severe neurological or internal medical comorbidity 3. coagulopathy 4. other acute, severe, requiring treatment psychiatric disorders of Axis I (according to criteria of DSM IV) 5. personality disorder according SCID-II 6. cardiac or pulmonary disease with risk of anesthesia (ASA value> 3) 7. participation in other clinical studies 30 days before inclusion 8. medical history of significant brain vascular malformations, head injury or neurosurgical operations 9. cerebral changes in current CT / MRI 10. pacemaker or an implantable defibrillator 11. possible need an MRI scan after inclusion in the study 12. pregnancy or lactation or women wishing to become pregnant 13. planned inpatient or partial inpatient long-term therapy 14. mental retardation (HAWIE IQ <70) 15. legal care or patient of a psychiatric facility 16. medical history drug use (current drug abuse) or drug addiction (past drug dependence) - except nicotine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: relapse of alcohol abuse (patient interviews) first evaluation 12 weeks after activation: new evaluation; after conversion of the stimulation 24 weeks after activated stimulation: new evaluation 1 year after activated stimulation: new evaluation 2 years after activated stimulation: new evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: Improvement of cognitive memory function What are the effects of stimulation in the nucleus accumbens on motivational and cognitive processes of patients with chronic alcohol dependence? implementation of following tests: Psychometric testing 3 , 6 and 12 months after implantation : • VLMT - Verbal Learning Test ( using different parallel forms ) • D2 - concentration test • sense memory ( retell stories parallel form ) • I STAI - State Trait Anxiety Inventory (State ) • BDI II - Beck Depression Inventory • LDH - Lifetime Drinking History • SVF - coping questionnaire • I-SEE- Inventory for the Measurement of Self-Efficacy and Externality• Urica - University of Rhode Island Change Assessment ( questionnaire for the assessment of treatment motivation ) • ADS - Alcohol Dependence Scale • AUQ - Alcohol Urge Questionnaire • Fagerström - Test for Nicotine Dependence • CGI - Clinical Global Impression • OCDS - Obsessive Compulsive Drinking Scale • ACQ - Alcohol Craving Questionnaire In addition, the 12 - month follow-up : • SCID- II - Structured Clinical Interview for DSM - IV • HAWIE - Hamburg - Wechsler Intelligence Test for Adults first evaluation 12 weeks after activation: new evaluation; after conversion of the stimulation 24 weeks after activated stimulation: new evaluation 1 year from activated stimulation: new evaluation 2 years from activated stimulation: new evaluation | — |
Countries
Germany
Contacts
Public ContactMartina Leucke
Klinik für Stereotaktische Neurochirurgie
Outcome results
None listed