F10
Conditions
Interventions
Group 1: Evaluation of the effectiveness of the qualified withdrawal therapy program (dt. qualifizierte Entgiftung
QE) established in the clinic followed by a 2-week (10 weekday sessions) intervention with repetitive transcranial magnetic stimulation (rTMS) with specific consideration and characterization of impul
Sponsors
Uniklinik RWTH Aachen; Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Alcohol addiction disorder according to ICD-10 - AUDIT (Alcohol Use Disorders Identification Test) score >15
Exclusion criteria
Exclusion criteria: – Presence of acute suicidal behaviour or acute danger to others – Positive drug screening for illegal drugs (except cannabis) on admission (permitted on admission for inpatient treatment) – Presence of a relevant internal or neurological illness that could result in changes in cognition or personality traits – Limited or complete legal incapacity – Presence of a psychosis from the schizophrenic spectrum The following exclusion criteria apply to rTMS: – Diagnosis of genuine epilepsy or other confounding severe or unstable physical illness, dementia or cognitive impairment and history of traumatic brain injury – Existing pregnancy and breastfeeding – Presence of electromagnetically influenced or metal-containing medical devices in or permanently connected to the body (e.g. pacemakers, drug pumps, cochlear implants) – Previous operations on the heart and/or brain – Previous treatment with rTMS within the last 2 years – If metal parts are present in the body (e.g. screws after bone fracture, metal splinters, metal prostheses), TMS eligibility must be checked on a case-by-case basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcomes are assessed at following timepoints: - Admission visit - V0 after physical detoxification (3rd day after the last administration of diazepam or clomethiazole) - V1 shortly before discharge (after the rTMS intervention; day 15 after the 1st rTMS session) - Follow-up visits 2/3 after 4/12 weeks after discharge 1. Abstinence parameter (visit 2/3) A Timeline-Follow-Back (TLFB) survey is used to determine the following main outcomes with regard to alcohol consumption: - Drinking-free days per time unit - Time until the first drink - Cumulative amount drunk (measured in standard drinks/time unit according to TLFB) - Number of days with more than 3 standard drinks/day 2. Aggression parameters (Viste 0) As part of the provocation paradigm (Point Subtraction Aggression Paradigm Variant I [reactive] / Variant II [proactive]), the relative proportions of aggressive monetary deductions from an opponent are calculated as an index of aggressive behavior. 3. biological parameters (admission visit, V0, V1) - BDNF in peripheral venous blood - Respiratory parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are: - Personality ratings and neuropsychological test parameters; recorded at V0 - Laboratory chemistry (transaminases, cholinesterase, ethyl glucuronide) and CDT (carbodeficient transferrin); recorded at the time of the admission visit, V0, V1 | — |
Countries
Germany
Contacts
Public ContactJana Hovancáková
Uniklinik RWTH Aachen; Klinik für Psychiatrie, Psychotherapie und Psychosomatik
Outcome results
None listed