The main objective of this study is to investigate whether rTMS add-on treatment will improve clinical outcomes in alcohol dependence. The secondary objective will be to answer the question through which mechanism rTMS will improve treatment…
ID
Source
Brief title
Condition
- Other condition
- Personality disorders and disturbances in behaviour
Synonym
Health condition
alcoholverslaving
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- In the clinical trial the main study parameter is self-reported level of
craving as measured by the alcohol urge questionnaire (AUQ).
- In the neurobiological trial the main study parameters are baseline brain
activity patterns during fMRI session in comparison to brain activity patterns
after ten rTMS sessions (within subject comparison). These differences in brain
activity patterns will also be assessed between the sham rTMS stimulation group
and the real rTMS stimulation group.
Secondary outcome
- In the clinical trial the secondary study parameters are relapse into alcohol
dependence, changes in measures of impulsivity and compulsivity and changes in
obsessive and compulsive behaviour. Furthermore changes in neuropsychological
reporting will be used as study parameters.
- In the neurobiological trial the secondary study parameters are correlations
of brain activity patterns with behavioural and neuropsychological
measurements.
Background summary
Traditional treatments for addictive disorders (psychotherapy, medication) are
moderately effective at best and very few novel therapies or compounds are in
the pipeline. However, recent studies on neuromodulation have shown promising
results with a single-administration of high-frequency repetitive Transcranial
Magnetic Stimulation (rTMS) resulting in improved prefrontal functioning and
reduced craving [effect size for active stimulation versus sham stimulation
d=.48; as reviewed in a meta-analysis by our group (Jansen, Daams, Koeter,
Veltman, & Goudriaan, 2013)]. Unfortunately, clinical neuromodulation trials
using a series of neuromodulation sessions are very scarce. We therefore
propose a RCT in alcohol dependent patients focusing on the working mechanism
of rTMS and the add-on clinical effect of rTMS, combined with cognitive
behavioural therapy.
Study objective
The main objective of this study is to investigate whether rTMS add-on
treatment will improve clinical outcomes in alcohol dependence. The secondary
objective will be to answer the question through which mechanism rTMS will
improve treatment outcome in alcohol dependent patients.
Study design
Behavioural outcome measures will be used to test whether rTMS add-on treatment
combined with cognitive behavioural therapy, improves clinical outcomes of
alcohol dependent individuals. Furthermore a subgroup of the participants will
undergo a MR scanning protocol in order to investigate the neurobiological
mechanism by which rTMS functions.
Intervention
One group will receive rTMS treatment, and the other group will receive sham
rTMS treatment.
Study burden and risks
The risk and burden associated with participation can be considered minimal. In
the clinical trial there will be 10 rTMS stimulation sessions on subsequent
workdays, and filling in of several craving questionnaires at multiple time
points. In the neurobiological trial there will be two additional scanning
sessions of approximately 1 hour. Furthermore, in both groups structured
diagnostic interviews for psychiatric disorders and personality questionnaires
will be administered. Minimal risk is associated with participation in this
study.
Meibergdreef 5
Amsterdam 1105AZ
NL
Meibergdreef 5
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
The recruitment of participants will take place as follows. Practitioners at
Jellinek will inform patients about our study and we will give presentations at
Jellinek to inform patients about this study. If somebody is willing to
participate in the study, we will personally visit them at Jellinek and explain
the entire procedure. Furthermore they will receive an information letter by
email to make sure they can read the information again carefully. If they are
still interested in participation they will sign informed consent and we will
perform screening for inclusion and exclusion criteria. Demographics,
psychiatric disorders (MINI), TMS contraindications and MR contraindications
are questioned to make sure that the individual can participate.
If a participant meets any of the exclusion criteria that they are excluded
from participation in this study. , Inclusion criteria
- Men and women.
- Age between 25-65.
- Recent DSM-V diagnosis (mild, moderate and severe) of alcohol abuse (<4
months after detox).
- Currently in treatment (>3 weeks after detox) and will be in treatment during
the entire stimulation period (2 weeks after inclusion).
- Sufficient speaking and understanding of Dutch language.
Exclusion criteria
Exclusion criteria
- A DSM-V diagnosis of schizophrenia or another psychotic disorder, personality
disorder or sleep disorder.
- TMS contraindications: history of epileptic seizures or epilepsy in a first
degree relative, irregular sleep/ wake rhythm.
- MR contraindications (only relevant for the 40 participants who will undergo
MR scanning): metal implants, claustrophobia.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52774.018.15 |