The investigators hypothesize that repetitive transcranial magnetic stimulation (rTMS) on the right side of the head will make craving towards alcohol less severe in recently detoxified alcohol addicted patients.In this study the investigators focus…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
afhankelijkheid van alcohol
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change from baseline on the amplitude of the LPP at 8 weeks. Time Frame: 8
weeks after start of treatment.
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured
with EEG at 8 weeks after start of treatment (baseline measurement).
Secondary outcome
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured
with EEG at 2 weeks after start of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured
with EEG at 4 weeks after start of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Late Positive Potentials (LPP) (P300 and Slow Potential (SP)) as measured
with EEG at 12 weeks after start of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Error Related Negativity (ERN) as measured with EEG at 2 weeks after start
of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Error Related Negativity (ERN) as measured with EEG at 4 weeks after start
of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Error Related Negativity (ERN) as measured with EEG at 8 weeks after start
of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in amplitude of
the Error Related Negativity (ERN) as measured with EEG at 12 weeks after start
of treatment (baseline measurement).
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 2 weeks follow-up, by conducting a Stop-Signal Task (SST)per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 4 weeks follow-up, by conducting a Stop-Signal Task (SST)per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 12 weeks follow-up, by conducting a Stop-Signal Task (SST) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 12 weeks follow-up, by conducting a Stop-Signal Task (SST) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 2 weeks follow-up, by conducting a Columbia Card Task (CCT) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 4 weeks follow-up, by conducting a Columbia Card Task (CCT) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 8 weeks follow-up, by conducting a Columbia Card Task (CCT) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 12 weeks follow-up, by conducting a Columbia Card Task (CCT) per
computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 2 weeks follow-up, by conducting a Alcohol Approach Avoidance
Task (AAAT) per computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 4 weeks follow-up, by conducting a Alcohol Approach Avoidance
Task (AAAT) per computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 8 weeks follow-up, by conducting a Alcohol Approach Avoidance
Task (AAAT) per computer.
To investigate the effect of 20 sessions of rTMS on the change in cognitive
performance at 12 weeks follow-up, by conducting a Alcohol Approach Avoidance
Task (AAAT) per computer.
To investigate the change of 20 sessions of rTMS in perceived patient reported
craving at 2 weeks after start treatment as measured with the Obsessive
Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a
craving Visual Analogue Scale (VAS).
To investigate the change of 20 sessions of rTMS in perceived patient reported
craving at 4 weeks after start treatment as measured with the Obsessive
Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a
craving Visual Analogue Scale (VAS).
To investigate the change of 20 sessions of rTMS in perceived patient reported
craving at 8 weeks after start treatment as measured with the Obsessive
Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a
craving Visual Analogue Scale (VAS).
To investigate the change of 20 sessions of rTMS in perceived patient reported
craving at 12 weeks after start treatment as measured with the Obsessive
Compulsing Drinking Scale (OCDS), Alcohol Urge Questionnaire (AUQ) and a
craving Visual Analogue Scale (VAS).
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 2
weeks from baseline by filling in a dairy on treatment days 5 times a week.
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 4
weeks from baseline by filling in a dairy on treatment days 5 times a week.
To investigate the effect of 20 sessions of rTMS on the change in alcohol use 8
weeks from baseline by using the Alcohol Timeline Follow Back (TLFB) method.
To investigate the effect of 20 sessions of rTMS on the change in alcohol use
12 weeks from baseline by using the Alcohol Timeline Follow Back (TLFB) method.
Background summary
Although there are successful treatment option to detoxify patients form their
alcohol use, many patients tend to relapse. This relapse is mainly caused by a
high level of (uncontrollable) craving towards alcohol. This aspect of
addiction is with the existing options hard to treat, there is a great need of
new successful treatment modalities. rTMS is a FDA approved treatment method
for depression. Recently some small scale studies have shown promising results
on rTMS in the treatment of addiction. In this study the investigators focus on
alcohol addiction since it is the addiction with the highest morbidity and
mortality in the Netherlands.
Study objective
The investigators hypothesize that repetitive transcranial magnetic stimulation
(rTMS) on the right side of the head will make craving towards alcohol less
severe in recently detoxified alcohol addicted patients.
In this study the investigators focus on three levels of interest: the
biological level, the functional level and the clinical level. The
investigators will measure the effect of rTMS directly on brain activity
through EEG recording. The investigators investigate its effects on cognitive
performance through the use of neuropsychological computer tasks. The
investigators will address clinical behavior (craving and alcohol use) with
questionnaires.
Study design
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
The experimental arm:
n=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will
start : 20 sessions (5 times during 4 weeks)of verum rTMS on the right
dorsolateral prefrontal cortex. Measurements of all objectives at baseline and
2,4,8 and 12 weeks after start treatment.
Intervention:rTMS on the right dorsolateral prefrontal cortex. TMS procedure:
The resting motor threshold (RMT) will be defined in each subject as the
minimal stimulation intensity evoking an MEP of >= 0.05 mV in 50% of the trials
in the muscle of the right thumb (M. abductor pollicis brevis). TMS will be
conducted in the form of 'conventional rTMS', whereby 30 trains of 10 Hz pulses
with a duration of 5 seconds and an inter-train interval of 25 seconds are
applied to the righ dorsolateral prefrontal cortex (50 pulses per train, 6000
pulses per session). Used equipment: Magstim Rapid 2 device.
The placebo arm:
n=15. After detoxification of alcohol (maximum 4 days) rTMS treatment will
start : 20 sessions (5 times during 4 weeks)of sham rTMS on the right
dorsolateral prefrontal cortex. Measurements of all objectives at basleine and
2,4,8 and 12 weeks after start treatment.
TMS procedure: The resting motor threshold (RMT) will be defined in each
subject as the minimal stimulation intensity evoking an MEP of >= 0.05 mV in 50%
of the trials in the muscle of the right thumb (M. abductor pollicis brevis).
Like in verum TMS coil will be placed on the skull, but no magnetic field will
be pulsed. Used equipment: Magstim Rapid 2 device.
Intervention
Verum rTMS or sham-rTMS
TMS procedure: The resting motor threshold (RMT) will be defined in each
subject as the minimal stimulation intensity evoking an MEP of >= 0.05 mV in 50%
of the trials in the muscle of the right thumb (M. abductor pollicis brevis).
TMS will be conducted in the form of 'conventional rTMS', whereby 30 trains of
10 Hz pulses with a duration of 5 seconds and an inter-train interval of 25
seconds are applied to the righ dorsolateral prefrontal cortex (50 pulses per
train, 6000 pulses per session). Used equipment: Magstim Rapid 2 device
Study burden and risks
Burden
In Enrollment-fase: conducting MINI-plus 45 min.
No risks or side-efects.
Burden during treatment: over the course of four weeks 20 sessions of 30
minutes rTMS, while seated in a chair. Risks are minmal: temporarily mild
headache. No risks or side effcets involved in teh use of sham-rTMS.
On treatment days filling in a form on craving and alcohol use: 5 miuntes
During measuremenst:
On baseline and 2-4-8 en 12 weeks:
EEG (30'min), functional measurements (with computer tasks) (30'min),
questionnaire in alcohol use and craving: 15'minutes.
No risks or side-effects.
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Reinier Postlaan 10
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
•Right-handed males between 23-65 years of age
•A primary diagnose of alcohol dependence (meeting the DSM-IV-TR criteria 303.90/ICD-10 F10.2)
•Written consent for participation of the study.
Exclusion criteria
•MATE outcome <4 (as extracted from part 4 MATE at enrollment phase) MATE= Dutch screening instrument on (among others) addiction severity
•Presence of a current or past relevant somatic or neurological disorder
•Meeting the DSM-IV-TR criteria for a current bipolar disorder, schizophrenia, anxiety disorder or moderate to severe depressive disorder. These disorders would be a possible great confounder. Measured with the MINI-plus.
•Meeting the DSM-IV-TR criteria for current (in the past 2 weeks) dependence of substances other than alcohol, nicotine or caffeine. Information present in MATE.
•Participant-bound factors that may endanger participants or may jeopardize study adherence, because of failure to understand and/or comply with instructions (e.g. current, disruptive symptoms such as psychotic symptoms or severe cognitive impairment)
•Contra-indications resulting from the use of rTMS:;*Epilepsy, convulsion or seizure
*Serious head trauma or brain surgery
*Large or ferromagnetic metal parts in the head (except for a dental wire)
*Implanted cardiac pacemaker or neurostimulator
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT01973127 |
| CCMO | NL46974.091.13 |