Transcranial Magnetic Stimulation in the Treatment of Addiction
NCT ID: NCT01973127
Last Updated: 2013-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2014-05-31
2016-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Verum rTMS
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.
Verum rTMS
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.
Sham TMS
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.
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). Like in verum TMS coil will be placed on the skull, but no magnetic field will be pulsed. Used equipment: Magstim Rapid 2 device.
Interventions
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Verum rTMS
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.
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). Like in verum TMS coil will be placed on the skull, but no magnetic field will be pulsed. Used equipment: Magstim Rapid 2 device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
23 Years
65 Years
MALE
No
Sponsors
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IrisZorg
OTHER
Responsible Party
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Principal Investigators
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Maarten Belgers, MD
Role: PRINCIPAL_INVESTIGATOR
IrisZorg
Locations
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IrisZorg
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Ant Schellekens, MD, PhD
Role: CONTACT
References
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Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.
Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.
Related Links
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site of addiction care organisation and sponsor
site of university hospital where treatment takes place
scientific institute related to the study
Other Identifiers
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NISPA-IZ/MB22
Identifier Type: -
Identifier Source: org_study_id