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Transcranial Magnetic Stimulation in the Treatment of Addiction (MAGENTA)

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ClinicalTrials.gov Identifier: NCT01973127
Recruitment Status : Unknown
Verified October 2013 by IrisZorg.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2013
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
IrisZorg

Brief Summary:

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.

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.


Condition or disease Intervention/treatment Phase
Alcohol Addiction Other: Verum rTMS Other: Sham rTMS Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.
Study Start Date : May 2014
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: 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.

Other: 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 Comparator: 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.

Other: 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.




Primary Outcome Measures :
  1. 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 Measures :
  1. The change from baseline on the amplitude of the LPP at 2 weeks [ Time Frame: 2 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 2 weeks after start of treatment (baseline measurement).

  2. The change from baseline on the amplitude of the LPP at 4 weeks [ Time Frame: 4 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 4 weeks after start of treatment (baseline measurement).

  3. The change from baseline on the amplitude of the LPP at 12 weeks [ Time Frame: 12 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 12 weeks after start of treatment (baseline measurement).

  4. The change from baseline on the amplitude of the ERN at 2 weeks [ Time Frame: 2 weeks after start of treatment ]
    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).

  5. The change from baseline on the amplitude of the ERN at 4 weeks [ Time Frame: 4 weeks after start of treatment ]
    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).

  6. The change from baseline on the amplitude of the ERN 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 Error Related Negativity (ERN) as measured with EEG at 8 weeks after start of treatment (baseline measurement).

  7. The change from baseline on the amplitude of the ERN at 12 weeks [ Time Frame: 12 weeks after start of treatment ]
    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).

  8. Change from baseline on SST at 2 weeks [ Time Frame: at 2 weeks after start treatement ]
    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.

  9. Change from baseline on SST at 4 weeks [ Time Frame: at 4 weeks after start treatement ]
    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.

  10. Change from baseline on SST at 8 weeks [ Time Frame: at 8 weeks after start treatement ]
    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.

  11. Change from baseline on SST at 12 weeks [ Time Frame: at 12 weeks after start treatement ]
    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.

  12. Change from baseline on CCT at 2 weeks [ Time Frame: at 2 weeks after start treatement ]
    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.

  13. Change from baseline on CCT at 4 weeks [ Time Frame: at 4 weeks after start treatement ]
    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.

  14. Change from baseline on CCT at 8 weeks [ Time Frame: at 8 weeks after start treatement ]
    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.

  15. Change from baseline on CCT at 12 weeks [ Time Frame: at 12 weeks after start treatement ]
    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.

  16. Change from baseline on AAAT at 2 weeks [ Time Frame: at 2 weeks after start treatement ]
    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.

  17. Change from baseline on AAAT at 4 weeks [ Time Frame: at 4 weeks after start treatement ]
    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.

  18. Change from baseline on AAAT at 8 weeks [ Time Frame: at 8 weeks after start treatement ]
    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.

  19. Change from baseline on AAAT at 12 weeks [ Time Frame: at 12 weeks after start treatement ]
    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.

  20. Change form baseline on craving at 2 weeks after start treatment [ Time Frame: at 2 weeks after start treatment ]
    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).

  21. Change form baseline on craving at 4 weeks after start treatment [ Time Frame: at 4 weeks after start treatment ]
    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).

  22. Change form baseline on craving at 8 weeks after start treatment [ Time Frame: at 8 weeks after start treatment ]
    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).

  23. Change form baseline on craving at 12 weeks after start treatment [ Time Frame: at 12 weeks after start treatment ]
    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).

  24. Change form baseline on alcohol use at 2 weeks after start treatment [ Time Frame: at 2 weeks after start treatment ]
    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.

  25. Change form baseline on alcohol use at 4 weeks after start treatment [ Time Frame: at 4 weeks after start treatment ]
    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.

  26. Change form baseline on alcohol use at 12 weeks after start treatment [ Time Frame: at 8 weeks after start treatment ]
    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.



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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973127


Contacts
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Contact: Maarten Belgers, MD +31-88-606- 1600 m.belgers@iriszorg.nl
Contact: Ant Schellekens, MD, PhD

Locations
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Netherlands
IrisZorg Not yet recruiting
Nijmegen, Gelderland, Netherlands
Principal Investigator: Maarten Belgers, MD         
Sponsors and Collaborators
IrisZorg
Investigators
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Principal Investigator: Maarten Belgers, MD IrisZorg

Additional Information:
Publications:
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Responsible Party: IrisZorg
ClinicalTrials.gov Identifier: NCT01973127     History of Changes
Other Study ID Numbers: NISPA-IZ/MB22
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by IrisZorg:
alcohol
addiction
TMS
craving
use
rTMS
EEG
LPP
p300
ERN
SST
CCT
AAAT

Additional relevant MeSH terms:
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Behavior, Addictive
Alcoholism
Compulsive Behavior
Impulsive Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs