Transcranial Magnetic Stimulation in the Treatment of Addiction

Alcohol Addiction Clinical Trial

— MAGENTA  

Official title:

Repetitive Transcranial Magnetic Stimulation (rTMS) in Alcohol Dependent Patients: a Mechanistic Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01973127
• Other study ID #: NISPA-IZ/MB22
• Status: Not yet recruiting
• Phase: N/A
• First received: October 22, 2013
• Last updated: October 25, 2013
• Start date: May 2014
• Est. completion date: December 2016

Study information

• Verified date: October 2013
• Source: IrisZorg
• Contact: Maarten Belgers, MD
• Phone: +31-88-606- 1600
• Email: m.belgers[@]iriszorg.nl
• Is FDA regulated: No
• Health authority: Netherlands: De Voedsel en Waren AutoriteitNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 23 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Addiction
• Alcoholism
• Behavior, Addictive

Intervention

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 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.

Locations

Country	Name	City	State
Netherlands	IrisZorg	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
IrisZorg

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from baseline on the amplitude of the LPP at 8 weeks	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).	8 weeks after start of treatment.	No
Secondary	The change from baseline on the amplitude of the LPP at 2 weeks	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 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the LPP at 4 weeks	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).	4 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the LPP at 12 weeks	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).	12 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the ERN at 2 weeks	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).	2 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the ERN at 4 weeks	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).	4 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the ERN at 8 weeks	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).	8 weeks after start of treatment	No
Secondary	The change from baseline on the amplitude of the ERN at 12 weeks	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).	12 weeks after start of treatment	No
Secondary	Change from baseline on SST at 2 weeks	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.	at 2 weeks after start treatement	No
Secondary	Change from baseline on SST at 4 weeks	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.	at 4 weeks after start treatement	No
Secondary	Change from baseline on SST at 8 weeks	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.	at 8 weeks after start treatement	No
Secondary	Change from baseline on SST at 12 weeks	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.	at 12 weeks after start treatement	No
Secondary	Change from baseline on CCT at 2 weeks	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.	at 2 weeks after start treatement	No
Secondary	Change from baseline on CCT at 4 weeks	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.	at 4 weeks after start treatement	No
Secondary	Change from baseline on CCT at 8 weeks	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.	at 8 weeks after start treatement	No
Secondary	Change from baseline on CCT at 12 weeks	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.	at 12 weeks after start treatement	No
Secondary	Change from baseline on AAAT at 2 weeks	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.	at 2 weeks after start treatement	No
Secondary	Change from baseline on AAAT at 4 weeks	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.	at 4 weeks after start treatement	No
Secondary	Change from baseline on AAAT at 8 weeks	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.	at 8 weeks after start treatement	No
Secondary	Change from baseline on AAAT at 12 weeks	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.	at 12 weeks after start treatement	No
Secondary	Change form baseline on craving 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).	at 2 weeks after start treatment	No
Secondary	Change form baseline on craving 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).	at 4 weeks after start treatment	No
Secondary	Change form baseline on craving 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).	at 8 weeks after start treatment	No
Secondary	Change form baseline on craving 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).	at 12 weeks after start treatment	No
Secondary	Change form baseline on alcohol use 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.	at 2 weeks after start treatment	No
Secondary	Change form baseline on alcohol use 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.	at 4 weeks after start treatment	No
Secondary	Change form baseline on alcohol use at 12 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.	at 8 weeks after start treatment	No

External Links

•   scientific institute related to the study
•   site of addiction care organisation and sponsor
•   site of university hospital where treatment takes place