Transcranial Magnetic Stimulation in the Treatment of Addiction

Not Applicable

• Conditions: Alcohol Addiction
• Interventions: Other: Verum rTMS; Other: Sham rTMS

• Registration Number: NCT01973127
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Last Update Submitted: 2013-10-25
• Study First Posted: 2013-10-31
• Last Update Posted: 2013-10-31
• Study Start: 2014-05
• Primary Completion: 2015-04
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum rTMS	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.
Sham TMS	Sham rTMS	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.

Primary Outcome Measures

Name	Time	Method
The change from baseline on the amplitude of the LPP at 8 weeks	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

Name	Time	Method
Change from baseline on CCT at 2 weeks	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.
Change form baseline on alcohol use at 4 weeks after start treatment	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.
Change form baseline on alcohol use at 12 weeks after start treatment	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.
The change from baseline on the amplitude of the LPP at 2 weeks	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).
The change from baseline on the amplitude of the LPP at 4 weeks	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).
The change from baseline on the amplitude of the LPP at 12 weeks	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).
The change from baseline on the amplitude of the ERN at 2 weeks	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).
The change from baseline on the amplitude of the ERN at 4 weeks	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).
The change from baseline on the amplitude of the ERN at 8 weeks	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).
The change from baseline on the amplitude of the ERN at 12 weeks	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).
Change from baseline on SST at 2 weeks	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.
Change from baseline on SST at 4 weeks	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.
Change from baseline on SST at 8 weeks	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.
Change from baseline on SST at 12 weeks	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.
Change from baseline on CCT at 4 weeks	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.
Change from baseline on CCT at 8 weeks	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.
Change from baseline on CCT at 12 weeks	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.
Change from baseline on AAAT at 2 weeks	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.
Change from baseline on AAAT at 4 weeks	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.
Change from baseline on AAAT at 8 weeks	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.
Change from baseline on AAAT at 12 weeks	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.
Change form baseline on craving at 2 weeks after start treatment	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).
Change form baseline on craving at 4 weeks after start treatment	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).
Change form baseline on craving at 8 weeks after start treatment	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).
Change form baseline on craving at 12 weeks after start treatment	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).
Change form baseline on alcohol use at 2 weeks after start treatment	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.

Trial Locations

Locations (1)

IrisZorg; 🇳🇱 Nijmegen, Gelderland, Netherlands