Transcranial Magnetic Stimulation in the Treatment of Addiction

NCT01973127 | Unknown

• 1 other identifier: NISPA-IZ/MB22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Addiction

Keywords

alcohol; addiction; TMS; craving; use; rTMS; EEG; LPP; p300; ERN; SST; CCT; AAAT

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (26)

• The change from baseline on the amplitude of the LPP at 2 weeks

  2 weeks after start of treatment

• The change from baseline on the amplitude of the LPP at 4 weeks

  4 weeks after start of treatment

• The change from baseline on the amplitude of the LPP at 12 weeks

  12 weeks after start of treatment

• The change from baseline on the amplitude of the ERN at 2 weeks

  2 weeks after start of treatment

• The change from baseline on the amplitude of the ERN at 4 weeks

  4 weeks after start of treatment

Study Arms (2)

Verum rTMS

EXPERIMENTAL

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

Sham TMS

SHAM COMPARATOR

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

Interventions

Verum rTMS OTHER

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.

Verum rTMS

Sham rTMS OTHER

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.

Sham TMS

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IrisZorg: lead

Study Sites (1)

IrisZorg

Nijmegen, Gelderland, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 19914283 BACKGROUND

• 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.

  PMID: 22200135 BACKGROUND

• 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.

  PMID: 19183128 BACKGROUND

• Belgers M, Markus W, Grasso F, Arns M, Van Eijndhoven P, Schellekens A. No Effects of rTMS on Performance Monitoring and Attentional Bias in Patients With Alcohol Use Disorder: A Pilot Study. Addict Biol. 2025 Nov;30(11):e70100. doi: 10.1111/adb.70100.

  PMID: 41253702 DERIVED

Related Links

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

MeSH Terms

Conditions

Alcoholism; Behavior, Addictive

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• Maarten Belgers, MD

  IrisZorg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maarten Belgers, MD

CONTACT

+31-88-606- 1600; m.belgers@iriszorg.nl

Ant Schellekens, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2013
• First Posted: October 31, 2013
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2016
• Last Updated: October 31, 2013

Record last verified: 2013-10

Locations

NL (1)