Back to results

Transcranial Magnetic Stimulation in the Treatment of Addiction (MAGENTA)

Primary Purpose

Alcohol Addiction

Status

Unknown status

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Verum rTMS

Sham rTMS

About this trial

This is an interventional treatment trial for Alcohol Addiction focused on measuring alcohol, addiction, TMS, craving, use, rTMS, EEG, LPP, p300, ERN, SST, CCT, AAAT

Eligibility Criteria

23 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

IrisZorg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum rTMS

Sham TMS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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).

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).

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).

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).

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).

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

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).

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).

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.

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.

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.

Full Information

NCT ID

NCT01973127

First Posted

October 22, 2013

Last Updated

October 25, 2013

Sponsor

IrisZorg

1. Study Identification

Unique Protocol Identification Number

NCT01973127

Brief Title

Transcranial Magnetic Stimulation in the Treatment of Addiction

Acronym

MAGENTA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Unknown status

Study Start Date

May 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IrisZorg

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Addiction

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Verum rTMS

Arm Type

Experimental

Arm Description

Arm Title

Sham TMS

Arm Type

Sham Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Verum rTMS

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Sham rTMS

Intervention Description

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 Measure Information:

Title

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

Description

Time Frame

8 weeks after start of treatment.

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

2 weeks after start of treatment

Title

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

Description

Time Frame

4 weeks after start of treatment

Title

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

Description

Time Frame

12 weeks after start of treatment

Title

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

Description

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).

Time Frame

2 weeks after start of treatment

Title

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

Description

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).

Time Frame

4 weeks after start of treatment

Title

The change from baseline on the amplitude of the ERN at 8 weeks

Description

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).

Time Frame

8 weeks after start of treatment

Title

The change from baseline on the amplitude of the ERN at 12 weeks

Description

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).

Time Frame

12 weeks after start of treatment

Title

Change from baseline on SST at 2 weeks

Description

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.

Time Frame

at 2 weeks after start treatement

Title

Change from baseline on SST at 4 weeks

Description

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.

Time Frame

at 4 weeks after start treatement

Title

Change from baseline on SST at 8 weeks

Description

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.

Time Frame

at 8 weeks after start treatement

Title

Change from baseline on SST at 12 weeks

Description

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.

Time Frame

at 12 weeks after start treatement

Title

Change from baseline on CCT at 2 weeks

Description

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.

Time Frame

at 2 weeks after start treatement

Title

Change from baseline on CCT at 4 weeks

Description

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.

Time Frame

at 4 weeks after start treatement

Title

Change from baseline on CCT at 8 weeks

Description

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.

Time Frame

at 8 weeks after start treatement

Title

Change from baseline on CCT at 12 weeks

Description

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.

Time Frame

at 12 weeks after start treatement

Title

Change from baseline on AAAT at 2 weeks

Description

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.

Time Frame

at 2 weeks after start treatement

Title

Change from baseline on AAAT at 4 weeks

Description

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.

Time Frame

at 4 weeks after start treatement

Title

Change from baseline on AAAT at 8 weeks

Description

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.

Time Frame

at 8 weeks after start treatement

Title

Change from baseline on AAAT at 12 weeks

Description

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.

Time Frame

at 12 weeks after start treatement

Title

Change form baseline on craving at 2 weeks after start treatment

Description

Time Frame

at 2 weeks after start treatment

Title

Change form baseline on craving at 4 weeks after start treatment

Description

Time Frame

at 4 weeks after start treatment

Title

Change form baseline on craving at 8 weeks after start treatment

Description

Time Frame

at 8 weeks after start treatment

Title

Change form baseline on craving at 12 weeks after start treatment

Description

Time Frame

at 12 weeks after start treatment

Title

Change form baseline on alcohol use at 2 weeks after start treatment

Description

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.

Time Frame

at 2 weeks after start treatment

Title

Change form baseline on alcohol use at 4 weeks after start treatment

Description

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.

Time Frame

at 4 weeks after start treatment

Title

Change form baseline on alcohol use at 12 weeks after start treatment

Description

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.

Time Frame

at 8 weeks after start treatment

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

23 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maarten Belgers, MD

Phone

+31-88-606- 1600

m.belgers@iriszorg.nl

First Name & Middle Initial & Last Name or Official Title & Degree

Ant Schellekens, MD, PhD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maarten Belgers, MD

Organizational Affiliation

IrisZorg

Official's Role

Principal Investigator

Facility Information:

Facility Name

IrisZorg

City

Nijmegen

State/Province

Gelderland

Country

Netherlands

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maarten Belgers, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19914283

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.

Results Reference

background

PubMed Identifier

22200135

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.

Results Reference

background

PubMed Identifier

19183128

Citation

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.

Results Reference

background

Links:

URL

http://www.iriszorg.nl

Description

site of addiction care organisation and sponsor

URL

http://www.umcn.nl

Description

site of university hospital where treatment takes place

URL

http://www.nispa.nl

Description

scientific institute related to the study

Learn more about this trial

Transcranial Magnetic Stimulation in the Treatment of Addiction

We'll reach out to this number within 24 hrs