Repeated Low-frequency Transcranial Magnetic Stimulation Reduces Cue-induced Craving: a Randomized, Prospective, Double-blind, Sham-controlled, Cross-over Study

NCT ID: NCT01560351

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-01-31

Brief Summary

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The aim of this study is to evaluate the effect of repeated low-frequency Transcranial Magnetic Stimulation (rTMS) of the right dorsolateral prefrontal cortex, combined with gambling cues, on gambling craving. Participants are pathological gamblers. A single real stimulation and a single shame stimulation are administered in a random order for each participant (cross-over study).

Detailed Description

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Conditions

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Pathological Gambling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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rTMS

Session of repeated low-frequency Transcranial Magnetic Stimulation

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

Two sessions of repeated Transcranial Magnetic Stimulation (real rTMS and sham rTMS) are planned for each participant, at interval of 4 weeks, in a random order.

Placebo

Sessions of sham rTMS

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

Two sessions of repeated Transcranial Magnetic Stimulation (real rTMS and sham rTMS) are planned for each participant, at interval of 4 weeks, in a random order.

Interventions

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rTMS

Two sessions of repeated Transcranial Magnetic Stimulation (real rTMS and sham rTMS) are planned for each participant, at interval of 4 weeks, in a random order.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pathological gambler (DSM-IV criteria)
* Seeking treatment at the University Hospital of Nantes
* Right-handed
* 18-65 years old
* Increase in the intensity (at least 50%) of the gambling craving with gambling cues


* pregnant woman
* no effective contraception
* Substance use disorders (excluding nicotine)
* Benzodiazepine use
* Chronic neurological disease
* History of head injury
* History of neurosurgery
* Cochlear implant or other metal objects in the head
* History of Transcranial Magnetic Stimulation or repeated Transcranial
* Magnetic Stimulation
* Difficult to read or write French

Exclusion Criteria

* Occurrence of side effects (like seizures)
* Psychoactive substance use 12 hours before the rTMS (excluding nicotine)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne SAUVAGET, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

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Nantes

Nantes, , France

Site Status

Countries

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France

Related Links

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http://www.crje.fr

Click here for more information about this study and about excessive gambling

Other Identifiers

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BRD/11/6-M

Identifier Type: -

Identifier Source: org_study_id

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