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Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling

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ClinicalTrials.gov Identifier: NCT01154712
Recruitment Status : Unknown
Verified January 2010 by BeerYaakov Mental Health Center.
Recruitment status was:  Recruiting
First Posted : July 1, 2010
Last Update Posted : July 14, 2010
Sponsor:
Information provided by:
BeerYaakov Mental Health Center

Study Description
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Brief Summary:
Pathological gambling (PG) is characterized by a persistent pattern of continued gambling behavior despite its adverse consequences. PG is a chronic, progressive, male-dominated disorder, which has a prevalence of 1% to 3.4% among US adults. Deep transcranial magnetic stimulation (TMS) is a novel neuro-stimulation method capable of inhibiting neuronal activity when given in low frequency. The hypothesis of this study is that , Pathological gambling will be ameliorated if low frequency magnetic field using Brainsway H1 coil will be applied to the left dorso-lateral prefrontal cortex of these patients.

Condition or disease Intervention/treatment Phase
Pathological Gambling Device: Real Deep TMS Device: Sham Deep TMS Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling
Study Start Date : June 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Real Deep TMS
Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions
 Device: Real Deep TMS
Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions
Sham Comparator: Sham Deep TMS
Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions
 Device: Sham Deep TMS
Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions


Outcome Measures
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Primary Outcome Measures :
  1. SOGS (South Oaks Gambling Screen) [ Time Frame: 45 days ]
    The South Oaks Gambling Screen is a 20-item questionnaire based on Diagnostic and Statistical Manual of Mental Disorders, Third Edition (DSM-III) criteria for pathological gambling.

  2. Dannon Ainhold Gambling Scale [ Time Frame: 45 days ]
    A scale for assessment of pathological gambling

  3. visual analogue scale [ Time Frame: 45 Days ]
    An instrument for assessment of desire to indulge in gambling


Secondary Outcome Measures :
  1. Hamilton Depression 24 items [ Time Frame: 45 Days ]
    Depression assessment scale

  2. Hamilton Anxiety scale [ Time Frame: 45 days ]
    Anxiety assessment scale

  3. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 45 days ]
    A scale for assessment of compulsions and obsessions

  4. Clinical Global Impression Improvement (CGI-I) [ Time Frame: 45 days ]
    A scale for assessment of global clinical improvement

  5. Social Adaptational Scale(SAS) [ Time Frame: 45 days ]
    A scale for assessment of Social Adaptation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathological gambling according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)

Exclusion Criteria:

  • History of a primary major psychiatric or cognitive disorder according to DSM IV apart from Pathological gambling.
  • Current alcohol or other substance abuse or dependence.
  • Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
  • History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery.
  • Significant neurological co-morbidity.
  • psychiatric co-morbidity.
  • psychotropic medications.
  • Severe somatic co morbidity.
  • Cardiac pace makers, other electronic implants, intracranial metallic particles.
  • History of seizures or epileptiform activity.
  • Pregnancy and lactation.
  • Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
  • Patients unwilling or unable to give written informed consent.
  • Patients with a high risk for severe violence or suicidality as assessed during the screening interview.
  • Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154712


Contacts
Contact: Oded Rosenberg, M.D. 97289284293 odedaruna@gmail.com
Contact: Pinhas Dannon, M.D. 97289258396 pinhas.dannon@beerness.health.gov.il

Locations
Israel
Beer Yaakov Mental Health Center Recruiting
Beer Yaakov, Hashfela, Israel, 70350
Contact: Oded Rosenberg, MD    97289284293    odedaruna@gmail.com   
Contact: Pinhas Dannon, MD    97289258396    pinhas.dannon@beerness.health.gov.il   
Sponsors and Collaborators
BeerYaakov Mental Health Center
Investigators
Study Chair: Oded Rosenberg, MD Beer Yaakov Mental Health Center
Principal Investigator: Pinhas Dannon, MD Beer Yaakov Mental Health Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Oded Rosenberg, Beer Ya'acov mental health institue
ClinicalTrials.gov Identifier: NCT01154712     History of Changes
Other Study ID Numbers: 244
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: January 2010

Keywords provided by BeerYaakov Mental Health Center:
Gambling
Deep TMS
addiction
Brain stimulation

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders