Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by BeerYaakov Mental Health Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
BeerYaakov Mental Health Center
Information provided by:
BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT01154712
First received: June 30, 2010
Last updated: July 12, 2010
Last verified: January 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pathological Gambling |
Device: Real Deep TMS Device: Sham Deep TMS |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Deep Low-Frequency Repetitive Transcranial Magnetic Stimulation for Cessation of Pathological Gambling |
Resource links provided by NLM:
Further study details as provided by BeerYaakov Mental Health Center:
Primary Outcome Measures:
- SOGS (South Oaks Gambling Screen) [ Time Frame: 45 days ] [ Designated as safety issue: No ]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.
- Dannon Ainhold Gambling Scale [ Time Frame: 45 days ] [ Designated as safety issue: No ]A scale for assessment of pathological gambling
- visual analogue scale [ Time Frame: 45 Days ] [ Designated as safety issue: No ]An instrument for assessment of desire to indulge in gambling
Secondary Outcome Measures:
- Hamilton Depression 24 items [ Time Frame: 45 Days ] [ Designated as safety issue: No ]Depression assessment scale
- Hamilton Anxiety scale [ Time Frame: 45 days ] [ Designated as safety issue: No ]Anxiety assessment scale
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: 45 days ] [ Designated as safety issue: No ]A scale for assessment of compulsions and obsessions
- Clinical Global Impression Improvement (CGI-I) [ Time Frame: 45 days ] [ Designated as safety issue: No ]A scale for assessment of global clinical improvement
- Social Adaptational Scale(SAS) [ Time Frame: 45 days ] [ Designated as safety issue: No ]A scale for assessment of Social Adaptation
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Dr. Oded Rosenberg, Beer Ya'acov mental health institue |
| ClinicalTrials.gov Identifier: | NCT01154712 History of Changes |
| Other Study ID Numbers: | 244 |
| Study First Received: | June 30, 2010 |
| Last Updated: | July 12, 2010 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by BeerYaakov Mental Health Center:
|
Gambling Deep TMS addiction Brain stimulation |
Additional relevant MeSH terms:
|
Gambling Impulse Control Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013