NCT01154712

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 14, 2010

Status Verified

January 1, 2010

Enrollment Period

2 years

First QC Date

June 30, 2010

Last Update Submit

July 12, 2010

Conditions

Pathological Gambling

Keywords

GamblingDeep TMSaddictionBrain stimulation

Outcome Measures

Primary Outcomes (3)

  • SOGS (South Oaks Gambling Screen)

    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.

    45 days

  • Dannon Ainhold Gambling Scale

    A scale for assessment of pathological gambling

    45 days

  • visual analogue scale

    An instrument for assessment of desire to indulge in gambling

    45 Days

Secondary Outcomes (5)

  • Hamilton Depression 24 items

    45 Days

  • Hamilton Anxiety scale

    45 days

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    45 days

  • Clinical Global Impression Improvement (CGI-I)

    45 days

  • Social Adaptational Scale(SAS)

    45 days

Study Arms (2)

Real Deep TMS

ACTIVE COMPARATOR

Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions

Device: Real Deep TMS

Sham Deep TMS

SHAM COMPARATOR

Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions

Device: Sham Deep TMS

Interventions

Real Deep TMSDEVICE

Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions

Real Deep TMS
Sham Deep TMSDEVICE

Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions

Sham Deep TMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beer Yaakov Mental Health Center

Beer Yaakov, Hashfela, 70350, Israel

RECRUITING

MeSH Terms

Conditions

GamblingBehavior, Addictive

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersCompulsive BehaviorImpulsive Behavior

Study Officials

  • Oded Rosenberg, MD

    Beer Yaakov Mental Health Center

    STUDY CHAIR

  • Pinhas Dannon, MD

    Beer Yaakov Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oded Rosenberg, M.D.

CONTACT

97289284293odedaruna@gmail.com

Pinhas Dannon, M.D.

CONTACT

97289258396pinhas.dannon@beerness.health.gov.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 30, 2010

First Posted

July 1, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 14, 2010

Record last verified: 2010-01

Locations

IL(1)