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High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation

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ClinicalTrials.gov Identifier: NCT00284219
Recruitment Status : Completed
First Posted : January 31, 2006
Last Update Posted : June 30, 2011
Sponsor:
Information provided by:
Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE January 30, 2006
First Posted Date  ICMJE January 31, 2006
Last Update Posted Date June 30, 2011
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2011)
number of cigarettes smoked
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-Frequency Repetitive Transcranial Magnetic Stimulation Assists In Smoking Cessation
Official Title  ICMJE Not Provided
Brief Summary

Cigarette smoking is a major public health problem causing significant morbidity and mortality. Yet, smoking cessation therapies are often ineffective at helping smokers break their addiction.

The mesolimbic dopaminergic reward system plays a crucial role in mediating the reinforcing effects of nicotine. Recently, acute high frequency repetitive transcranial magnetic stimulation (rTMS) of frontal brain regions has been shown to efficiently modulate the mesolimbic dopamine systems in both animals and humans. For this reason, we investigated whether 10 high-frequency (10Hz) rTMS treatments over the left dorsolateral prefrontal cortex can help people to withdraw smoking in comparison to placebo rTMS.

Smokers seeking to quit are recruited through newspaper advertisements. Participants were randomized to 10 days of either real or placebo high frequency rTMS.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heavy Smoking
Intervention  ICMJE
  • Device: Transcranial Magnetic Stimulation 10Hz
    3. rTMS subjects will receive 20 trains of rTMS at a rate of 10 Hz for 6 seconds (1200 pulses/session). Pulses will be administered over the left dorsolateral prefrontal cortex, defined as 5 cm anterior and in a parasagital plane to the point of maximum stimulation of the abductor pollicis muscle. Pulse intensity will be set at 100% motor threshold.
  • Device: Magnetic stimulation using a special sham coil
    Sham stimulation will be given at the same location as the active, with special sham coil.
Study Arms  ICMJE
  • Active Comparator: Real high frequency rTMS
    The patients will undergo a series of treatments of high frequency rTMS
    Intervention: Device: Transcranial Magnetic Stimulation 10Hz
  • Sham Comparator: Sham high frequency rTMS
    The patients will receive a series of sham treatments.
    Intervention: Device: Magnetic stimulation using a special sham coil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 30, 2006)
50
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:Smoking over 20 Cig a day -

Exclusion Criteria:epilepsy, psychiatry history

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00284219
Other Study ID Numbers  ICMJE SHEBA-04-3401-RA-CTIL
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Revital Amiaz, MD - Senior psychiatrist, Sheba Medical Center
Study Sponsor  ICMJE Sheba Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Revital A Amiaz, MD Sheba Medical Center
Study Director: Abraham Zangen, Phd Weizmann Institute of Science
PRS Account Sheba Medical Center
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP