Status:
COMPLETED
Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation
Lead Sponsor:
BeerYaakov Mental Health Center
Conditions:
Chronic Obstructive Pulmonary Disease
Smoking
Eligibility:
All Genders
21-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Deep transcranial magnetic stimulation (TMS) is currently being evaluated as a treatment option in major depression. It has been shown to be a safe procedure . Deep transcranial magnetic stimulation c...
Detailed Description
Research Plan I. PARTICIPANTS Male and female cigarette smokers who suffer from COPD. From the general population aged 21-70 who wishes to quit smoking and failed to respond to previous anti-smoking ...
Eligibility Criteria
Inclusion
- Male or female patients, Aged 21-70 years.
- Subjects who smoke \>20 cigarettes per day.
- Subjects are diagnosed as suffering from COPD
- Patients who are motivated to quit smoking.
- Patients who failed to respond to all 3 of the following anti-smoking treatments:
- po Bupropion (Zyban/Wellbutrin) or Varenicline (Champix)
- Nicotine patch/ nicotine gum
- CBT (Cognitive behavioral therapy)
Exclusion
- History of a primary major psychiatric or cognitive disorder according to DSM IV.
- 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.
- No neurological co-morbidity.
- No psychiatric co-morbidity.
- No 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00951782
Start Date
October 1 2009
End Date
May 1 2013
Last Update
December 20 2013
Active Locations (1)
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1
Beer-Yaacov MHC
Beer-Yaacov, Ezor Hashfela, Israel, 70350