Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation (TMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pinhas Dannon, BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:
NCT00951782
First received: July 14, 2009
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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 coils are designed to maximize the electrical field deep in the brain by the summation of separate fields projected into the skull from several points around its periphery. The device is planned to minimize the accumulation of electrical charge on the surface of the brain. Such accumulation can give rise to an electrostatic field that might reduce the magnitude of the induced electric field both at the surface and inside, thus reducing the depth penetration of the induced electric field . Deep transcranial magnetic stimulation could be more effective than repetitive transcranial magnetic stimulation due to its deeper penetration into brain tissues . The deeper penetration should produce greater action on nerve fibers connecting the prefrontal cortex to the limbic system.

The ability of high-frequency repetitive transcranial magnetic stimulation (rTMS) to alter dopaminergic neurotransmission in subcortical structures could explain recent reports, which suggest that it has the potential to reduce smoking and nicotine craving. Ecihhammer et al demonstrated a reduction in the number of cigarettes smoked and in the desire to smoke after a single rTMS treatment (Eichhammer et al., 2003). In addition, Johan et al in a cross-over, double-blind, placebo-controlled study demonstrated a reduction in cigarette consumption and desire to smoke after a single repetitive transcranial magnetic stimulation treatment (Johann et al., 2003). Recently, the investigators have finished a complete study on nicotine addiction using repetitive transcranial magnetic stimulation for 10 consecutive days. They have found that 10 days of rTMS reduced significantly better from placebo the number of cigarettes smoked, nicotine dependence and craving (Amiaz et al 2007, in preparation). Interestingly, some of the effects were stronger in the sub-group of patients that were presented with smoking-related pictures immediately prior to stimulation onset. Although, these results are interesting and exciting, they have two important caveats. First, only about 50%-60% of the smokers responded to the repetitive transcranial magnetic stimulation treatment. Second, among those responded to the treatment, only 10% had quit totally from smoking. Therefore, the potential therapeutic benefit of this treatment is limited. The investigators' hypothesis is that deep transcranial magnetic stimulation may be more efficient in smoking cessation due to it's deeper penetration and therefore it's capability to stimulate deeper fibers of the dopamine-reward-activating system.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Smoking
Device: High frequency TMS
Device: Sham TMS
Device: Low frequency TMS
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:
  • Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of treatment (3rd week) [ Time Frame: 3 weeks of treatment (and additional 34 weeks of maintenance & follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of maintenance & follow-up(37th week) [ Time Frame: 37 weeks (follow up) ] [ Designated as safety issue: No ]

Enrollment: 115
Study Start Date: October 2009
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High frequency TMS + smoking cue Device: High frequency TMS
deep TMS HADD coil
Sham Comparator: Sham TMS + smoking cue Device: Sham TMS
sham deep TMS HADD coil
Active Comparator: Low frequency TMS +smoking cue Device: Low frequency TMS
Deep TMS - HADD coil
Sham Comparator: Sham TMS - no cue Device: Sham TMS
sham deep TMS HADD coil
Active Comparator: High frequency TMS - no cue Device: High frequency TMS
deep TMS HADD coil
Active Comparator: Low frequency - no cue Device: Low frequency TMS
Deep TMS - HADD coil

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. po Bupropion (Zyban/Wellbutrin) or Varenicline (Champix)
    2. Nicotine patch/ nicotine gum
    3. CBT (Cognitive behavioral therapy)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951782

Locations
Israel
Beer-Yaacov MHC
Beer-Yaacov, Ezor Hashfela, Israel, 70350
Sponsors and Collaborators
BeerYaakov Mental Health Center
Investigators
Study Director: Oded Rosenberg, M.D. Beer Yaakov MHI
Study Director: Limor Dinur Klein Beer Yaakov MHI
  More Information

No publications provided

Responsible Party: Pinhas Dannon, Prof. Pinhas Dannon, BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier: NCT00951782     History of Changes
Other Study ID Numbers: 234-CTIL
Study First Received: July 14, 2009
Last Updated: December 19, 2013
Health Authority: United States: Institutional Review Board
Israel: Ministry of Health

Keywords provided by BeerYaakov Mental Health Center:
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Smoking
Lung Diseases, Obstructive
Respiratory Tract Diseases
Habits

ClinicalTrials.gov processed this record on July 26, 2014