Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation (TMS)
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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: deep TMS HADD coil Device: sham deep TMS HADD coil |
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) |
- 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 ]
- 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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Real High Frequency Stimulation
'nicotine' photographs presentation + real TMS in 10 HZ frequency
|
Device: deep TMS HADD coil
'nicotine' photographs presentation + TMS 10 Hz stimulation
|
|
Sham Comparator: Sham Stimulation
'nicotine' photographs presentation + sham TMS
|
Device: sham deep TMS HADD coil
'nicotine' photographs presentation + sham TMS
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- po Bupropion (Zyban/Wellbutrin) or Varenicline (Champix)
- Nicotine patch/ nicotine gum
- 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| Contact: Limor Dinur Klein | 972-54-3301324 | limordinur@gmail.com |
| Israel | |
| Beer-Yaacov MHC | Recruiting |
| Beer-Yaacov, Ezor Hashfela, Israel, 70350 | |
| Sub-Investigator: Oded Rosenberg, M.D. | |
| Sub-Investigator: Limor Dinur Klein | |
| 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: | October 26, 2011 |
| 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 June 17, 2013