Deep High-Frequency Repetitive Transcranial Magnetic Stimulation for Smoking Cessation

NCT00951782 | Completed Phase 2

• 1 other identifier: 234-CTIL
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Chronic Obstructive Pulmonary Disease; Smoking

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of treatment (3rd week)

  3 weeks of treatment (and additional 34 weeks of maintenance & follow-up)

Secondary Outcomes (1)

• Nicotine consumption(number of cigarets per day and cotinine levels )and craving (questionaires)at end of maintenance & follow-up(37th week)

  37 weeks (follow up)

Study Arms (6)

High frequency TMS + smoking cue

ACTIVE COMPARATOR

Device: High frequency TMS

Sham TMS + smoking cue

SHAM COMPARATOR

Device: Sham TMS

Low frequency TMS +smoking cue

ACTIVE COMPARATOR

Device: Low frequency TMS

Sham TMS - no cue

SHAM COMPARATOR

Device: Sham TMS

High frequency TMS - no cue

ACTIVE COMPARATOR

Device: High frequency TMS

Low frequency - no cue

ACTIVE COMPARATOR

Device: Low frequency TMS

Interventions

High frequency TMS DEVICE

deep TMS HADD coil

High frequency TMS + smoking cue; High frequency TMS - no cue

Sham TMS DEVICE

sham deep TMS HADD coil

Sham TMS + smoking cue; Sham TMS - no cue

Low frequency TMS DEVICE

Deep TMS - HADD coil

Low frequency - no cue; Low frequency TMS +smoking cue

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• BeerYaakov Mental Health Center: lead

Study Sites (1)

Beer-Yaacov MHC

Beer-Yaacov, Ezor Hashfela, 70350, Israel

Location

Related Publications (1)

• Dinur-Klein L, Dannon P, Hadar A, Rosenberg O, Roth Y, Kotler M, Zangen A. Smoking cessation induced by deep repetitive transcranial magnetic stimulation of the prefrontal and insular cortices: a prospective, randomized controlled trial. Biol Psychiatry. 2014 Nov 1;76(9):742-9. doi: 10.1016/j.biopsych.2014.05.020. Epub 2014 Jun 5.

  PMID: 25038985 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Smoking

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Oded Rosenberg, M.D.

  Beer Yaakov MHI

  STUDY DIRECTOR

• Limor Dinur Klein

  Beer Yaakov MHI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Pinhas Dannon

Study Record Dates

• First Submitted: July 14, 2009
• First Posted: August 4, 2009
• Study Start: October 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 20, 2013

Record last verified: 2013-12

Locations

IL (1)