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Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02126124
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : December 4, 2020
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE April 27, 2014
First Posted Date  ICMJE April 29, 2014
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE August 20, 2014
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
Continuous Quit Rate [ Time Frame: 4 week ]
The primary objective is to compare the four-week continuous quit rate (CQR), representing abstinence during a consecutive 4 week period during the treatment phase, between the two treatment groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2014)
Number of Cigarettes Smoked Per Day [ Time Frame: 4 Weeks ]
The secondary objective is to compare number of cigarettes smoked per day (per diary data) for all subjects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2014)
  • Long term CQR [ Time Frame: 4 Months ]
    Long-term continuous quit rates (CQR) at four months.
  • Withdrawal Symptoms [ Time Frame: 6 Weeks ]
    Effect on withdrawal symptoms as measured by weekly scales measuring nicotine craving and dependence/withdrawal, including Fagerstrom Test for Nicotine Dependence (FTND), Minnesota Nicotine Withdrawal Scale Self-Report (MNWS), Tobacco Craving Questionnaire-Short Form (TCQ-SF) and Nicotine Craving Scale.
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
Official Title  ICMJE A Prospective, Double Blind, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Deep Transcranial Magnetic Stimulation (DTMS) (With the H-ADD Coil) Intended as an Aid to Smoking Cessation.
Brief Summary The purpose of the study is to evaluate the safety and efficacy of DTMS compared to sham treatment as an aid to smoking cessation in chronic, heavy (>10 cigarettes/day) cigarette smokers.
Detailed Description This is a multi center, randomized, double blind study to evaluate the safety and effectiveness of the device as an aid to smoking cessation. Treatment will be administered over a 6 week period and follow-up assessments will be conducted at 4 months. The clinical study design includes multiple measurements of safety and effectiveness parameters. The design is meant to demonstrate that the device shows superiority compared to sham treatment over six treatment weeks, at the 4 months follow up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Device: Sham Treatment
    In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the the brain.
    Other Name: Brainsway Sham Treatment
  • Device: Active dTMS Treatment
    Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions.
    Other Name: Brainsway Deep TMS Treatment
Study Arms  ICMJE
  • Active Comparator: Active dTMS Treatment
    Brainsway Deep TMS Treatment
    Intervention: Device: Active dTMS Treatment
  • Sham Comparator: Sham Treatment
    Brainsway Sham Treatment
    Intervention: Device: Sham Treatment
Publications * Zangen A, Moshe H, Martinez D, Barnea-Ygael N, Vapnik T, Bystritsky A, Duffy W, Toder D, Casuto L, Grosz ML, Nunes EV, Ward H, Tendler A, Feifel D, Morales O, Roth Y, Iosifescu DV, Winston J, Wirecki T, Stein A, Deutsch F, Li X, George MS. Repetitive transcranial magnetic stimulation for smoking cessation: a pivotal multicenter double-blind randomized controlled trial. World Psychiatry. 2021 Oct;20(3):397-404. doi: 10.1002/wps.20905.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 27, 2014)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 14, 2019
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects, 22-70 years old.
  • Chronic, heavy (>10 cigarettes/day) smokers, who smoke for more than 1 year, with no period of abstinence for greater than 3 months during the past year.
  • Subjects who are motivated to quit smoking (with responses "very likely," or "somewhat likely" to the motivation questionnaire).
  • Satisfactory answers on safety screening questionnaire for transcranial magnetic stimulation (Keel 2001).
  • Gave informed consent for participation in the study.

Exclusion Criteria:

  • Currently on Nicotine Replacement Therapy (NRT) or smoking cessation drugs (e.g., Zyban, Chantix, etc.) or undergoing behavioral smoking cessation interventions
  • Cognitive or functional disability, diagnosed according to DSM-IV-TR criteria.
  • Active psychiatric disorder according to DSM IV (Axis I and Axis II) criteria within the last year.
  • Current alcohol or other substance abuse or dependence.
  • Alcohol or other substance abuse or dependence during the last 12 months before recruitment.
  • Subject is smoking any other form of tobacco or other substances.
  • Subject is taking psychotropic medications on a regular basis.
  • Subjects with a high risk for severe violence or suicidality as assessed during the screening interview.
  • Subjects who suffer from an unstable physical disease such as high blood pressure (>150 mmHg systolic / diastolic > 110 mmHg) or acute, unstable cardiac disease.
  • History of epilepsy or seizure (EXCEPT those therapeutically induced by ECT).
  • Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head injury or trauma with loss of consciousness for > 5 minutes.
  • History of any metal in the head (outside the mouth).
  • Metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
  • Individuals with a significant neurological disorder or insult including, but not limited to:

    • Any condition likely to be associated with increased intracranial pressure
    • Space occupying brain lesion
    • History of cerebrovascular accident
    • Transient ischemic attack within two years
    • Cerebral aneurysm
    • Dementia
    • Mini Mental State Exam score of less than or equal to 24
    • Parkinson's disease
    • Huntington's chorea
    • Multiple sclerosis
  • Subjects suffering from frequent and severe migraine headaches.
  • Subjects suffering from significant hearing loss.
  • Subjects taking pro-convulsant medications (e.g., antidepressants or antipsychotic medications).
  • Previous treatment with TMS.
  • Subjects who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the experiment.
  • Participation in a clinical trial within the last 30 days before the beginning of this clinical trial or similar participation in another clinical trial.
  • Known or suspected pregnancy or lactation.
  • Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 70 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 Canada,   Israel,   United States
Removed Location Countries Brazil,   Germany
Administrative Information
NCT Number  ICMJE NCT02126124
Other Study ID Numbers  ICMJE BR-SMOK-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Brainsway
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Brainsway
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark George, MD Medical University of South Carolina
Principal Investigator: Abraham Zangen, PhD Soroka University Medical Center
Principal Investigator: Kathleen Brady, MD., PhD Medical University of South Carolina
PRS Account Brainsway
Verification Date November 2019

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