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Trial record 2 of 38 for:    tms smoking

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

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ClinicalTrials.gov Identifier: NCT02126124
Recruitment Status : Recruiting
First Posted : April 29, 2014
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Brainsway

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Device: Sham Treatment Device: Active dTMS Treatment Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active dTMS Treatment
Brainsway Deep TMS 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

Sham Comparator: Sham Treatment
Brainsway Sham Treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Long term CQR [ Time Frame: 4 Months ]
    Long-term continuous quit rates (CQR) at four months.

  2. 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.



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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126124


Contacts
Contact: Hagar Moshe 972-523845102 hagarmo@Brainsway.com
Contact: Amit Ginou 972-526051372 amit@Brainsway.com

Locations
United States, California
Pacific Institute of Medical Research Recruiting
Los Angeles, California, United States, 90024
Contact: Christina Fosteson, Bc    310-208-7144    cfosteson@pacificmedresearch.com   
Principal Investigator: Tanya Vapnik, PhD         
University of California - San Diego Medical Center Recruiting
San Diego, California, United States, 92103
Contact: Nicholas Schaffner    619-543-5978    nschaffner@ucsd.edu   
Principal Investigator: David Feifel, MD         
United States, Colorado
TMS Center of Colorado Recruiting
Denver, Colorado, United States, 80222
Contact: Claire Stephenson    303-884-3867    claire@tmscenterofcolorado.com   
Principal Investigator: Theodore Wirecki, MD         
United States, Florida
University of Florida College of Medicine Recruiting
Gainesville, Florida, United States, 32611
Contact: Dana Mason    352-273-8540    dmason@ufl.edu   
Principal Investigator: Herbert Ward, MD         
Advanced Mental Health Care Inc. - Juno Beach Recruiting
Juno Beach, Florida, United States, 33408
Contact: Elyssa Sisko    561-333-8884    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
Advanced Mental Health Care Inc. - Royal Palm Beach Recruiting
Royal Palm Beach, Florida, United States, 33411
Contact: Elyssa Sisko    561-333-8884    elyssasisko@gmail.com   
Principal Investigator: Aron Tendler, MD         
United States, Massachusetts
McLean Hospital - TMS Services Active, not recruiting
Belmont, Massachusetts, United States, 02478
United States, Nebraska
Premier Psychiatric Group Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Kelly Espenschade    402-476-6060    kespenschade@premierpsych.com   
Principal Investigator: Walter J Duffy, MD         
Premier Psychiatric Group Recruiting
Omaha, Nebraska, United States, 68130
Contact: Kelly Espenschade    402-476-6060    kespenschade@premierpsych.com   
Principal Investigator: Walter J Duffy, MD         
United States, New York
Mount Sinai Hospital Active, not recruiting
New York, New York, United States, 10029
Columbia University / New York State Psychiatric Institute Recruiting
New York, New York, United States, 10032
Contact: Alexander Grassetti    646-774-7654    grasset@nyspi.columbia.edu   
Contact: Dinnisa Chang    646-7747654    changdi@nyspi.columbia.edu   
Principal Investigator: Ned Nunes, MD         
United States, Ohio
Lindner Center of HOPE, University of Cinicnnati College of Medicine Recruiting
Cincinnati, Ohio, United States, 45040
Contact: Anna Guerdjikova    513-536-0721    anna.guerdjikova@lindnercenter.org   
Principal Investigator: John Hawkins, MD         
United States, South Carolina
Medical University Of South Carolina (MUSC) Recruiting
Charleston, South Carolina, United States, 29425
Contact: Jkeonye Moss    843-876-5141    mosjk@musc.edu   
Principal Investigator: Mark George, MD         
United States, Texas
Senior Adults Specialty Research Recruiting
Austin, Texas, United States, 78757
Contact: Meredith Draper, Ph.D    512-407-8628    mdraper@senioradults.net   
Principal Investigator: Jaron L. Winston, MD         
Canada, Ontario
Center for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada
Contact: Mawahib Semeralul    416 535 8501 ext 6434    Mawahib.Semeralul@camh.ca   
Principal Investigator: Daniel Blumberger, MD         
Israel
Soroka Medical Center Recruiting
Beer Sheva, Israel
Contact: Lihi Bokovza    972-52-8512367    Lihi.bokovza@gmail.com   
Contact: Abraham Zangen         
Principal Investigator: Doron Toder         
Principal Investigator: Abraham Zangen         
Beer Yaacov Mental Health Center Recruiting
Beer Yaacov, Israel
Contact: Dikla Shmuel, MD    972-54-2494688    dikla.shmuel@moh.health.gov.il   
Principal Investigator: Yehiel Lefkovitz         
Lev Hasharon Active, not recruiting
Netanya, Israel
Sponsors and Collaborators
Brainsway
Investigators
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

Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT02126124     History of Changes
Other Study ID Numbers: BR-SMOK-01
First Posted: April 29, 2014    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: February 2017

Keywords provided by Brainsway:
Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation