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

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.

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Device: Active dTMS Treatment; Device: Sham Treatment

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
• Enrollment (Anticipated): 224
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Center for Addiction and Mental Health (CAMH)
• Israel
  • Beer Sheva, Israel
    • Soroka Medical Center
  • Beer Yaacov, Israel
    • Beer Yaacov Mental Health Center
  • Netanya, Israel
    • Lev Hasharon
• United States
  • California
    • Los Angeles, California, United States, 90024
      • Pacific Institute of Medical Research
    • San Diego, California, United States, 92103
      • University Of California - San Diego Medical Center
  • Colorado
    • Denver, Colorado, United States, 80222
      • TMS Center of Colorado
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida College of Medicine
    • Juno Beach, Florida, United States, 33408
      • Advanced Mental Health Care Inc. - Juno Beach
    • Royal Palm Beach, Florida, United States, 33411
      • Advanced Mental Health Care Inc. - Royal Palm Beach
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital - TMS Services
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Premier Psychiatric Group
    • Omaha, Nebraska, United States, 68130
      • Premier Psychiatric Group
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10032
      • Columbia University / New York State Psychiatric Institute
  • Ohio
    • Cincinnati, Ohio, United States, 45040
      • Lindner Center of HOPE, University of Cinicnnati College of Medicine
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Brainsway Sham Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continuous Quit Rate	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.	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cigarettes Smoked Per Day	The secondary objective is to compare number of cigarettes smoked per day (per diary data) for all subjects.	4 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term CQR	Long-term continuous quit rates (CQR) at four months.	4 Months
Withdrawal Symptoms	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.	6 Weeks

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2014
• Primary Completion (Actual): November 14, 2019
• Study Completion (Actual): November 14, 2019

Study Registration Dates

• First Submitted: April 27, 2014
• First Submitted That Met QC Criteria: April 27, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation
• Other Study ID Numbers: BR-SMOK-01