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

NCT02126124 | Completed Phase 3 DMC

• 1 other identifier: BR-SMOK-01
• Study Type: interventional
• Target: 224
• Locations: 3 countries
• Sites: 18

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.

Conditions

Smoking Cessation

Keywords

Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Cigarettes Smoked Per Day

  4 Weeks

Other Outcomes (2)

• Long term CQR

  4 Months

• Withdrawal Symptoms

  6 Weeks

Study Arms (2)

Active dTMS Treatment

ACTIVE COMPARATOR

Brainsway Deep TMS Treatment

Device: Active dTMS Treatment

Sham Treatment

SHAM COMPARATOR

Brainsway Sham Treatment

Device: Sham Treatment

Interventions

Sham Treatment DEVICE

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.

Also known as: Brainsway Sham Treatment

Sham Treatment

Active dTMS Treatment DEVICE

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.

Also known as: Brainsway Deep TMS Treatment

Active dTMS Treatment

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brainsway: lead

Study Sites (18)

Pacific Institute of Medical Research

Los Angeles, California, 90024, United States

Location

University of California - San Diego Medical Center

San Diego, California, 92103, United States

Location

TMS Center of Colorado

Denver, Colorado, 80222, United States

Location

University of Florida College of Medicine

Gainesville, Florida, 32611, United States

Location

Advanced Mental Health Care Inc. - Juno Beach

Juno Beach, Florida, 33408, United States

Location

Advanced Mental Health Care Inc. - Royal Palm Beach

Royal Palm Beach, Florida, 33411, United States

Location

McLean Hospital - TMS Services

Belmont, Massachusetts, 02478, United States

Location

Premier Psychiatric Group

Lincoln, Nebraska, 68526, United States

Location

Premier Psychiatric Group

Omaha, Nebraska, 68130, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Columbia University / New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Lindner Center of HOPE, University of Cinicnnati College of Medicine

Cincinnati, Ohio, 45040, United States

Location

Medical University Of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Center for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Location

Beer Yaacov Mental Health Center

Beer Yaacov, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Lev Hasharon

Netanya, Israel

Location

Related Publications (1)

• 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.

  PMID: 34505368 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2014
• First Posted: April 29, 2014
• Study Start: August 20, 2014
• Primary Completion: November 14, 2019
• Study Completion: November 14, 2019
• Last Updated: December 4, 2020

Record last verified: 2019-11

Locations

US (14); CA (1); IL (3)