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

Smoking Cessation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126124
• Other study ID #: BR-SMOK-01
• Status: Completed
• Phase: Phase 3
• Start date: August 20, 2014
• Est. completion date: November 14, 2019

Study information

• Verified date: November 2019
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 14, 2019
• Est. primary completion date: November 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Countries where clinical trial is conducted

United States,  Canada,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Long term CQR	Long-term continuous quit rates (CQR) at four months.	4 Months
Other	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
Primary	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	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