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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
224
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.
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.
Pacific Institute of Medical Research
Los Angeles, California, United States
University of California - San Diego Medical Center
San Diego, California, United States
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.
Time frame: 4 week
Number of Cigarettes Smoked Per Day
The secondary objective is to compare number of cigarettes smoked per day (per diary data) for all subjects.
Time frame: 4 Weeks
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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
Advanced Mental Health Care Inc. - Royal Palm Beach
Royal Palm Beach, Florida, United States
McLean Hospital - TMS Services
Belmont, Massachusetts, United States
Premier Psychiatric Group
Lincoln, Nebraska, United States
Premier Psychiatric Group
Omaha, Nebraska, United States
Mount Sinai Hospital
New York, New York, United States
...and 8 more locations