Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02126124|
Recruitment Status : Completed
First Posted : April 29, 2014
Last Update Posted : December 4, 2020
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Device: Sham Treatment Device: Active dTMS Treatment||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||224 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Actual Study Start Date :||August 20, 2014|
|Actual Primary Completion Date :||November 14, 2019|
|Actual Study Completion Date :||November 14, 2019|
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
- 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.
- 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.
- Long term CQR [ Time Frame: 4 Months ]Long-term continuous quit rates (CQR) at four months.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||22 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
- 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.
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
|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|
|Other Study ID Numbers:||
|First Posted:||April 29, 2014 Key Record Dates|
|Last Update Posted:||December 4, 2020|
|Last Verified:||November 2019|
Brainsway, dTMS, Deep Transcranial Magnetic Stimulation, Smoking Cessation