Evaluation of Deep Transcranial Magnetic Stimulation (DTMS) With the H-ADD Coil as an Aid to Smoking Cessation.
NCT ID: NCT02126124
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
224 participants
INTERVENTIONAL
2014-08-20
2019-11-14
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Active dTMS Treatment
Brainsway Deep TMS Treatment
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.
Sham Treatment
Brainsway Sham Treatment
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
70 Years
ALL
Yes
Sponsors
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Brainsway
INDUSTRY
Responsible Party
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Principal Investigators
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Mark George, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Abraham Zangen, PhD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Kathleen Brady, MD., PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Pacific Institute of Medical Research
Los Angeles, California, United States
University of California - San Diego Medical Center
San Diego, California, 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
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
Columbia University / New York State Psychiatric Institute
New York, New York, United States
Lindner Center of HOPE, University of Cinicnnati College of Medicine
Cincinnati, Ohio, United States
Medical University Of South Carolina (MUSC)
Charleston, South Carolina, United States
Senior Adults Specialty Research
Austin, Texas, United States
Center for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada
Beer Yaacov Mental Health Center
Beer Yaacov, , Israel
Soroka Medical Center
Beersheba, , Israel
Lev Hasharon
Netanya, , Israel
Countries
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References
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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.
Other Identifiers
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BR-SMOK-01
Identifier Type: -
Identifier Source: org_study_id