Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
rTMS
1 other identifier
interventional
66
1 country
1
Brief Summary
This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2009
CompletedFirst Posted
Study publicly available on registry
September 9, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
September 24, 2013
CompletedSeptember 24, 2013
July 1, 2013
2.3 years
August 26, 2009
January 23, 2013
July 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
A Difference Score for the Log Value of K.
K is a output value, a summary statistic, derived from a hyperbolic function that summarizes the rate at which monetary values are discounted according to the time they are received. The value of K can either increase or decrease from its baseline value. For example, an increase in K would indicate that the participant is choosing to receive larger amounts of money at a later point in time. A decrease would suggest the opposite - lesser amounts of money at an earlier point in time). The difference score is calculated from baseline to that immediately after 10 or 20 Hz rTMS.
baseline and immediately after stimulation, an average of 25 seconds.
Study Arms (2)
Smokers
EXPERIMENTALHealthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
Non-smokers
EXPERIMENTALHealthy adult non-smokers aged 19-55
Interventions
All participants will receive 90 10-pulse trains of 1 sec duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.
All participants will receive 45 20-pulse trains of 1 second duration with an interval of 20 seconds. Smokers will receive the treatment twice, once in a nicotine-satiated condition, and once in a nicotine-withdrawal condition.
The look and sound of active rTMS is reproduced with the same coil used in the active conditions. The magnetic field in the sham coil is markedly attenuated at only 5% of stimulator output. The feel of active stimulation will be reproduced by delivering monophasic current pulses to the left, frontalis muscle with a Isolated Stimulator and two carbon rubber electrodes. Smokers will receive Sham rTMS in both the nicotine-satiated and nicotine-withdrawal conditions.
Eligibility Criteria
You may qualify if:
- Age 19-55
- Must speak English
- Must be right handed
- Must pass the Transcranial Magnetic Stimulation Adult Safety and Screening Questionnaire (TAAS)
- Smoking participants must be highly dependent with a score of 6 or greater on the Fagerstrom Test for Nicotine Dependence
You may not qualify if:
- Positive test for drugs of abuse
- Positive pregnancy test
- A personal or family history of epilepsy
- A history of anticonvulsant medication use
- A personal history of head injury
- A history of aneurysm, stroke, or previous cranial neurosurgery
- A diagnosis of bipolar disorder
- A neurological or psychiatric disorder for which hospitalization was required
- Tinnitus
- Metal implants in the head, neck or cochlea
- A pacemaker
- Migraines
- A history of taking medications that lower seizure threshold (i.e. such as tricyclic antidepressants or bupropion)
- Claustrophobia (due to the MRI)
- Used any form of tobacco in the past two years if they desire to be a non-smoking participant
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We experienced significant subject attrition among smokers. We did not experience such attrition among nonsmokers. Also, six smokers were withdrawn because the MRI screen revealed brain abnormalities. No nonsmokers were withdrawn for this reason.
Results Point of Contact
- Title
- Christine Sheffer, PhD
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Christine E Sheffer, PhD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2009
First Posted
September 9, 2009
Study Start
October 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
September 24, 2013
Results First Posted
September 24, 2013
Record last verified: 2013-07