Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation (rTMS)
July 31, 2013 updated by: University of Arkansas
This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
Study Overview
Status
Completed
Conditions
Detailed Description
Tobacco use is the greatest cause of preventable death in the US and cigarette smokers exhibit substantial relapse following treatment.
Understanding the brain mechanisms involved in tobacco dependence is an important step toward reducing the high rate of relapse associated with current behavioral and pharmacological treatments for smoking cessation.
This study seeks to examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
A concept central to this study is that "quitting" tobacco necessitates making conscious choices not to smoke (to delay gratification) and these choices are influenced by the balance of activity between the frontal-parietal systems that process the value of rewards and limbic systems that are involved with immediate gratification.
We aim to: 1) determine how two different levels of cortical excitation (10 Hz and 20Hz), induced by different rTMS frequencies, influence reward and risk-taking choices and cigarette consumption.
Additionally, we aim to 2) determine how limbic activation due to acute nicotine withdrawal and/or satiation modifies the effects in aim 1. Twenty non-smoking and 20 smoking participants will receive two levels of high frequency rTMS and comparable sham stimulation (using electrical scalp stimulation) delivered over the left prefrontal cortex.
Smokers will also crossover between nicotine satiation and acute withdrawal conditions to determine how rTMS interacts with limbic activation associated with nicotine use and withdrawal.
In addition, changes in preattentional (brainstem-thalamus processing as measured using the P50 midlatency auditory evoked potential) and attentional (thalamocortical processing as measured using the Psychomotor Vigilance Task; PVT) will be assessed before and after treatment to quantitatively determine changes in preattentional/arousal and attentional function.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Plans to quit smoking in the next 30 days if they desire to be a smoking participant
- Current use of any medications for tobacco cessation (i.e. nicotine replacement, bupropion, varenicline, etc.)
- A report of a high motivation to quit smoking (score 7 or great on the Motivation scale)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Smokers
Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
Experimental: Non-smokers
Healthy adult non-smokers aged 19-55
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A Difference Score for the Log Value of K.
Time Frame: baseline and immediately after stimulation, an average of 25 seconds.
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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.
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baseline and immediately after stimulation, an average of 25 seconds.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christine E Sheffer, PhD, University of Arkansas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
August 26, 2009
First Submitted That Met QC Criteria
September 4, 2009
First Posted (Estimate)
September 9, 2009
Study Record Updates
Last Update Posted (Estimate)
September 24, 2013
Last Update Submitted That Met QC Criteria
July 31, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 110881
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