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Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation (rTMS)

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ClinicalTrials.gov Identifier: NCT00973622
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : September 24, 2013
Last Update Posted : September 24, 2013
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE August 26, 2009
First Posted Date  ICMJE September 9, 2009
Results First Submitted Date  ICMJE January 23, 2013
Results First Posted Date  ICMJE September 24, 2013
Last Update Posted Date September 24, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
A Difference Score for the Log Value of K. [ Time Frame: baseline and immediately after stimulation, an average of 25 seconds. ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Determine if increasing the activity in the DLPFC alters decision-making, as measured by delayed discounting, and cigarette consumption, as measured by the number of cigarettes smoked in the 24 hours after the rTMS. [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2009)
Determine how limbic activation by the presence of absence of nicotine affects decision-making and interacts with rTMS for smokers. [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
Official Title  ICMJE Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
Brief Summary This study will examine the effects of high frequency, repetitive Transcranial Magnetic Stimulation (rTMS) on decision-making and smoking behavior.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
    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 Name: "TMS" or Transcranial Magnetic Stimulation
  • Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz
    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 Name: "TMS" or Transcranial Magnetic Stimulation
  • Device: SHAM repetitive transcranial magnetic stimulation (rTMS)
    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 Name: "TMS" or Transcranial Magnetic Stimulation
Study Arms  ICMJE
  • Experimental: Smokers
    Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
    Interventions:
    • Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
    • Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz
    • Device: SHAM repetitive transcranial magnetic stimulation (rTMS)
  • Experimental: Non-smokers
    Healthy adult non-smokers aged 19-55
    Interventions:
    • Device: repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
    • Device: repetitive transcranial magnetic stimulation (rTMS) 20Hz
    • Device: SHAM repetitive transcranial magnetic stimulation (rTMS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 31, 2013)
66
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2009)
40
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00973622
Other Study ID Numbers  ICMJE 110881
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christine E Sheffer, PhD University of Arkansas
PRS Account University of Arkansas
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP