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

Primary Purpose

Tobacco Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
repetitive transcranial magnetic stimulation (rTMS) 20Hz
SHAM repetitive transcranial magnetic stimulation (rTMS)
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Dependence focused on measuring Tobacco cessation, Tobacco dependence, Transcranial Magnetic Stimulation, Nicotine Dependence, Delayed Discounting

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Smokers

Non-smokers

Arm Description

Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.

Healthy adult non-smokers aged 19-55

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2009
Last Updated
July 31, 2013
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00973622
Brief Title
Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
Acronym
rTMS
Official Title
Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
Tobacco cessation, Tobacco dependence, Transcranial Magnetic Stimulation, Nicotine Dependence, Delayed Discounting

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smokers
Arm Type
Experimental
Arm Description
Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
Arm Title
Non-smokers
Arm Type
Experimental
Arm Description
Healthy adult non-smokers aged 19-55
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS) 10 Hertz (Hz)
Other Intervention Name(s)
"TMS" or Transcranial Magnetic Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
repetitive transcranial magnetic stimulation (rTMS) 20Hz
Other Intervention Name(s)
"TMS" or Transcranial Magnetic Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SHAM repetitive transcranial magnetic stimulation (rTMS)
Other Intervention Name(s)
"TMS" or Transcranial Magnetic Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
A Difference Score for the Log Value of K.
Description
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.
Time Frame
baseline and immediately after stimulation, an average of 25 seconds.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine E Sheffer, PhD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Changing Thought and Action in Tobacco Dependence With Transcranial Magnetic Stimulation

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