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Transcranial Magnetic Stimulation Effects on Nicotine Craving

This study is currently recruiting participants.
Verified September 2012 by Medical University of South Carolina
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01690130
First received: September 7, 2012
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

The proposed study will measure the change of cortical excitability during nicotine craving and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine craving and cue-reactivity among adult regular smokers.


Condition Intervention Phase
Nicotine Dependence
 Device: Transcranial Magnetic Stimulation (Neuronetics)
Device: Sham Transcranial Magnetic Stimulation
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Effects on Nicotine Craving

Resource links provided by NLM:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • the change from baseline in cue nicotine craving rating score [ Time Frame: 10 minutes before rMTS and 10 minutes after rTMS experiment ] [ Designated as safety issue: No ]
    Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100). After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.


Secondary Outcome Measures:
  • the change from baseline in cortical excitability [ Time Frame: 20 minutes before and 20 minutes after rTMS experiment ] [ Designated as safety issue: No ]

    Cortical Excitability Include:

    Resting Motor Threshold (RMT) Cortical Silent Period (CSP) Recruitment Curve (RC) Paired-pulse Studies (PP)



Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial Magnetic Stimulation
Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.
 Device: Transcranial Magnetic Stimulation (Neuronetics)
Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
Other Name: Neuronetics® Model 3600
Device: Sham Transcranial Magnetic Stimulation
The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.
Other Name: Transcutaneous Electrical Nerve Stimulation Device
Sham Comparator: Sham Transcranial Magnetic Stimulation
Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)
 Device: Transcranial Magnetic Stimulation (Neuronetics)
Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
Other Name: Neuronetics® Model 3600
Device: Sham Transcranial Magnetic Stimulation
The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.
Other Name: Transcutaneous Electrical Nerve Stimulation Device

Detailed Description:

This pilot protocol proposes to test and further develop TMS for the purpose of studying brain function in nicotine users.

Specific Primary Aims include:

Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers and explore the potential use of TMS in cigarette smokers.

Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will examine whether modulating prefrontal activity through rTMS will impact measures of craving and the reinforcing effects of nicotine.

Design:

The study was a randomized, blind, sham-controlled crossover study in which participants will involve two study visits. Participants will have an initial assessment about tobacco use habits and craving patterns. Participant will look at images related to and not related to cigarette smoking.

Participants will receive two different types of brain stimulation with repetitive TMS (10 Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed before and after each stimulus experiment.

Participants will be measured cortical excitability with TMS before and after each stimulus experiment.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Right handed males and females, between the ages of 18 and 50
  • Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year
  • Mentally capable of reading, writing, giving consent, following instructions

Exclusion Criteria:

  • history of seizures
  • taking medications that lower seizure threshold
  • implanted metal devices (e.g., pacemakers, metal plates, wires)
  • pregnant
  • history of brain surgery or history of loss of consciousness >15 minutes
  • any unstable major axis I psychiatric disorder in the past month (e.g. psychotic disorders)
  • Current substance use disorders other than nicotine and caffeine use, in the past 30 days
  • Any medication (e.g., propranolol) or unstable medical condition that may interfere with psychophysiological (e.g., heart rate) monitoring
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690130

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Xingbao Li, M.D     843-792-5729     lixi@musc.edu    
Contact: Teresa L Garner     843 8765142     garnertl@musc.edu    
Principal Investigator: Xingbao Li, M.D            
Sponsors and Collaborators
Medical University of South Carolina
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01690130     History of Changes
Other Study ID Numbers: Brain Stimulation Lab / MUSC
Study First Received: September 7, 2012
Last Updated: September 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
nicotine
craving
smoking
TMS
prefrontal cortex

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013