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Trial record 21 of 1361 for:    transcranial magnetic stimulation

Transcranial Magnetic Stimulation Effects on Nicotine Craving

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ClinicalTrials.gov Identifier: NCT01690130
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Brief Summary:
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 or disease Intervention/treatment Phase
Nicotine Dependence Device: Transcranial Magnetic Stimulation (Neuronetics) Device: Sham Transcranial Magnetic Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Effects on Nicotine Craving
Study Start Date : June 2009
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. the Change From Baseline in Cue Nicotine Craving Rating Score [ Time Frame: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes) ]
    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) 0 means least amount of craving and 100 means the maximum amount of craving. 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 :
  1. the Change From Baseline in Resting Motor Threshold [ Time Frame: 20 minutes before (baseline) and 20 minutes after rTMS experiment ]
    Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690130


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01690130     History of Changes
Other Study ID Numbers: Brain Stimulation Lab / MUSC
First Posted: September 21, 2012    Key Record Dates
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018
Last Verified: October 2018

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

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