Transcranial Magnetic Stimulation Effects on Nicotine Craving

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Nicotine Dependence

Treatments: Device: Transcranial Magnetic Stimulation (Neuronetics); Device: Sham Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01690130

Brain Stimulation Lab / MUSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Transcranial Magnetic Stimulation

Experimental group

Description:

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.

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation (Neuronetics)

Sham Transcranial Magnetic Stimulation

Sham Comparator group

Description:

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)

Treatment:

Device: Sham Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation (Neuronetics)