Back to resultsTMS-fMRI for Neural Pathway in Smokers
Primary Purpose
Nicotine Dependence
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring transcranial magnetic stimulation, fMRI, cue craving
Eligibility Criteria
Inclusion Criteria:
- Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking.
- Not received substance abuse treatment within the previous 30 days.
- Meet criteria for nicotine dependence as determined by the FTND.
- Be in stable mental and physical health.
- If female, test non-pregnant and use adequate birth control.
- No evidence of focal or diffuse brain lesion on MRI.
- Be willing to provide informed consent.
- Be able to comply with protocol requirements and likely to complete all study procedures.
Exclusion Criteria:
- Current dependence, defined by DSM-V criteria, on any psychoactive substances other than nicotine or caffeine.
- Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
- Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
- History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
- History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
- Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
- Life time history of major Axis I disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
- Self report of >21 standard alcohol drinks per week in any week in the 30 days prior to screening.
- Other forms of nicotine delivery, such as nicotine patch, electronic cigarettes
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham rTMS
Active rTMS
Arm Description
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Outcomes
Primary Outcome Measures
Changes in fMRI Neural Activation Patterns
During MRI scan in which participants will watch smoking picture, investigators will measure the change in neural activity in reward neural circuit. Whole brain imaging analysis and network analysis will be performed.
Secondary Outcome Measures
Reduction of Smoking Cue Craving
visual analog scale for cue craving. Participants will be asked ' Right now, I would rate the amount of my craving to smoke as:'. The minimum score is 0, and the Maximum score is 7. There are 10 items. The total minimum score is 0, and the total maximum score is 70. A higher score is more craving to smoke a cigarette. The fewer values are considered to be a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02665338
Brief Title
TMS-fMRI for Neural Pathway in Smokers
Official Title
Repetitive TMS Modulates Dorsal Lateral Prefrontal-Ventral Medial Prefrontal Pathway to Decrease Craving in Smokers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
We planned to enroll more participants but we could not recruit more participants. In addition, the covid-19 pandemic made the recruitment worse than the previous years.
Study Start Date
April 28, 2014 (Actual)
Primary Completion Date
June 16, 2015 (Actual)
Study Completion Date
June 16, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xingbao Li
4. Oversight
5. Study Description
Brief Summary
Cigarette smoking causes significant morbidity and mortality in the United States. Smoking cessation is difficult, with the average smoker attempting to quit five times before permanent success. Moreover, the majority of smoking quit attempts result in relapse. Brain stimulation for smoke cessation is an exciting new area that builds on advancing neuroscience knowledge concerning the functional neurocircuitry of addiction. Cortical stimulation can now be performed non-invasively by transcranial magnetic stimulation (TMS). Several studies have shown that TMS can reduce cue-elicited craving in smokers. Previous research by group has shown that a single session of 15 minutes high frequency (10 Hz) repetitive TMS (rTMS) at 100% motor threshold over the left dorsal lateral prefrontal cortex (DLPFC) can reduce cue-induced craving compared to sham TMS. However, the mechanism by which craving is reduced by rTMS is poorly understood both at behavioral and neural levels. Neuroimaging studies in nicotine dependence have revealed cue-related responses in numerous brain areas, including frontal, parietal cortices and subcortical areas. Recently functional magnetic resonance imaging (fMRI) studies by the group have shown that cue-induced craving induced brain activation in ventral medial prefrontal cortex (VMPFC), including medial frontal, orbital frontal and anterior cingulate. This Chair Research Development Fund (CRDF) pilot proposal will integrate two new techniques- TMS and fMRI to investigate DLPFC-VMPFC pathway in smokers. Using double-masked methods investigators hypothesize that cue-induced exposure will induce brain activity in VMPFC, and 15 minutes rTMS over DLPFC will reduce cue-induced craving through modulating DLPFC-VMPFC pathway (increased activity DLPFC and decreased activity VMPFC).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
transcranial magnetic stimulation, fMRI, cue craving
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
The sham TMS system will be connected to an electrical generator on a 9 V battery and electrodes will be placed over the prefrontal cortex. The regulator is triggered by the TMS machine to allow brief, microsecond, pulses of the electrical current through to the skin on the subjects' forehead. Electrical stimulation will be triggered by the TMS machine to correspond to the sham TMS pulses.
Arm Title
Active rTMS
Arm Type
Active Comparator
Arm Description
Stimulation frequency for all active subjects: 10 Hertz - Pulse train duration (on time) 5 seconds, Inter-train interval (off time) 10 seconds (15 second cycle time), Power (intensity) level 100% rMT, Total 60 trains, 15 minutes, Total pulses 3000.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation
Other Intervention Name(s)
TMS
Primary Outcome Measure Information:
Title
Changes in fMRI Neural Activation Patterns
Description
During MRI scan in which participants will watch smoking picture, investigators will measure the change in neural activity in reward neural circuit. Whole brain imaging analysis and network analysis will be performed.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Reduction of Smoking Cue Craving
Description
visual analog scale for cue craving. Participants will be asked ' Right now, I would rate the amount of my craving to smoke as:'. The minimum score is 0, and the Maximum score is 7. There are 10 items. The total minimum score is 0, and the total maximum score is 70. A higher score is more craving to smoke a cigarette. The fewer values are considered to be a better outcome.
Time Frame
pre-TMS and post-TMS approx, 30 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Smoke 10 or more cigarettes per day and have a carbon monoxide (CO) level > 10 ppm indicative of recent smoking.
Not received substance abuse treatment within the previous 30 days.
Meet criteria for nicotine dependence as determined by the FTND.
Be in stable mental and physical health.
If female, test non-pregnant and use adequate birth control.
No evidence of focal or diffuse brain lesion on MRI.
Be willing to provide informed consent.
Be able to comply with protocol requirements and likely to complete all study procedures.
Exclusion Criteria:
Current dependence, defined by DSM-V criteria, on any psychoactive substances other than nicotine or caffeine.
Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for > 15 minutes, implanted electronic device, metal in the head, or pregnancy).
History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
Unstable cardiac disease, uncontrolled hypertension, severe renal or liver insufficiency, or sleep apnea.
Life time history of major Axis I disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
Self report of >21 standard alcohol drinks per week in any week in the 30 days prior to screening.
Other forms of nicotine delivery, such as nicotine patch, electronic cigarettes
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23485014
Citation
Li X, Hartwell KJ, Owens M, Lematty T, Borckardt JJ, Hanlon CA, Brady KT, George MS. Repetitive transcranial magnetic stimulation of the dorsolateral prefrontal cortex reduces nicotine cue craving. Biol Psychiatry. 2013 Apr 15;73(8):714-20. doi: 10.1016/j.biopsych.2013.01.003. Epub 2013 Feb 26.
Results Reference
background
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TMS-fMRI for Neural Pathway in Smokers
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