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Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence

Primary Purpose

Tobacco Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Continuous Theta-burst stimulation (cTBS)
Sham Continuous Theta-burst stimulation (cTBS)
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-65 yrs. of age
  2. Smoke > 5 cigarettes/day for ≥ 2 yrs, and expired carbon monoxide (CO) concentration of ≥ 8 ppm
  3. English Fluency
  4. Functional Vision (with corrective lenses as needed)

Exclusion Criteria:

  1. Use of psychotropic and antiepileptic medications in the last month
  2. Presence of an untreated illness or serious medical condition
  3. History of major neurological illness
  4. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 min., implanted electronic device, metal in the head)
  5. Any use of substances that lower seizure threshold
  6. Current or past psychosis
  7. Electroconvulsive therapy in last 6 months
  8. Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
  9. BAC greater than 0.0.
  10. Positive urine pregnancy test
  11. Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Continuous Theta-burst stimulation (cTBS)

    Sham Theta-burst stimulation

    Arm Description

    Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.

    Outcomes

    Primary Outcome Measures

    Change in the number (#) of cigarettes per day.
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarettes per day (CPD). This is measured by a core daily cigarette diary and will be measured following treatment and after making a quit attempt at: days 14, 21 and 28.
    Cigarette craving scores (#) as measured by the questionnaire of smoking urges brief (QSUb).
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarette craving. This will be measured at the end of every visit to the laboratory. The Questionnaire of Smoking Urges brief (QSUb) rages from 0 to 70. Lower scores equal less craving, meaning the lower the score, the better the outcome.
    Percent (%) correct on an inhibitory control GoGo/NoGo task.
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on inhibitory control (IC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.
    Craving regulation scores (#) on a regulation of craving task.
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on regulation of craving (ROC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.

    Secondary Outcome Measures

    Symptoms scores (#) as measured by the review of symptoms (ROS) questionnaire.
    The safety and tolerability of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG). This will be measured at the end of each cTBS treatment visit in the laboratory and each follow up visit. The Review of Symptoms (ROS) Questionnaire ranges from 0 to 75. Lower scores equal less symptoms, meaning the lower the score, the better the outcome.

    Full Information

    First Posted
    October 25, 2021
    Last Updated
    May 31, 2023
    Sponsor
    University of Missouri-Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05389670
    Brief Title
    Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence
    Official Title
    Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Missouri-Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    The purpose of this research study is to examine the effects of theta-burst Transcranial Magnetic Stimulation on inhibitory control and smoking among adult cigarette smokers. In a double-blind, sham controlled trial, investigators will examine the effects of 12 sessions of cTBS on executive function and smoking behavior.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tobacco Use Disorder

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Continuous Theta-burst stimulation (cTBS)
    Arm Type
    Experimental
    Arm Description
    Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
    Arm Title
    Sham Theta-burst stimulation
    Arm Type
    Sham Comparator
    Intervention Type
    Device
    Intervention Name(s)
    Continuous Theta-burst stimulation (cTBS)
    Intervention Description
    Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
    Intervention Type
    Device
    Intervention Name(s)
    Sham Continuous Theta-burst stimulation (cTBS)
    Intervention Description
    Sham cTBS, inhibitory-like patterned form of TMS.
    Primary Outcome Measure Information:
    Title
    Change in the number (#) of cigarettes per day.
    Description
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarettes per day (CPD). This is measured by a core daily cigarette diary and will be measured following treatment and after making a quit attempt at: days 14, 21 and 28.
    Time Frame
    2 months
    Title
    Cigarette craving scores (#) as measured by the questionnaire of smoking urges brief (QSUb).
    Description
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on cigarette craving. This will be measured at the end of every visit to the laboratory. The Questionnaire of Smoking Urges brief (QSUb) rages from 0 to 70. Lower scores equal less craving, meaning the lower the score, the better the outcome.
    Time Frame
    2 months
    Title
    Percent (%) correct on an inhibitory control GoGo/NoGo task.
    Description
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on inhibitory control (IC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.
    Time Frame
    2 months
    Title
    Craving regulation scores (#) on a regulation of craving task.
    Description
    The effects of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG) on regulation of craving (ROC) task performance. This will be measured at : baseline; after completing 12 sessions of cTBS treatment, 3-7 days following making a quit attempt and at days 14, 21 and 28 following quit attempt.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Symptoms scores (#) as measured by the review of symptoms (ROS) questionnaire.
    Description
    The safety and tolerability of 12 sessions of continuous theta burst stimulation (cTBS) to the right inferior frontal gyrus (r.IFG). This will be measured at the end of each cTBS treatment visit in the laboratory and each follow up visit. The Review of Symptoms (ROS) Questionnaire ranges from 0 to 75. Lower scores equal less symptoms, meaning the lower the score, the better the outcome.
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18-65 yrs. of age Smoke > 5 cigarettes/day for ≥ 2 yrs, and expired carbon monoxide (CO) concentration of ≥ 8 ppm English Fluency Functional Vision (with corrective lenses as needed) Exclusion Criteria: Use of psychotropic and antiepileptic medications in the last month Presence of an untreated illness or serious medical condition History of major neurological illness Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for >15 min., implanted electronic device, metal in the head) Any use of substances that lower seizure threshold Current or past psychosis Electroconvulsive therapy in last 6 months Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea BAC greater than 0.0. Positive urine pregnancy test Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Madhura Athreya, MS
    Phone
    5738822977
    Email
    athreyam@health.missouri.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brett Froeliger, PhD
    Phone
    5738824785
    Email
    froeligerb@health.missouri.edu

    12. IPD Sharing Statement

    Learn more about this trial

    Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence

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