Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedAugust 14, 2024
November 1, 2023
7 months
October 25, 2021
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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.
2 months
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.
2 months
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.
2 months
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.
2 months
Secondary Outcomes (1)
Symptoms scores (#) as measured by the review of symptoms (ROS) questionnaire.
2 months
Study Arms (2)
Continuous Theta-burst stimulation (cTBS)
EXPERIMENTALTheta-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.
Sham Theta-burst stimulation
SHAM COMPARATORInterventions
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.
Sham cTBS, inhibitory-like patterned form of TMS.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 25, 2021
First Posted
May 25, 2022
Study Start
July 1, 2025
Primary Completion
January 31, 2026
Study Completion
April 1, 2026
Last Updated
August 14, 2024
Record last verified: 2023-11