- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389670
Theta-burst Repetitive Transcranial Magnetic Stimulation (TBS) of the Right Inferior Frontal Gyrus for Treatment of Nicotine Dependence
November 28, 2023 updated by: Brett Froeliger, University of Missouri-Columbia
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Madhura Athreya, MS
- Phone Number: 5738822977
- Email: athreyam@health.missouri.edu
Study Contact Backup
- Name: Brett Froeliger, PhD
- Phone Number: 5738824785
- Email: froeligerb@health.missouri.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous Theta-burst stimulation (cTBS)
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.
|
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 Comparator: Sham Theta-burst stimulation
|
Sham cTBS, inhibitory-like patterned form of TMS.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the number (#) of cigarettes per day.
Time Frame: 2 months
|
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).
Time Frame: 2 months
|
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.
Time Frame: 2 months
|
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.
Time Frame: 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Symptoms scores (#) as measured by the review of symptoms (ROS) questionnaire.
Time Frame: 2 months
|
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.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
January 31, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
December 4, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2074722
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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