NCT03960138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2021

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 10, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

May 10, 2019

Results QC Date

August 5, 2022

Last Update Submit

March 9, 2023

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (5)

  • The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Change in Behavioral Inhibition Between Baseline and 1 Hour Post Treatment.

    Changes in errors of omission on an inhibitory control task performed prior to and immediately after cTBS, and changes in errors of omission on an inhibitory control task performed prior to and immediately after iTBS. Outcomes will be measured as the mean change in behavioral performance percent correct on inhibition trials between baseline and 1 hour post treatment. Scores on the inhibitory control task range from 0% correct to 100% correct, and the change from pre-post TBS is expressed as a percent increase or decrease in performance. Positive values represent an improved outcome, whereas negative values represent a worse outcome.

    1 hour

  • The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 1 Hour Post Treatment.

    Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 1 hour post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 1 hour post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.

    1 hour

  • The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 24hrs Post Treatment Between Conditions.

    Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 24hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 24 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.

    24 hours

  • The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Craving to Smoke 48hrs Post Treatment Between Conditions.

    Changes in self-reported craving to smoke will be assessed using the Questionnaire on Smoking Urges brief (QSUb) at 48hrs post session on each of three conditions (Baseline, cTBS, iTBS). The values are calculated as the mean of the scores between conditions at 48 hours post session. Scores on the QSUb range from 10 to 70. The lower the score, the better the outcome.

    48 hours

  • The Effects of cTBS vs. iTBS TMS Applied to the r.IFG on Changes in Hyperdirect Brain Circuit Function Between Pre and Post Session.

    Changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after cTBS, and changes in inhibitory control task functional connectivity between the r.IFG and nodes within the hyperdirect pathway (r.SMA, r.STN) prior to and immediately after iTBS. Outcomes will be measured as the transformed correlation (rZ value) of BOLD functional connectivity collected during the inhibitory task. The higher the rZ, the better the outcome.

    1 hour

Study Arms (2)

Intermittent Theta-burst stimulation (iTBS)

EXPERIMENTAL

Cross-over design - participants will receive both experimental treatments.

Device: Intermittent Theta-burst stimulation (iTBS)Device: Continuous Theta-burst stimulation (cTBS)

Continuous Theta-burst stimulation (cTBS)

EXPERIMENTAL

Cross-over design - participants will receive both experimental treatments.

Device: Intermittent Theta-burst stimulation (iTBS)Device: Continuous Theta-burst stimulation (cTBS)

Interventions

Intermittent Theta-burst stimulation (iTBS)DEVICE

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. 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 Theta-burst stimulation (cTBS)Intermittent Theta-burst stimulation (iTBS)
Continuous Theta-burst stimulation (cTBS)DEVICE

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.

Continuous Theta-burst stimulation (cTBS)Intermittent Theta-burst stimulation (iTBS)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Be between the ages of 18 and 65.
  • Be in stable mental and physical health.
  • Be willing to provide informed consent.
  • Be able to comply with protocol requirements and likely to complete all study procedures.
  • Be a current nicotine dependent cigarette smoker (smoke ≥10 cigs/day) with a minimum smoking history of smoking an average of ≥ 10 cigs/day over the past two years.

You may not qualify if:

  • \. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
  • \. Contraindication to TMS (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, as indicated by a positive urine pregnancy test at screening).
  • \. Any use of substances that lower seizure threshold (such as thyroid medications or cocaine).
  • \. 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.
  • \. BAC greater than 0.0. 8. Any other condition or concern that in the Investigator's opinion would impact participant safety, compliance with study instructions, or potentially confound the interpretation of the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri - Columbia

Columbia, Missouri, 65211, United States

Location

Related Publications (2)

  • Froeliger B, McConnell PA, Bell S, Sweitzer M, Kozink RV, Eichberg C, Hallyburton M, Kaiser N, Gray KM, McClernon FJ. Association Between Baseline Corticothalamic-Mediated Inhibitory Control and Smoking Relapse Vulnerability. JAMA Psychiatry. 2017 Apr 1;74(4):379-386. doi: 10.1001/jamapsychiatry.2017.0017.

    PMID: 28249070BACKGROUND

  • Upton S, Brown AA, Ithman M, Newman-Norlund R, Sahlem G, Prisciandaro JJ, McClure EA, Froeliger B. Effects of Hyperdirect Pathway Theta Burst Transcranial Magnetic Stimulation on Inhibitory Control, Craving, and Smoking in Adults With Nicotine Dependence: A Double-Blind, Randomized Crossover Trial. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Nov;8(11):1156-1165. doi: 10.1016/j.bpsc.2023.07.014. Epub 2023 Aug 9.

    PMID: 37567363DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Brett Froeliger
Organization
University of Missouri
froeligerb@health.missouri.edu
5738824785

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Psychiatry

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 22, 2019

Study Start

September 26, 2019

Primary Completion

April 25, 2021

Study Completion

April 25, 2021

Last Updated

March 10, 2023

Results First Posted

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)