Recruiting

NeuroControl

Sponsor:

University of Missouri-Columbia

Code:

NCT06347055

Conditions

Nicotine Dependence

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Details

Brief summary:

The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.

Conditions

Nicotine Dependence

Study ID

NCT06347055

Start date

Oct 1, 2024

Status verified date

Sep, 2024

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Mar 25, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
2. English Fluency
3. 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) or MRI.
5. Any use of substances that lower seizure threshold.
6. Current or past psychosis
7. Electroconvulsive therapy in the past 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: cTBS to Ventrolateral Prefrontal Cortex

Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the ventrolateral prefrontal cortex.

experimental: cTBS to Dorsomedial Prefrontal Cortex

Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the dorsomedial prefrontal cortex.

experimental: cTBS to Vertex

Continuous theta-burst stimulation (cTBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. cTBS will be applied to the vertex.

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Continuous theta burst rTMS

Primary outcome measure

  • Acute effects of cTBS on cognitive control [ Time Frame: 1 hour after receiving cTBS ]

Central Contacts and Locations

Central contacts

Locations

Health Neuroscience Center

Recruiting

Columbia, Missouri, United States, 65203

Contacts

Brett Froeliger, PhD

froeligerb@health.missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Keywords

  • Tobacco
  • Smoking
  • TMS
  • fMRI
  • Nicotine
  • Cognitive Control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2024-10-01.