Bayesian Neurobehavioral Phenotyping: From Mechanism Identification to Personalized Neuromodulation Treatments. R61 PHASE

NCT06991062 | Recruiting

• 2 other identifiers: 2024-1316NCI-2025-03773
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn more about whether individual differences in brain responses to emotional triggers impact rTMS (repetitive transcranial magnetic stimulation) responses in people who smoke.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

FP1 (cTBS) then F3 (iTBS)

EXPERIMENTAL

Participants will be recruit using on-line, social media, radio, and print advertisements.

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

F3 (iTBS) then Fp1 (cTBS)

EXPERIMENTAL

Participants will be recruit using on-line, social media, radio, and print advertisements.

Procedure: Repetitive Transcranial Magnetic Stimulation (rTMS)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) PROCEDURE

TMS is a non-invasive procedure in which a coil is placed over the scalp, and focused magnetic pulses are applied to parts of the brain through the coil.

F3 (iTBS) then Fp1 (cTBS); FP1 (cTBS) then F3 (iTBS)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 21 to 60 years
• Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
• Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
• Able to follow verbal and written instructions in English and complete all aspects of the study.
• Have an address and telephone number where they may be reached.
• Subjects must report current stable residence. Stable residence is a domicile in which an individual can operate as if it were their own homestead and does not include shelters, halfway houses, treatment centers, or group homes.
• Meet safety criteria for EEG.
• Be willing to vape from an e-cigarette during specified tasks.
• Meet safety criteria for rTMS. Note that if a participant is not eligible for rTMS but is eligible for EEG, they may complete the EEG portion of the study.
• Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)
• Provides written informed consent and agree to all assessments and study procedures.
• Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.

You may not qualify if:

• rTMS exposure for treatment or research purposes in the last 6 months.
• History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
• Presence or history of neurological disorders (migraine, stroke, Alzheimer's Disease and other Dementias, Parkinson's Disease, Multiple Sclerosis, Traumatic Brain Injury (TBI), increased intracranial pressure).
• History of brain surgery, implanted electronic device, metal in the head.
• Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps or sensors, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes)
• History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
• Reports vision problems that are not treated.
• Has a hairstyle not compatible with the EEG and unwilling to modify hairstyle (e.g., braids, ponytails, dreadlocks, non-removable hair extensions or wigs, etc.) to accommodate the EGG net that is required to be worn on the scalp during the experimental procedure.
• Reports current diagnosis or history of type I diabetes.
• Currently using insulin.
• Have undergone bariatric surgery.
• Currently being enrolled in a weight loss program.
• Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
• Self-report a history of or current diagnosis of a mental health condition.
• Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Francesco Versace, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Versace, PHD

CONTACT

(713) 745-7933; fversace@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 25, 2025
• Study Start: February 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2025-12

Locations

US (1)