RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-19

Study Completion:2028-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06991062

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.

Ages Eligible for Study:21 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 21 to 60 years 2. Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit. 3. Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit. 4. Able to follow verbal and written instructions in English and complete all aspects of the study. 5. Have an address and telephone number where they may be reached. 6. 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. 7. Meet safety criteria for EEG. 8. Be willing to vape from an e-cigarette during specified tasks. 9. 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. 10. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry) 11. Provides written informed consent and agree to all assessments and study procedures. 12. Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.	13. rTMS exposure for treatment or research purposes in the last 6 months. 14. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness. 15. 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). 16. History of brain surgery, implanted electronic device, metal in the head. 17. 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) 18. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack. 19. Reports vision problems that are not treated. 20. 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. 21. Reports current diagnosis or history of type I diabetes. 22. Currently using insulin. 23. Have undergone bariatric surgery. 24. Currently being enrolled in a weight loss program. 25. Takes any prescription or over the counter medications or supplements to control weight and/or appetite. 26. Self-report a history of or current diagnosis of a mental health condition. 27. Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months) 28. Reports \<4 hours of sleep the day of the visit 29. Reports using marijuana on a daily basis. 30. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months. 31. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). 32. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days. 33. Current use of certain medications (last 3 months): 34. Being pregnant or lactating 35. Self-reported noise-induced hearing loss or tinnitus. 36. Currently participating in any other research study. 37. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician. 37. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician. 38. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Inclusion Criteria

Exclusion Criteria

1. Age 21 to 60 years
2. Report smoking on average, 5 or more cigarettes, little cigars and/or cigarillos per day, within the past 30 days preceding the screening visit.
3. Expired carbon monoxide (CO) ≥ 6ppm and/or test positive for cotinine using a urine cotinine test on day of study visit.
4. Able to follow verbal and written instructions in English and complete all aspects of the study.
5. Have an address and telephone number where they may be reached.
6. 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.
7. Meet safety criteria for EEG.
8. Be willing to vape from an e-cigarette during specified tasks.
9. 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.
10. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry)
11. Provides written informed consent and agree to all assessments and study procedures.
12. Agrees to complete telehealth (live audio-video conference and/or phone) and in-person visits and to be contacted via text.

13. rTMS exposure for treatment or research purposes in the last 6 months.
14. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
15. 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).
16. History of brain surgery, implanted electronic device, metal in the head.
17. 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)
18. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
19. Reports vision problems that are not treated.
20. 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.
21. Reports current diagnosis or history of type I diabetes.
22. Currently using insulin.
23. Have undergone bariatric surgery.
24. Currently being enrolled in a weight loss program.
25. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
26. Self-report a history of or current diagnosis of a mental health condition.
27. Reports insomnia (\<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
28. Reports \<4 hours of sleep the day of the visit
29. Reports using marijuana on a daily basis.
30. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
31. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
32. Females who report averaging more than 7 alcoholic drinks, or males who report averaging more than 14 alcoholic drinks in a single week in the last 30 days.
33. Current use of certain medications (last 3 months):
34. Being pregnant or lactating
35. Self-reported noise-induced hearing loss or tinnitus.
36. Currently participating in any other research study.
37. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
37. Any otherwise not specified medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the Principal Investigator and/or Study Physician.
38. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Contacts and Locations

Study Contact

George Kypriotakis, PHD

CONTACT

(713) 792-5079

gkypriotakis@mdanderson.org

Principal Investigator

George Kypriotakis, PHD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

George Kypriotakis, PHD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2025-02-19

Study Completion Date2028-12-01

Study Record Updates

Study Start Date2025-02-19

Study Completion Date2028-12-01

Terms related to this study

Additional Relevant MeSH Terms

Smoking