RECRUITING

Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study

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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

To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.

Official Title

Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study

Quick Facts

Study Start:2024-11-21

Study Completion:2027-11-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06639594

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:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 18 to 60 2. BMI\>30 (confirmed at in person visit) 3. Able to follow verbal and written instructions in English and complete all aspects of the study. 4. Have an address and telephone number where they may be reached. 5. Participants 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. 6. Meet safety criteria for EEG and rTMS. 7. Provides written informed consent and agree to all assessments and study procedures. 8. Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text. 1. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness lasting over 15 minutes or with sequelae lasting longer than one week 2. 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). 3. History of brain surgery, implanted electronic device, metal in the head. 4. First-degree family history of epilepsy, schizophrenia, depression, or bipolar disorder. 5. 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) or any other metal object in the body. 6. rTMS exposure for treatment or research purposes in the last 6 months. 7. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack. 8. Reports current diagnosis or history of type I diabetes. 9. Currently using insulin. 10. Self-report a history or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician. 11. Self-report of a history or current diagnosis of post-traumatic stress disorder or eating disorder unless cleared by study physician. 12. Current Substance Use Disorder (DAST score \>3 or use \>0 in the past year and refuses to refrain from use for the duration of the study; USAUDIT score \>15) 13. Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9 14. Individuals who report anxiety symptoms in the severe range on the GAD-7 (scores of 15 or above); or meet criteria for Panic Syndrome on the PHQ Panic module. 15. Psychiatric hospitalization or suicidal ideation within 1 year of screening date 16. Currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants). 17. Use of marijuana or other illicit drugs in the last 3 months. 18. Current or recent use (last 3 months) of smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix) or nicotine replacement therapy. 19. Have undergone bariatric surgery. 20. Currently being enrolled in a weight loss program 21. Takes any prescription or over the counter medications or supplements to control weight and/or appetite. 22. Severe insomnia (\<4 hours sleep per night with hypnotic) 23. Sleep Deprived (\<4 hours of sleep) the day of the visit 24. Current use of certain medications (last 3 months): * Investigational drugs. * Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics). 25. Medications known to increase risk of seizure taken within 1 week of enrollment 26. Being pregnant or lactating (as determined by participant self-report). 27. Reported allergies to chocolate or any ingredient in the M\&M candies. 28. Noise-induced hearing loss or tinnitus. 29. Reported history of vision problems that are not treated. 30. 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 31. 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 32. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Age 18 to 60
2. BMI\>30 (confirmed at in person visit)
3. Able to follow verbal and written instructions in English and complete all aspects of the study.
4. Have an address and telephone number where they may be reached.
5. Participants 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.
6. Meet safety criteria for EEG and rTMS.
7. Provides written informed consent and agree to all assessments and study procedures.
8. Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.
1. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness lasting over 15 minutes or with sequelae lasting longer than one week
2. 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).
3. History of brain surgery, implanted electronic device, metal in the head.
4. First-degree family history of epilepsy, schizophrenia, depression, or bipolar disorder.
5. 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) or any other metal object in the body.
6. rTMS exposure for treatment or research purposes in the last 6 months.
7. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
8. Reports current diagnosis or history of type I diabetes.
9. Currently using insulin.
10. Self-report a history or current diagnosis of schizophrenia or bipolar disorder unless cleared by study physician.
11. Self-report of a history or current diagnosis of post-traumatic stress disorder or eating disorder unless cleared by study physician.
12. Current Substance Use Disorder (DAST score \>3 or use \>0 in the past year and refuses to refrain from use for the duration of the study; USAUDIT score \>15)
13. Individuals who report depressive symptoms in the moderately severe or severe range on the PHQ-9 (scores of 15 or above); or who report current suicidal ideation on the PHQ-9
14. Individuals who report anxiety symptoms in the severe range on the GAD-7 (scores of 15 or above); or meet criteria for Panic Syndrome on the PHQ Panic module.
15. Psychiatric hospitalization or suicidal ideation within 1 year of screening date
16. Currently receiving treatment for substance abuse (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
17. Use of marijuana or other illicit drugs in the last 3 months.
18. Current or recent use (last 3 months) of smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix) or nicotine replacement therapy.
19. Have undergone bariatric surgery.
20. Currently being enrolled in a weight loss program
21. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
22. Severe insomnia (\<4 hours sleep per night with hypnotic)
23. Sleep Deprived (\<4 hours of sleep) the day of the visit
24. Current use of certain medications (last 3 months):
* Investigational drugs.
* Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
25. Medications known to increase risk of seizure taken within 1 week of enrollment
26. Being pregnant or lactating (as determined by participant self-report).
27. Reported allergies to chocolate or any ingredient in the M\&M candies.
28. Noise-induced hearing loss or tinnitus.
29. Reported history of vision problems that are not treated.
30. 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
31. 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
32. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Francesco Versace, PHD, PHD

CONTACT

(713) 745-7933

fversace@mdanderson.org

Principal Investigator

Francesco Versace, PHD,PHD

PRINCIPAL_INVESTIGATOR

The Unversity of Texas MD Anderson Cancer Center

Study Locations (Sites)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Francesco Versace, PHD,PHD, PRINCIPAL_INVESTIGATOR, The Unversity of Texas MD 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 Date2024-11-21

Study Completion Date2027-11-03

Study Record Updates

Study Start Date2024-11-21

Study Completion Date2027-11-03

Terms related to this study

Additional Relevant MeSH Terms

Impulse Control Disorder