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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-08561 | Other Identifier | NCI CTRP Clinical Registry |
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To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Primary Objectives:
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
Secondary Objectives
We will measure:
To measure the time required to the staff to conduct each ERP assessment.
To measure the time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent theta burst stimulation | Experimental | Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive intermittent theta burst stimulation (iTBS)" for 3 sessions; in week 2 participants receive continuous theta burst stimulation ciTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. |
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| Continuous theta burst stimulation | Experimental | Participants undergo rTMS once a week for 2 weeks. In week 1 participants receive continuous theta burst stimulation (cTBS) for 3 sessions; in week 2 participants receive intermittent theta burst stimulation (iTBS) for 3 sessions. Additionally, participants complete cued food delivery task assessment and undergo saliva sample collection on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | RTMS is a non-invasive procedure in which a coil is placed over the scalp, and powerful, focused magnetic pulses are applied to parts of the brain through the coil. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria
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.
Reported history of vision problems that are not treated.
Has a hairstyle not compatible with the EEG 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)
Reports (<4 hours of sleep) the day of the visit.
Reports using marijuana on a daily basis.
Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
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.
Current use of certain medications (last 3 months):
Being pregnant or lactating
Reported allergies to chocolate or any ingredient in the M&M candies.
Noise-induced hearing loss or tinnitus.
Currently participating in any other research study.
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
Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Francesco Versace, PHD, PHD | Contact | (713) 745-7933 | fversace@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Versace, PHD,PHD | The Unversity of Texas MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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