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

Обзор

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

Подробное описание

Primary Objectives:

To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:

* Recruitment: We will define recruitment as the probability of an eligible patient consenting to participate in the study. We will deem recruitment for this trial feasible if at least 70% of eligible patients consent to participate in the trial. (i.e., considering a pool of 30 eligible subjects, we consent at least 21 participants). * Tolerability: For each sequence, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS sequence. * Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.

Secondary Objectives

We will measure:

1. To measure the time required to the staff to conduct each ERP assessment. 2. 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. 3. 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).

Вмешательства

• Устройство Repetitive Transcranial Magnetic Stimulation (rTMS)
  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.

Первичные конечные точки

• Safety and Adverse Events (AEs). [Срок оценки: Through study completion; an average of 1 year.]

Критерии участия

Критерии включения

• Age 21 to 60
• BMI>30 (confirmed at in person 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 and rTMS.
• Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
• Provides written informed consent and agree to all assessments and study procedures.
• Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.

Критерии исключения

• 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):

• Investigational drugs.
• Drugs of anti or pro-convulsive action. Medications with psychotropic effects (e.g., antidepressants, antipsychotics).
• Medications known to increase risk of seizure taken within 1 week of enrollment.
• Smoking cessation medication (e.g., Zyban, Wellbutrin, Wellbutrin SR, Chantix).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The University of Texas MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT06639594 · 2024-0261 · NCI-2024-08561

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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