- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06639594
Viabilidad de la rTMS personalizada y acelerada como adyuvante para los trastornos del control de los impulsos: un estudio piloto (RAPID)
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
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To measure the time required to the staff to conduct each ERP assessment.
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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.
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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).
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Francesco Versace, PHD, PHD
- Número de teléfono: (713) 745-7933
- Correo electrónico: fversace@mdanderson.org
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- The University of Texas MD Anderson Cancer Center
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Contacto:
- Francesco Versace, PHD,PHD
- Número de teléfono: 713-745-7933
- Correo electrónico: fversace@mdanderson.org
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Investigador principal:
- Francesco Versace, PHD,PHD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria
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rTMS exposure for treatment or research purposes in the last 6 months.
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History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.
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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).
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History of brain surgery, implanted electronic device, metal in the head.
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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)
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History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.
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Reported history of vision problems that are not treated.
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Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.
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Reports current diagnosis or history of type I diabetes.
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Currently using insulin.
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Have undergone bariatric surgery.
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Currently being enrolled in a weight loss program
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Takes any prescription or over the counter medications or supplements to control weight and/or appetite.
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Self-report a history of or current diagnosis of a mental health condition.
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Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)
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Reports (<4 hours of sleep) the day of the visit.
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Reports using marijuana on a daily basis.
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Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.
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Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).
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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.
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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).
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Being pregnant or lactating
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Reported allergies to chocolate or any ingredient in the M&M candies.
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Noise-induced hearing loss or tinnitus.
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Currently participating in any other research study.
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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
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Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intermittent theta burst stimulation
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. |
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. |
|
Experimental: Continuous theta burst stimulation
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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Safety and Adverse Events (AEs).
Periodo de tiempo: Through study completion; an average of 1 year.
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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.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francesco Versace, PHD,PHD, The Unversity of Texas MD Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-0261
- NCI-2024-08561 (Otro identificador: NCI CTRP Clinical Registry)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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