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Viabilidad de la rTMS personalizada y acelerada como adyuvante para los trastornos del control de los impulsos: un estudio piloto (RAPID)

17 de septiembre de 2026 actualizado por: M.D. Anderson Cancer Center

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

Descripción general del estudio

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:

  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).

Tipo de estudio

Intervencionista

Inscripción (Estimado)

30

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Francesco Versace, PHD, PHD
  • Número de teléfono: (713) 745-7933
  • Correo electrónico: fversace@mdanderson.org

Ubicaciones de estudio

    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Reclutamiento
        • The University of Texas MD Anderson Cancer Center
        • Contacto:
        • Investigador principal:
          • Francesco Versace, PHD,PHD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  1. Age 21 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. 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.
  6. Meet safety criteria for EEG and rTMS.
  7. Willing and able to independently remove any metal from the neck and above for rTMS procedures (e.g., jewelry, retainer)
  8. Provides written informed consent and agree to all assessments and study procedures.
  9. Agrees to complete telehealth (live audio-video conference and phone) and in-person visits and to be contacted via text.

Exclusion Criteria

  1. rTMS exposure for treatment or research purposes in the last 6 months.

  2. History of seizure, epilepsy, syncope, fainting episode, or head trauma resulting in loss of consciousness.

  3. 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).

  4. History of brain surgery, implanted electronic device, metal in the head.

  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)

  6. History of or currently under medical care for myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke, or transient ischemic attack.

  7. Reported history of vision problems that are not treated.

  8. Has a hairstyle not compatible with the EEG net that is required to be worn on the scalp during the experimental procedure.

  9. Reports current diagnosis or history of type I diabetes.

  10. Currently using insulin.

  11. Have undergone bariatric surgery.

  12. Currently being enrolled in a weight loss program

  13. Takes any prescription or over the counter medications or supplements to control weight and/or appetite.

  14. Self-report a history of or current diagnosis of a mental health condition.

  15. Reports insomnia (<4 hours sleep per night, in 3 or more nights per week in the last 3 months)

  16. Reports (<4 hours of sleep) the day of the visit.

  17. Reports using marijuana on a daily basis.

  18. Reports having used any other illicit drugs (other than marijuana) or prescription medications for non-medical reasons in the last 12 months.

  19. Currently receiving treatment for substance use disorder (e.g., alcohol, opioids, cocaine, marijuana, or stimulants).

  20. 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.

  21. 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).
  22. Being pregnant or lactating

  23. Reported allergies to chocolate or any ingredient in the M&M candies.

  24. Noise-induced hearing loss or tinnitus.

  25. Currently participating in any other research study.

  26. 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

  27. Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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.

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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Francesco Versace, PHD,PHD, The Unversity of Texas MD Anderson Cancer Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de noviembre de 2024

Finalización primaria (Estimado)

3 de noviembre de 2027

Finalización del estudio (Estimado)

3 de noviembre de 2027

Fechas de registro del estudio

Enviado por primera vez

10 de octubre de 2024

Primero enviado que cumplió con los criterios de control de calidad

10 de octubre de 2024

Publicado por primera vez (Actual)

15 de octubre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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