Neuromodulation of Executive Control for Substance Use Disorders
TACS fMRI (NEC-TACS)
The purpose of this research study is to determine the effectiveness of a procedure called transcranial alternating current stimulation (tACS) using a device called StarStim cap and its effects on drug cravings.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Participants will undergo a 1-2-day screening that includes a urine drug screen, clinical interview, and self-reporting assessments, once screening is complete, participants will complete a (EEG) recording of your brainwaves. The EEG recording and electrode placement will take about 2 hours. The next portion of the study will involve the use of the StarStim device and an MRI, and you will be asked a series of questions while wearing the device. The day after the MRI scan you will receive a short phone call from study staff. You will be asked to participate in study visits for 2 or 3 days and have 1 follow-up visit. Total study duration for this research study is up to 2 weeks.
The electrical stimulation that the StarStim device uses is considered to be safe, and we are not anticipating any serious side effects. However, mild side effects could include headache, itching and tingling. There are additional risks involved with MRI scans.
You may not receive any personal benefits from being in this study. We hope the information learned from this study will benefit other people with similar conditions in the future.
If you are interested in learning more about this study, please continue to read below. Participating in this research study is voluntary; it is your choice.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Aref Pariz, PhD
- Número de teléfono: 612-624-0134
- Correo electrónico: Aref.Pariz@UTSouthwestern.edu
Copia de seguridad de contactos de estudio
- Nombre: Stephanie Neaves, MRC
- Número de teléfono: 214-648-86044
Ubicaciones de estudio
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Texas
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Dallas, Texas, Estados Unidos, 75235
- UT Southwestern Medical Center
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Able to provide written consent and comply with study procedures.
- Adults aged 18 to 65 years at the time of consent.
- Meets the MINI diagnostic criteria for either methamphetamine use disorder (MUD).
Exclusion Criteria:
- Any contraindications for tACS or MRI scanning (tACS contraindication: history of seizures; potential MRI contraindications, up to the discretion of AIRC and CBH staff: metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder).
- Any medical condition or treatment with neurological sequelae (i.e., stroke, tumor).
- Over 9 months of abstinence from substance use.
- A head injury resulting in a loss of consciousness exceeding 30 minutes (i.e., moderate or severe TBI).
- Presence of a condition that would render study measures difficult or impossible to administer or interpret.
- Entrance to the treatment program under a court mandate. (i.e. legally incarcerated).
- History of ECT or cortical energy exposure within the past 6 months, including participation in any other neuromodulation studies.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Arm 1: Active intervention- tES (transcranial electrical stimulation), then Sham Intervention
tES is considered to be a safe brain stimulation technique that rarely results in adverse events. There is currently no evidence of serious side-effects. Mild side-effects that typically resolve upon discontinuing tACS. The subject may choose to discontinue stimulation at any time during the session if experiencing excessive discomfort or side effects. |
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
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Experimental: Arm 2: Sham intervention, then Active comparator intervention
|
This study involves the use of an investigational device called StarStim. "Investigational" means that the device has not yet been approved by the U.S. Food & Drug Administration (FDA) for helping people recover from drug addiction. This study will help find out what effects, good and/or bad, this device has. The safety of this device in humans has been tested in prior research studies; however, some side effects may not yet be known comparator arm |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brain stimulation and MRI
Periodo de tiempo: Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
Task-dependent functional connectivity measured using psychophysiological interaction (PPI) analysis of blood oxygen level-dependent (BOLD) functional MRI data. PPI regression coefficients quantify differences in connectivity during drug-related versus neutral cues within the executive control network, including the dorsolateral prefrontal cortex and inferior parietal cortex, and between executive control regions and limbic regions, including the ventral striatum and amygdala. Connection-specific PPI coefficients will be reported separately, with within-participant comparisons between active in-phase, active anti-phase, and sham tACS conditions. |
Individual participant data will be analyzed after completion of that participant's study procedures. The final study-level outcome analysis and reporting are planned by study completion, anticipated within one year. This analysis and reporting schedule
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- STU20252588
Información sobre medicamentos y dispositivos, documentos del estudio
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