- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05916417
Dosificación personalizada TMS-fNIRS
The intent of this study is to establish technical feasibility in a clinical population (PTSD, with or without mild TBI) of personalized TMS-fNIRS technology. Thereby demonstrating the utility of transcranial magnetic stimulation - functional near-infrared spectroscopy (TMS-fNIRS) technology as a direct measure of frontal brain activity, potentially replacing the indirect motor threshold procedure that may lead to improper dosing of TMS.
Personalized TMS-fNIRS technology will guide therapy for depression, post-traumatic stress disorder (PTSD), and/or traumatic brain injury (TBI)
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tallahassee, Florida, Estados Unidos, 32306
- Isabelle Taylor
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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
- Adults ages 18-70 years.
- Eligible for consideration of treatment with TMS for PTSD.
- Diagnosis of PTSD based on CAPS-5.
- No changes in psychotropic medication (if taking psychotropic medication) and/or changes in supportive psychotherapy for 1 month prior to initial visit; and clinically appropriate to maintain stable treatment regimen for duration of study.
- Clinically competent to give informed written consent and ability to understand study procedures and to comply with them for the entire length of the study
Exclusion Criteria:
- Medical contraindication for neuromodulation (e.g., ferrous metal in head, seizure disorder, brain tumor, stroke, aneurysm, multiple sclerosis, etc.).
- Unable to have an MRI (e.g., due to ferrous metal or inability to tolerate).
- Active substance use disorder in last 3 months or any current substance use that puts the participant at increased risk or significant impairment
- Dementia or other cognitive disorder making unable to engage in study.
- Any history or diagnosis of Schizophrenia, Schizoaffective Disorder, Delusional Disorder or other psychotic illness.
- Suicidal risk that precludes safe participation defined as clinical impression that the participant is at significant risk for suicide.
- OCD cannot be the primary disorder but can have OCD symptoms
- Taking any medication that significantly lowers the seizure threshold (e.g., tricyclic antidepressants, clozapine, etc.)
- Current, planned, or suspected pregnancy
- Unstable medical conditions or any current medical condition that could preclude being able to safely participate in TMS treatment (e.g., unstable metabolic abnormality, unstable angina, etc.)
- Severe Traumatic Brain Injury
- Prior TMS treatment or already received TMS as part of a study.
- Significant ongoing litigation or claims that impact research activities, as determined by the research study team. (Research may especially be impacted when mental health or pain is being evaluated for litigation or claims, such as civil and criminal cases, disability claims and worker's compensation).
We will exclude non-English speakers because of the need for rapid communication during the testing.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: TMS-fNIRS over the dl-PFC (Active)
TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light. |
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Comparador falso: TMS-fNIRS over the dl-PFC (Sham)
TMS-fNIRS dl-PFC data will be acquired with participants being randomized to active or sham stimulation of the dl-PFC, with the randomizing of the order of four different TMS-fNIRS protocols. |
Transcranial Magnetic Stimulation (TMS) is a non-invasive brain stimulation technology. Functional Near Infrared Spectroscopy (fNIRS) is a brain imaging technology that utilizes light. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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TMS induced Brain changes as measured by functional Near Infrared Spectroscopy (fNIRS) comparing Motor Cortex (MC) and Dorsolateral Prefrontal Cortex (dl-PFC)
Periodo de tiempo: Months 3-33
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The magnitude of brain activation based on fNIRS signal for the respective cortices at the individual level will be assessed and compared for the MC and dl-PFC. |
Months 3-33
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Frank A Kozel, M.D., M.S.C.R., D.F.A.P.A., Florida State University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
- Trastornos relacionados con el trauma y el estrés
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Lesiones Cerebrales
- Trastornos de Estrés, Traumáticos
- Lesiones Cerebrales Traumáticas
- Trastornos de estrés postraumático
Otros números de identificación del estudio
- STUDY00004007
- CDMRP-TP220192 (Otro número de subvención/financiamiento: Department of Defense)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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