- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05281445
Exploring the Role of Neuroactive Steroids in Tourette Syndrome (NS in TS)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tourette syndrome (TS) is a disabling neurodevelopmental disorder characterized by motor and phonic tics. Available treatment strategies remain unsatisfactory, due to limited knowledge of the biological foundations of this disorder. The studies proposed in this application will explore the mechanisms underlying two of the least well-understood biological characteristics of TS, namely its marked male predominance and stress susceptibility. Studies from the investigators suggest that these features of TS are contributed by neuroactive steroids, a family of mediators implicated in sex and stress regulation.
The typical age of onset of TS is 6-7 years, coinciding with adrenarche, a phase of adrenal maturation characterized by an upsurge in adrenal neuroactive steroids, such as dehydroepiandrosterone (DHEA) and its sulfate (DHEAS). In preliminary studies, the investigators found that DHEA exacerbated tic-like responses in animal models of TS. Interestingly, the dose of DHEA needed to elicit TS-like responses in females is higher than those needed in males, possibly pointing to a mechanism of sex differences in TS.
Stress reduces the ability of TS patients to suppress tics, but the underlying mechanisms remain unknown. Studies in animal models indicate that this process may be due to the elevation of the neuroactive steroid allopregnanolone (AP) in the prefrontal cortex. By inhibiting the ability of the prefrontal cortex to suppress tics, AP promotes tic execution. In a pilot study, the investigators found that tic suppression, a well-known stressful task in TS patients, increases AP salivary levels. Furthermore, in another proof-of-concept study, the investigators found that inhibiting AP synthesis led to a reduction in tic severity and facilitated voluntary control of tics in stressful situations.
These findings lead to the hypothesis that TS patients exhibit alterations of the composition of their neuroactive steroid profiles, including: 1) an increase in baseline DHEA(S) levels in male TS patients, in correlation with life-time severity; and 2) an exaggerated elevation in AP in response to acute stress.
The two Aims of this proposal will test this hypothesis by: 1) comparing the baseline urinary steroidomic profile of TS-affected boys and girls with non-affected sex- and age-matched controls; and 2) charting the dynamic alterations in steroidomic salivary profiles in response to tic suppression. These studies will advance understanding of the endocrine mechanisms in TS and lead to the identification of potential biomarkers for the severity of tics and comorbid symptoms. In the long run, the results of these studies may open the way for the development of new therapies for TS that may reduce tic severity and increase patients' responsiveness to behavioral interventions.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marco Bortolato, MD PhD
- Número de teléfono: 8015873352
- Correo electrónico: marco.bortolato@utah.edu
Copia de seguridad de contactos de estudio
- Nombre: Michael Himle, PhD
- Número de teléfono: 8015817529
- Correo electrónico: michael.himle@utah.edu
Ubicaciones de estudio
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84112
- University of Utah
-
Contacto:
- Michael Himle, PhD
- Número de teléfono: 801-581-7529
- Correo electrónico: michael.himle@utah.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnostic criteria of TS for cases (and lack of any tic disorders for controls)
- Age between 8 and 12 years old (this age range is to ensure that TS participants can perform the tic suppression task)
- confirmation of sexual development by parent and/or self-reported Tanner stage of pubic hair development.
Exclusion Criteria:
- major psychiatric disorders such as a psychotic disorder, autism spectrum disorder, conduct disorder, and substance use disorder;
- other neurological disorders;
- clinically significant endocrinological disorders;
- use of therapies that can modify hormonal profile;
- pharmacotherapies that may change stress sensitivity, such as antidepressants and anxiolytics.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Tic suppression
Children with tics will undergo a tic suppression experimental paradigm.
|
Tic Suppression Task (TST, administered to Tourette syndrome participants only): At the beginning of the task, the child participant will be seated alone in front of a computer monitor with a countdown timer visible on the screen.
For the first 10 minutes (baseline condition) they will be asked to tic freely and not to try to suppress their tics.
For the second 10 minutes children will be asked to suppress their tics and will receive points for successful suppression.
Participants will then be asked to sit alone in the room and tic freely for an additional 10-minutes.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Salivary allopregnanolone concentrations
Periodo de tiempo: Through study completion, an average of 2 years
|
Change of concentrations of salivary allopregnanolone, as measured by chromatography/ mass spectrometry.
All concentrations will be expressed in pg/ml.
|
Through study completion, an average of 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Tic frequency
Periodo de tiempo: Through study completion, an average of 2 years
|
Direct observation
|
Through study completion, an average of 2 years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measurement of salivary concentrations of other neuroactive steroids
Periodo de tiempo: Through study completion, an average of 2 years
|
Changes in concentrations of pregnenolone, 17-hydroxypregnenolone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, androstenediol, progesterone, androstenedione, testosterone, dihydroprogesterone, dihydrotestosterone, isoallopregnanolone, pregnanolone, epipregnanolone, 3-alpha androstanediol, androsterone, epiandrosterone, etiocholanolone, and cortisol as measured by chromatography/ mass spectrometry.
All concentrations will be expressed in pg/ml.
|
Through study completion, an average of 2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marco Bortolato, MD PhD, University of Utah
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- Desordenes mentales
- Procesos Patológicos
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedad
- Enfermedades Genéticas Congénitas
- Enfermedades de los ganglios basales
- Trastornos del movimiento
- Enfermedades neurodegenerativas
- Trastornos Heredodegenerativos, Sistema Nervioso
- Trastornos del neurodesarrollo
- Trastornos de tics
- Síndrome
- Síndrome de Tourette
Otros números de identificación del estudio
- 00150143
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.
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. .