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ReclutandoNCT06578416Registro de ClinicalTrials.gov

The Development of Stuttering in Young Children

Stuttering · Stuttering, Childhood · Stuttering, Developmental

LO ESENCIAL

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio
Observacional
Fase
No aplica / no indicada
Rango de edad
3 años - 6 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
120 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat.

Leer la descripción completa

The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years.

Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, online survey in between visits to the lab (1x each year for up to 5 years). Children will take part in standardized and observational assessments (1x each year for up to 5 years). These may cover aspects of social/emotional development, cognition, and speech, language, and hearing abilities. These tests are used to assess whether a child falls within or outside of the normative range for his/her age.

Children will participate in one or more of the following tasks (1x each year for up to 5 years)

  • Listen to sounds or words and view or name pictures presented on a monitor. Brain activity electroencephalography (EEG) will be recorded while children listen to speech sounds and name pictures. This will be done with an elastic cap that holds special sensors (electrodes). Sensors will also be placed behind each ear, beside each eye, and under the left eye.
  • Virtual reality (VR). Children wear a VR headset and experience virtual, age-appropriate talking situations (e.g., answering questions in a classroom). While they talk in these scenarios, the headset measures where they are looking (eye tracking), and sensors on their forehead, hand, and finger measure their heart rate and sweat response.
  • Children will watch cartoons of animals jumping to a consistent beat (rhythm) and produce a word in time with the animal jumping/beat.
  • Children will repeat nonwords, name pictures, or count while wearing a cap with sensors. Half of the sensors emit light through while the other half measures the reflected light. These sensors give us information about brain activity and are not harmful.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria for controls:

  • English as first/primary language
  • No history of neurological disease
  • Normal or corrected visual acuity
  • No medications expected to affect performance
  • No intellectual impairment, autism spectrum disorder, ADHD
  • Age-appropriate scores on speech and language assessment battery
  • Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally

Inclusion Criteria for children who stutter:

  • English as first/primary language
  • No history of neurological disease
  • Normal or corrected visual acuity
  • No medications expected to affect performance
  • No intellectual impairment or ASD Scores on speech and language assessments indicating stuttering, phonological (speech sound), or language disorders
  • Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally

Población del estudio

Preschool children who do and do not stutter

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No informado
Enmascaramiento
No informado
Children who stutter

Preschool children who stutter aged 3 to 6-years

Diagnostic Test: Standardized assessments of speech and language abilities

Children who do not stutter

Preschool children who do not stutter aged 4 to 6-years

Diagnostic Test: Standardized assessments of speech and language abilities

Standardized assessments of speech and language abilities DIAGNOSTIC_TEST

Standardized and observational assessment of speech and language abilities

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Stuttering Severity

Plazo: 1 x each year for up to 5 years

Assess speech for the presence of stuttering disfluencies and calculate the severity of stuttering based on parent ratings and calculated as the percentage of disfluent syllables out of the total syllables of speech produced.

Virtual reality speaking scenarios

Plazo: 1 x each year for up to 5 years

Record looking events in msec during virtual reality scenarios (classroom of children and kitten)

Virtual reality speaking scenarios

Plazo: 1 x each year for up to 5 years

Pulse oximetry measures will be taken with a photoplethysmograph transducer (Biopac TSD200) secured around the distal phalanx of the fourth finger of the child's non-dominant hand with a Velcro strap. Two measures will be analyzed. (1) Blood pulse volume (BPV) amplitude, the average trough-to-peak amplitude (in volts) of pulse cycles across segments where the child is producing speech and (2) Pulse rate (PR in pulses per minute ppm), will be recorded for each speech segment then averaged. These pulse oximetry measures will be taken during the viewing of virtual reality scenarios (classroom of children and kitten)

Virtual reality speaking scenarios

Plazo: 1 x each year for up to 5 years

Electrodermal (skin conductance) recordings will be collected from the hands while children are immersed in virtual reality speaking scenarios (classroom of children and kitten). We report skin conductance levels and skin conductance response frequency and amplitude in microSiemens (mS).

EEG recording of event-related brain potentials

Plazo: 1 x each year for up to 5 years

Electroencephalographic (EEG) recordings of event-related brain potentials will be conducted during a picture identification task. ERPs will be averaged across conditions and reported in microvolts.

Speech production synchronization

Plazo: 1 x each year for up to 5 years

We record productions of a word spoken to the beat under different feedback conditions. We will assess timing measures reflecting the accuracy with which children synchronize their speech to the beat and retain the rhythm.

fNIRS recording of cortical hemodynamic responses

Plazo: 1 x each year for up to 5 years

Cerebral hemodynamic responses are recorded during the experiment with a continuous-wave fNIRS system (NIRx, Inc). The system uses LED light source optodes, and avalanche photodiode optode detectors for measuring intensity changes in the diffused light at a 10-Hz sampling rate. The optodes are embedded in a standard EEG cap. The concentrations of oxygenated hemoglobin and deoxygenated hemoglobin in micromols will be calculated across trial intervals as participants describe child-friendly picture scenes. These responses will then be averaged across trials for each child.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Developmental Speech LabEast Lansing, Michigan, United StatesReclutando

Equipo y fechas

Patrocinador principal
Michigan State University
Inicio del estudio
1 jun 2023 Real
Finalización primaria
2027-06 Estimado
Finalización del estudio
2027-06 Estimado
Primera publicación
29 ago 2024 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Katelyn Gerwin, Ph.D.CONTACTmsustutteringlab@gmail.com5173553410
Bridget Walsh, Ph.D.CONTACTmsustutteringlab@gmail.com5173553410
Título oficial del estudio

Developmental Trajectories to Stuttering Persistence and Recovery

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026