Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Functional Neuroimaging and Motor Recovery After Stroke

18 de junio de 2026 actualizado por: University of Delaware

The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke.

This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

14

Fase

  • No aplica

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.

Ubicaciones de estudio

    • Delaware
      • Newark, Delaware, Estados Unidos, 19713
        • Center for Biomedical and Brain Imaging
      • Newark, Delaware, Estados Unidos, 19713
        • STAR Health Sciences Complex

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • age comprised between 35 and 85 years
  • diagnosis of a single unilateral subcortical stroke event occurring more than 6 months prior to enrollment resulting in upper extremity paresis (weakness) of one arm,
  • presence of residual upper extremity motor function, demonstrated by the ability to actively supinate (rotate hand toward "palm-up" direction) the paretic forearm to neutral and to voluntarily extend (bend wrist toward back of the hand) and radially deviate (bend wrist toward thumb side) the paretic wrist at least 5 degrees,
  • adequate cognition to provide informed consent and fully follow instruction (MOCA score of at least 19),
  • English-speaking

Exclusion Criteria:

  • more than 1 stroke,
  • clinical or radiological evidence of damage to the cerebellum or brainstem,
  • contra-indications to MRI (i.e. pacemakers, cochlear implants, neurostimulators, metallic implants, pregnancy, claustrophobia, permanent metal braces, or other implanted devices not approved for 3T imaging - see CBBI MRI Safety Checklist for details),
  • weight >400 pounds and/or unable or too uncomfortable to fit the torso into the MRI bore,
  • musculoskeletal or other neurologic (non-stroke) conditions directly affecting the paretic wrist or hand function (such as tendinitis, arthritis, hand or wrist orthopaedic surgery in the last 6 months, diagnosis of carpal tunnel, multiple sclerosis, Parkinson's disease, etc.)
  • inability to follow instructions on the motor task or understand protocol description (e.g. due to cognitive deficits)
  • participation in additional Occupational or Physical Therapy in which they are doing hand/arm exercises while enrolled in this study
  • received Botox injections in the past 3 months prior to or during participation in the study

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: 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: Conventional Physical Therapy Intervention
The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.
The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity
Periodo de tiempo: Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

The primary outcome is the goodness of fit (R^2) of a regression model relating brain connectivity measures (predictors) to gains in motor function after stroke (clinical measurement).

Predictors: resting-state functional connectivity measured using resting-state fMRI (rs-fMRI). Connectivity is quantified as Fisher-transformed correlation coefficients (z scores, unitless) of signal measured in pairs of regions (edges) within the cortico-thalamic-cerebellar network. Predictors include baseline (pre-task) connectivity and connectivity changes calculated as the difference between post-task and pre-task rs-fMRI measurements.

Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE.

Outcome: model goodness of fit (R^2, unitless). We use a custom LASSO-based variable selection method to construct the final model given multiple predictors and quantify the model fit via R^2.

Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury
Periodo de tiempo: Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

The secondary outcome is the goodness of fit (R^2) of a linear regression model relating corticospinal tract injury (predictor) to gains in motor function after stroke (clinical measurement).

Predictor: percent corticospinal tract injury (%CST injury) quantified using a structural MRI brain scan (FLAIR). The FLAIR image shows the location and volume of lesioned tissue, and %CST injury is quantified as the percentage of CST axon bundles (derived from a previously published healthy template) that overlap with the lesion (predictor units: percent damaged axon bundles).

Clinical measurement: change in Upper Extremity Fugl-Meyer Assessment (FM-UE) score (units: points), calculated as post-intervention FM-UE minus pre-intervention FM-UE.

Outcome: model goodness of fit (R^2, unitless). We use linear regression to relate %CST injury to the change in FM-UE and quantify the model's fit via R^2.

Structural brain scan (FLAIR) is acquired once during the MRI visit at Baseline. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period.

Colaboradores e Investigadores

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

Patrocinador

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)

25 de enero de 2022

Finalización primaria (Actual)

22 de diciembre de 2022

Finalización del estudio (Actual)

22 de diciembre de 2022

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

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

18 de junio de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 1125467
  • 17SDG33690002 (Otro número de subvención/financiamiento: American Heart Association)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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.

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. .

Suscribir