Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Functional Neuroimaging and Motor Recovery After Stroke

18 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Type d'étude

Interventionnel

Inscription (Réel)

14

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Delaware
      • Newark, Delaware, États-Unis, 19713
        • Center for Biomedical and Brain Imaging
      • Newark, Delaware, États-Unis, 19713
        • STAR Health Sciences Complex

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from corticospinal tract injury
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 janvier 2022

Achèvement primaire (Réel)

22 décembre 2022

Achèvement de l'étude (Réel)

22 décembre 2022

Dates d'inscription aux études

Première soumission

5 juin 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

24 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 1125467
  • 17SDG33690002 (Autre subvention/numéro de financement: American Heart Association)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner