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Functional Connectivity Parkinson Disease

31 octobre 2019 mis à jour par: University of Colorado, Denver

Functional Connectivity of the Motor Network in Two Major Subtypes of Parkinson Disease

In this study the investigators are looking at two subtypes of Parkinson Disease (PD); "tremor-dominant" (TD) and postural imbalance and gait disorder (PIGD). This study will use magnet resonance imaging (MRI) to see how the brain reacts while resting and doing a finger-tapping task while on and off PD medication. This study will look at the differences between the two sub-types of PD and healthy volunteers.

The investigators will test the hypothesis that connectivity at rest within the motor cortex and between the motor cortex and motor-associated regions such as the supplementary motor area and the pre motor cortex will not be as strong in PIGD compared to TD (increased activity and functional connectivity in TD group)

Aperçu de l'étude

Statut

Complété

Les conditions

Type d'étude

Observationnel

Inscription (Réel)

86

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

  • États-Unis
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • University of Colorado Denver

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

50 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients with PD according to UK Brain Bank Criteria will be recruited from the UCD Neurology clinic. Controls will be recruited from spouses and from the community

La description

Inclusion Criteria:

  • English as their primary language
  • Patients with Parkinson disease and healthy controls will be enrolled
  • Parkinson patients must be on a dopaminergic medication (levodopa or dopamine agonist) and on a stable dose over the prior month

Exclusion Criteria:

  • If unable to provide informed consent
  • Pregnancy
  • Excess of 300lbs
  • Claustrophobia
  • Metal in body
  • Untreated neurological or psychiatric condition, who are delusional or have hallucinations, with cognitive impairment (MOCA<26), with a history of head injury sufficient to cause a concussion, or with significant systemic medical diseases (e.g. heart failure, liver failure, kidney failure, poorly controlled diabetes, etc.)
  • Healthy control subjects will be excluded if taking any type of dopaminergic or anti-dopaminergic medication
  • Subjects who are unable to demonstrate understanding of the study procedures and risks will be excluded

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

  • Modèles d'observation: Cas-témoins
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Tremor Dominant PD
Volunteers with predominantly tremor-related motor symptoms of PD
Postural Instability & Gait Difficulty PD
Volunteers with primarily walking & balance-related motor symptoms of PD.
Healthy Controls
Healthy volunteers consisting of people of same age as PD volunteers, w/o a diagnosis of PD.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Délai: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Délai: At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
A measure of the correlation coefficients between nodes of the motor network at rest and during a tapping motor task between the "OFF" and "ON" dopaminergic medication states in the two motor subtype PD patients.
At time of 2nd MRI scan: 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Second level contrast between Parkinson Disease (PD) and Healthy Controls (HC).
Délai: At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.
Differences in connectivity as measured by correlation coefficients between nodes of the motor network at rest and during a tapping motor task in PD patients of two motor subtypes and matched healthy controls.
At time of MRI scan: 12 or more hours after their last dose of dopaminergic medication.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Task-related whole-brain activations.
Délai: At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
At time of MRI scan, 12 or more hours after their last dose of dopaminergic medication.
Task-related whole-brain activations.
Délai: At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Secondary outcome measures include task-related whole-brain activations as assessed by changes in blood oxygen-dependent (BOLD) contrast during functional magnetic resonance imaging (fMRI) scanning.
At time of 2nd MRI scan, 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Connectivity between other motor and non-motor brain regions during the tasks.
Délai: At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
Secondary outcome measures include measuring the connectivity between other motor and non-motor brain regions during the tasks.
At time of MRI scan,12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Délai: At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
At time of MRI scan. 12 or more hours after their last dose of dopaminergic medication.
Correlations of brain activity and functional connectivity to structural connectivity measures and behavioral and clinical assessments
Délai: At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).
Secondary outcome measures include a measure of the correlations of brain activity and functional connectivity to structural connectivity measures as well as behavioral and clinical assessments.
At time of 2nd MRI scan. 1 to 3 hours after taking their usual dose(s) dopaminergic medication(s).

Collaborateurs et enquêteurs

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

Parrainer

University of Colorado, Denver

Les enquêteurs

  • Chercheur principal: Brian Berman, MD, MS, University of Colorado, Denver

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

1 juin 2011

Achèvement primaire (Réel)

1 octobre 2017

Achèvement de l'étude (Réel)

1 octobre 2017

Dates d'inscription aux études

Première soumission

11 décembre 2012

Première soumission répondant aux critères de contrôle qualité

21 février 2013

Première publication (Estimation)

26 février 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

31 octobre 2019

Dernière vérification

1 octobre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 10-1311

Plan pour les données individuelles des participants (IPD)

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

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 .

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