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Functional Connectivity Parkinson Disease

31. Oktober 2019 aktualisiert von: 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)

Studienübersicht

Status

Abgeschlossen

Bedingungen

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

86

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University of Colorado Denver

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Fallkontrolle
  • Zeitperspektiven: Interessent

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Correlation coefficients between nodes of the motor network at rest and during a tapping motor task.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Task-related whole-brain activations.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Colorado, Denver

Ermittler

  • Hauptermittler: Brian Berman, MD, MS, University of Colorado, Denver

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2011

Primärer Abschluss (Tatsächlich)

1. Oktober 2017

Studienabschluss (Tatsächlich)

1. Oktober 2017

Studienanmeldedaten

Zuerst eingereicht

11. Dezember 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Februar 2013

Zuerst gepostet (Schätzen)

26. Februar 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. November 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Oktober 2019

Zuletzt verifiziert

1. Oktober 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 10-1311

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

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