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Effect of Stimulus Rate on Cognitive and Motor Activity in Young Subjects, Elderly Subjects, and Patients With Parkinson's Disease

The purpose of this study is to investigate how changes in the brain associated with Parkinson's disease influence the control of motor and thinking speed. There is disagreement over whether patients with Parkinson's disease are slow in thinking as well as movement. This study may provide a new framework to explain the relationship between motor and cognitive aspects of human behavior and help to clarify the pathophysiology of Parkinson's disease.

There are two parts to the study: behavioral tests and functional magnetic resonance imaging (fMRI). All participants will be asked about their medical history, have a physical examination, and complete a questionnaire. They must not take regular medications, including levodopa and dopamine agonists, for 8 hours prior to the study.

The behavioral study involves computer-generated neuropsychological tasks, including hand movements, imagination of movements, and mental calculations. Response will be recorded and evaluated. Electrodes may be placed on the participant's skin to measure surface electromyogram (EMG).

The fMRI study involves MRI scanning in which motor and thinking tasks are performed. Electrodes may be placed on the skin to monitor muscle activity.

Thirty patients, ages 40 and up, with early-stage Parkinson's disease will be recruited. Sixty normal volunteers ages 21-75 will be included as well for comparison.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

A high-level of motor control often requires complex processing of sensory information. Such a cognitive aspect of motor control is supposed to share underlying neural components with non-motor, cognitive operations. The present study is aimed to clarify the similarity and difference between cognitive processing for motor control and non-motor, cognitive processing, especially in terms of the speed of processing. From this standpoint, patients with Parkinson's disease who manifest motor slowing as well as possible cognitive slowing will provide an interesting model to explore similar control mechanisms of speed for motor and non-motor behavioral control. Using psychophysical observations, we will try to clarify normal and diseased control of motor and cognitive speed. Furthermore, using functional magnetic resonance imaging (fMRI), we will explore the neural correlates underlying control of motor and cognitive speed in normal brains as well as pathologic brains. Blood-oxygen-level-dependent signal changes measured by fMRI, as an index of the activity of a neural population, are expected to reveal underactivity or compensatory overactivity in the functionally impaired brain areas responsible for slowing of movement, thinking, or both. This study may provide a new framework to explain the relationship between motor and cognitive aspects of human behavior and help to clarify the pathophysiology of Parkinson's disease.

Studientyp

Beobachtungs

Einschreibung

90

Kontakte und Standorte

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

Studienorte

    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20892
        • National Institute of Neurological Disorders and Stroke (NINDS)

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

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

INCLUSION CRITERIA:

Imaging methods (e.g., structural MRI) may be included as a part of the pre-study evaluation. PD patients should be at a relatively early stage of the disease and must be devoid of any other neuropsychiatric symptoms, especially dementia. To assure this, they are to be rated by UPDRS (motor sub-scale) and standard neuropsychological batteries (e.g., mini-mental test).

Thirty PD patients with age 40 and higher will be recruited. Patients may be male or female. Patients will be asked to withhold any medication that can influence central nervous system (e.g. levodopa) at least 8 hours prior to the examination. They will also asked to abstain from alcohol for 24 hours before the study.

Sixty normal volunteers ranging from 21-75 will be included. Normal volunteers will be recruited from people who are registered as HMCS Normal Volunteers. Patients would be referred from the HMCS Clinic. All subjects participating in MR studies should have a valid Clinical Center Medical Record Number. Procedures for the fMRI experiment will follow the Standard Operating Procedures of the HMCS Neuroimaging group.

EXCLUSION CRITERIA:

PD patients younger than 40 years will be excluded from the study since they are considered to be young-onset PD and have slightly different characteristics from typical idiopathic PD. Normal subjects younger than 21 years old will also be excluded.

Patients with MRI findings consistent with organic brain lesions such as brain tumors, stroke, trauma or AVM's will be excluded.

Patients with progressive neurological disorders other than PD will be excluded.

Patients with a history of significant medical disorders such as cancers, or requiring continuous treatment with drugs other than antiparkinsonian medication, will be excluded.

Subjects who have any contraindications to MRI will be excluded from the fMRI part of the study. We will not scan pregnant women because safety of high magnetic field to fetus is not established. Therefore, we will administer a urine pregnancy test for any female subjects of childbearing potential prior to functional MRI scan.

Patients not capable of giving informed consent will be excluded.

Studienplan

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

Wie ist die Studie aufgebaut?

Mitarbeiter und Ermittler

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

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. Oktober 2001

Studienabschluss

1. November 2003

Studienanmeldedaten

Zuerst eingereicht

10. November 2001

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. November 2001

Zuerst gepostet (Schätzen)

12. November 2001

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

4. März 2008

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. März 2008

Zuletzt verifiziert

1. November 2003

Mehr Informationen

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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