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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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição

90

Contactos e Locais

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Locais de estudo

    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institute of Neurological Disorders and Stroke (NINDS)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

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Como o estudo é projetado?

Colaboradores e Investigadores

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de outubro de 2001

Conclusão do estudo

1 de novembro de 2003

Datas de inscrição no estudo

Enviado pela primeira vez

10 de novembro de 2001

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de novembro de 2001

Primeira postagem (Estimativa)

12 de novembro de 2001

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de março de 2008

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de março de 2008

Última verificação

1 de novembro de 2003

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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