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NCT00080600 · ClinicalTrials.gov registry record

Brain Physiology in Polio Survivors

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
90
Enrollment target

NCT00080600: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT00080600 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00080600 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
90 participants
Enrollment target

Study Summary

OBJECTIVE: Many persons who survive poliomyelitis develop pain, weakness, and fatigue many decades later. It is not known why some persons develop this syndrome and others do not. One possibility is that polio caused subclinical damage to the motor cortex. Autopsies in some polio patients have found damage to the brainstem and motor cortex as well as to spinal motor neurons. Alternatively, polio may have spared the motor cortex, but the cortex reorganized in different ways to compensate for the loss of spinal motor neurons. This study will first assess the integrity of central motor pathways in polio survivors with and without postpolio syndrome. The second goal will be to investigate differences in the intracortical mechanisms for controlling muscles affected and unaffected by polio. STUDY POPULATION: 60 patients who survived polio in childhood. Only patients with an unequivocal history of polio will be referred to this study. Half of the patients will have the post-polio syndrome. 30 normal volunteers, aged 21-75. DESIGN: Patients will be screened at the collaborating institution, the Uniformed Services University of the Health Sciences, which will also perform sensory evoked potential testing and MRI. At NIH, motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold. Intracortical facilitation will be used to assess using paired-pulse magnetic stimulation. Two muscles will be tested in each patient, one affected by polio and one unaffected by polio. In the affected muscle, intracortical facilitation will be assessed again after exercises it until it fatigues. OUTCOME PARAMETERS: Cortical thresholds and central motor conduction times to all four limbs will be measured in patients and compared to normal subjects. The mean intracortical facilitation at rest will be compared in affected and unaffected muscles in polio patients with and without post-polio syndrome.

Trial Details

FieldValue
Enrollment Target 90 participants
Start Date 2004-04-06
Est. Completion 2007-12-10

What the finished NCT00080600 record still lists

NCT00080600 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT00080600 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00080600 about?

NCT00080600 is a clinical study titled "Brain Physiology in Polio Survivors". OBJECTIVE: Many persons who survive poliomyelitis develop pain, weakness, and fatigue many decades later. It is not known why some persons develop this syndrome and others do not. One possibility is that polio caused subclinical damage to the motor cortex. Autopsies in some polio patients have found...

What is the current status of trial NCT00080600?

This trial is currently completed. The enrollment target is 90 participants. The study started on 2004-04-06. Estimated completion is 2007-12-10.

Who is sponsoring clinical trial NCT00080600?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00080600, the US trial registry maintained by the National Library of Medicine. NCT00080600 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.