Brain Physiology in Polio Survivors

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00080600
First received: April 7, 2004
Last updated: March 5, 2008
Last verified: December 2007
  Purpose

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.


Condition
Postpoliomyelitis

Study Type: Observational
Official Title: Central Motor Physiology in Polio Survivors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 90
Study Start Date: April 2004
Estimated Study Completion Date: December 2007
Detailed Description:

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 21-80.

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. At NIH, motor evoked potentials will be elicited from all four limbs using transcranial magnetic stimulation to assess central motor conduction time and threshold. MRI scans of the brain or spine will be performed in patients with abnormal evoked potentials. Intracortical facilitation will be assessed 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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

POLIO PATIENTS:

Complete screening evaluation.

Meet clinical criteria for diagnosis of past polio (see below).

Meet clinical criteria for the diagnosis of PPS (PPS group only) and have new muscle weakness.

Age 21 or older.

CLINICAL CRITERIA FOR PAST POLIO (CONFIRMED):

Clinically compatible signs and symptoms of paralytic poliomyelitis (acute flaccid paralysis of one or more limbs).

Decreased or absent tendon reflexes on the affected limbs.

No persistent sensory or cognitive loss.

No other apparent cause (including laboratory investigation to rule out other causes of similar syndrome).

Neurological deficit present 60 days after onset of initial symptoms.

Associated with isolation of either vaccine or wild poliovirus from a clinical specimen.

CLINICAL CRITERIA FOR POST-POLIO SYNDROME:

History of polio with partial or complete neurological and functional recovery.

Stable function greater than 15 years.

New onset of one or more of the following: fatigue, weakness, atrophy, muscle pain, functional loss.

Exclusion of other explanations for the symptomatology.

Neurological evaluation demonstrating: lower motor neuron dysfunction (confirmed by EMG, imaging studies or muscle biopsy), no sensory loss.

Must have new onset of muscle weakness in one or more limb muscles, as determined by history and clinical examination.

NORMAL VOLUNTEERS:

Healthy adult volunteers ages 21-80 who are willing to participate.

EXCLUSION CRITERIA:

Neurological diseases or conditions, other than polio, that in the judgment of the investigators may account for the symptoms or interfere with the experimental interventions.

Implanted devices, such as pumps, pacemakers, or metal fragments in the skull or eye.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080600

Locations
United States, Maryland
Uniformed Services University of the Health Sciences
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00080600     History of Changes
Other Study ID Numbers: 040156, 04-N-0156
Study First Received: April 7, 2004
Last Updated: March 5, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Post Polio Syndrome
Magnetic Stimulation
Fatigue
Exercise
Weakness
Transcranial Magnetic Stimulation
Post-Exercise Fatigue
Motor Neuron Disease
Cortical Reorganization
Intracortical Facilitation
Polio
Healthy Volunteer
HV

Additional relevant MeSH terms:
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on July 22, 2014