PostpoliomyelitisNCT00080600
Brain Physiology in Polio Survivors
An observational study of Postpoliomyelitis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postpoliomyelitis
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2004to 10 Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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):
Show all 16Show fewer
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Uniformed Services University of the Health Sciences
Bethesda, Maryland, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Central Motor 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 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.
Read more
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.
Read the 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.
- Conditions
- Postpoliomyelitis
- Keywords
- 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
- Medical subject headings
- Postpoliomyelitis Syndrome, Fatigue, Motor Activity, Asthenia, Motor Neuron Disease, Poliomyelitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2004 (estimated)
- Study start6 Apr 2004
- Study completion10 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PostpoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080600
- Sponsor's protocol ID
- 040156
- Other IDs
- 04-N-0156
- Status last verified
- 10 Dec 2007
- First submitted
- 7 Apr 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Cashman NR, Maselli R, Wollmann RL, Roos R, Simon R, Antel JP. Post-poliomyelitis syndrome: evidence of ongoing denervation in symptomatic and asymptomatic patients. Birth Defects Orig Artic Ser. 1987;23(4):237-9. No abstract available.
PubMed 3620621Prokhorenko OA, Vasconcelos OM, Lupu VD, Campbell WW, Jabbari B. Sensory physiology assessed by evoked potentials in survivors of poliomyelitis. Muscle Nerve. 2008 Oct;38(4):1266-71. doi: 10.1002/mus.21093.
PubMed 18816600Lupu VD, Danielian L, Johnsen JA, Vasconcelos OM, Prokhorenko OA, Jabbari B, Campbell WW, Floeter MK. Physiology of the motor cortex in polio survivors. Muscle Nerve. 2008 Feb;37(2):177-82. doi: 10.1002/mus.20913.
PubMed 17990291
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Motor Physiology in Polio Survivors
- ClinicalTrials.gov ID
- NCT00080600
- Acronym / sponsor ID
- 040156
- Conditions
- Postpoliomyelitis
- Keywords
- Post Polio Syndrome, Magnetic Stimulation, Fatigue, Exercise, Weakness, Transcranial Magnetic Stimulation, Post-Exercise Fatigue, Motor Neuron Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 6 Apr 2004
- Study completion
- 10 Dec 2007
- First posted
- 7 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- Clinically compatible signs and symptoms of paralytic poliomyelitis (acute flaccid paralysis of one or more limbs).
Key exclusion criteria (6 listed)
- 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.
- Healthy adult volunteers ages 21-80 who are willing to participate.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 3620621Cashman NR, Maselli R, Wollmann RL, Roos R, Simon R, Antel JP. Post-poliomyelitis syndrome: evidence of ongoing denervation in symptomatic and asymptomatic patients. Birth Defects Orig Artic Ser. 1987;23(4):237-9. No abstract available.
- Derived from this study: PubMed 18816600Prokhorenko OA, Vasconcelos OM, Lupu VD, Campbell WW, Jabbari B. Sensory physiology assessed by evoked potentials in survivors of poliomyelitis. Muscle Nerve. 2008 Oct;38(4):1266-71. doi: 10.1002/mus.21093.
- Derived from this study: PubMed 17990291Lupu VD, Danielian L, Johnsen JA, Vasconcelos OM, Prokhorenko OA, Jabbari B, Campbell WW, Floeter MK. Physiology of the motor cortex in polio survivors. Muscle Nerve. 2008 Feb;37(2):177-82. doi: 10.1002/mus.20913.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpoliomyelitis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080600, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.