NIH Clinical Research Studies

Protocol Number: 04-N-0156

Active Accrual, Protocols Recruiting New Patients

Title:
Central Motor Physiology in Polio Survivors
Number:
04-N-0156
Summary:
This study will test whether post-polio syndrome may be due to unrecognized damage to a part of the brain called the motor cortex. Polio is caused by a virus that damages motor neurons in the spinal cord. Most polio survivors recover their strength, but many develop pain, weakness, and fatigue many decades later. It is not known why some people develop this syndrome and others do not. This study will evaluate the integrity of brain pathways in polio survivors with and without post-polio syndrome and in normal volunteers.

Polio survivors between 40 and 75 years of age with or without post-polio syndrome and healthy normal volunteers between 21 and 75 years of age may be eligible for this study. Patients are screened with a medical history, physical examination, magnetic resonance imaging (MRI) scan of the brain, blood tests, and sensory evoked potentials. The MRI uses a powerful magnet, combined with a computer system and radio waves, to produce detailed pictures of the brain. During the scan, the subject lies on a table in a narrow cylinder containing a magnetic field. Sensory evoked potentials measure the excitability of the brain to sensory stimuli. The measurements are obtained from electrodes placed on the scalp.

Participants undergo the following additional procedures:

- Transcranial magnetic stimulation: This procedure maps brain function. A wire coil is held on the scalp, and a brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. During the stimulation, the subject may be asked to tense certain muscles slightly or perform other simple actions to help position the coil properly. The stimulation may cause a twitch in muscles of the face, arm, or leg, and the subject may hear a click and feel a pulling sensation on the skin under the coil. TMS will be done before and after exercise in two muscles (see "Exercise testing" below).

- Nerve conduction study: This test records the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. For this test, small electrical shocks are delivered to the skin of the arms and legs to activate the nerves in these limbs, and the impulses are recorded with electrodes taped to the skin.

- Electromyography: This test measures the electrical activity of muscles to diagnose problems with the nerves or muscles. Electrodes (small metal disks) filled with a conductive gel are taped to the skin to record the activity.

- Exercise testing: This test measures the strongest force the subject can produce in a muscle. The subject's arm or hand is strapped into a device. Each participant contracts the arm muscle with the strongest force possible for several minutes. (A leg may be tested if polio only affected the patient's leg.)

Sponsoring Institute:
National Institute of Neurological Disorders and Stroke (NINDS)
Recruitment Detail
Type: Active Accrual Of New Subjects
Gender: Male & Female
Referral Letter Required: Yes
Population Exclusion(s): Children

Eligibility 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 18 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 40-75 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.

Special Instructions: Currently Not Provided
Keywords:
Post Polio Syndrome
Magnetic Stimulation
Fatigue
Exercise
Weakness
Transcranial Magnetic Stimulation
Post-Exercise Fatigue
Motor Neuron Disease
Cortical Reorganization
Intracortical Facilitation
Recruitment Keywords:
Polio
Post Polio Syndrome
Healthy Volunteer
HV
Conditions:
Postpoliomyelitis
Investigational Drug(s):
None
Investigational Device(s):
None

Contacts:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:
Halstead LS. Assessment and differential diagnosis for post-polio syndrome. Orthopedics. 1991 Nov;14(11):1209-17. No abstract available. PMID: 1758788

Cashman NR, et al. Late denervation in patients with antecedent paralytic poliomyelitis. N Engl J Med. 1987 Jul 2;317(1):7-12. PMID: 3587319

Cashman NR, etc. 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. PMID: 3620621

Active Accrual, Protocols Recruiting New Patients

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