Overview

This trial is active, not recruiting.

Condition primary lateral sclerosis
Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Start date April 2001
Trial size 189 participants
Trial identifier NCT00015444, 01-N-0145, 010145

Summary

Objective:

The objectives of this protocol are:

to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols,

to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration,

to investigate proposed etiologies, risk factors, and biomarkers for the development of these disorders and for disease progression

Study Population:

240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral sclerosis or related upper motor neuron disorder

Design:

Patients who have been referred by physicians for primary lateral sclerosis will undergo a screening evaluation at the first visit. The screening visit will include review of outside medical records, neurological examination, and diagnostic testing to determine possible causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis by history or examination will be followed to determine the natural history of this disorder. Measures of motor and cognitive function will be made at baseline and follow-up visits to follow clinical progression. Magnetic resonance imaging will be carried out to determine if imaging changes occur over time. Patients identified in this protocol who are eligible for other research protocols will be invited to participate in additional protocols.

Outcome Measures:

Clinical progression will be documented by measures of finger-tapping, timed gait, speech. The association between clinical progression and MRI measures will be assessed as a secondary outcome.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
The primary outcome of this protocol is to document the natural history of clinical progression in PLS, defined as the change in clinical measures of movement speed over time: finger tapping, timed gait, and time to read a standard passage.
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

- INCLUSION CRITERIA: - Age 18 years of age or older - Adult onset of progressive spasticity - No family history of a similar disorder - Able to provide consent or with a legally-authorized representative who can provide consent EXCLUSION CRITERIA: - History of stroke, cerebral palsy, traumatic brain injury or other known etiology of spasticity - Non-neurological disorders producing muscle stiffness, such as fasciitis or rheumatological conditions - Disorders in which pain limits the ability to move muscles, such as fibromyalgia or complex regional pain syndromes - Profound weakness of voluntary movement - Inability to travel to NIH - Anticoagulation will be an exclusion for needle EMG studies - Implanted devices or metal fragments in the brain or spinal cord will be an exclusion for MRI scanning

Additional Information

Official title Screening and Natural History: Primary Lateral Sclerosis and Related Disorders
Principal investigator Mary Kay Floeter, M.D.
Description Objective: The objectives of this protocol are: - to develop and maintain a repository of clinically characterized patients with primary lateral sclerosis for future research protocols, - to characterize the natural history of neurodegenerative disorders with corticospinal neuron degeneration, - to investigate proposed etiologies, risk factors, and biomarkers for the development of these disorders and for disease progression Study Population: 240 patients with adult-onset progressive spasticity with a diagnosis of primary lateral sclerosis or related upper motor neuron disorder Design: Patients who have been referred by physicians for primary lateral sclerosis will undergo a screening evaluation at the first visit. The screening visit will include review of outside medical records, neurological examination, and diagnostic testing to determine possible causes of spasticity. Patients fulfilling the clinical criteria for primary lateral sclerosis by history or examination will be followed to determine the natural history of this disorder. Measures of motor and cognitive function will be made at baseline and follow-up visits to follow clinical progression. Magnetic resonance imaging will be carried out to determine if imaging changes occur over time. Blood samples may be collected for measurement of potential etiologies of PLS, including risk factor genes. Patients identified in this protocol who are eligible for other research protocols will be invited to participate in additional protocols. Outcome Measures: Clinical progression will be documented by measures of finger-tapping, timed gait, speech. The association between clinical progression and MRI measures will be assessed as a secondary outcome.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by National Institutes of Health Clinical Center (CC).