Trial record 8 of 10 for:    "juvenile primary lateral sclerosis" OR "primary lateral sclerosis"

Screening and Natural History: Primary Lateral Sclerosis and Related Disorders

This study is currently recruiting participants.
Verified October 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00015444
First received: April 18, 2001
Last updated: March 14, 2014
Last verified: October 2013
  Purpose

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.


Condition
Motor Nueron Disease
Nervous System Diseases
Muscle Spasticity
Diffusion Tensor Imaging
Disease Progression
Evoked Potentials, Motor/Physiology

Study Type: Observational
Official Title: Screening and Natural History: Primary Lateral Sclerosis and Related Disorders

Resource links provided by NLM:


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

Estimated Enrollment: 240
Study Start Date: April 2001
Detailed 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. 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Age 18 years of age or older

Adult onset of progressive spasticity

No family history of a similar disorder

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00015444

Contacts
Contact: Carol H Hoffman (301) 496-7428 carol.hoffman@nih.gov
Contact: Mary Kay Floeter, M.D. (301) 496-7428 floeterm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Mary Kay Floeter, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00015444     History of Changes
Other Study ID Numbers: 010145, 01-N-0145
Study First Received: April 18, 2001
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
EMG
Spasticity
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Primary Lateral Sclerosis
Muscle Stiffness
Involuntary Muscle Contraction
Isaacs Syndrome

Additional relevant MeSH terms:
Muscle Spasticity
Nervous System Diseases
Sclerosis
Motor Neuron Disease
Disease Progression
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes
Neurodegenerative Diseases
Neuromuscular Diseases
Disease Attributes

ClinicalTrials.gov processed this record on April 17, 2014