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Protocol Details

Screening and Natural History: Primary Lateral Sclerosis and Related Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

01-N-0145

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

EMG;
Spasticity;
Motor Neuron Disease;
Amyotrophic Lateral Sclerosis;
Primary Lateral Sclerosis

Recruitment Keyword(s)

Muscle Stiffness;
Involuntary Muscle Contraction;
Spasticity;
Isaacs Syndrome

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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.

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Eligibility

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


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Citations:

Benign nocturnal leg cramps Current controversies over use of quinine

Exercise-induced muscle cramp Proposed mechanisms and management

Diseases associated with excess motor unit activity

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mary Kay Floeter, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10-CRC RM 6-5724
10 CENTER DR
BETHESDA MD 20814
(301) 496-7428
floeterm@ninds.nih.gov

Carol H. Hoffman
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7-5680
10 Center Drive
Bethesda, Maryland 20892
(301) 496-7428
carol.hoffman@nih.gov

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

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00015444

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