NCT00023075

Brief Summary

This study will use a magnetic resonance imaging technique called nuclear magnetic spectroscopy (H-MRS) to define the pathology and progression of primary lateral sclerosis, hereditary spastic paraplegia and amyotrophic lateral sclerosis and assess the usefulness of this technique in evaluating patients' response to therapy. H-MRS will be used to examine metabolic changes in the parts of the brain and spinal cord (motor cortex and corticospinal tract) involved in movement. Normal volunteers and patients with primary lateral sclerosis, hereditary spastic paraplegia or amyotrophic lateral sclerosis between 21 and 65 years of age may be eligible for this study. Participants will have up to five H-MRS studies, including baseline and follow-up tests. For this procedure, the subject lies on a stretcher that is moved into a strong magnetic field. Earplugs are worn to muffle the loud knocking noise that occurs during switching of radio frequencies. The subject will be asked to lie still during each scan, for 1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45 and 90 minutes. Communication with the medical staff is possible at all times during the scan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2001

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 4, 2008

Status Verified

August 1, 2003

First QC Date

August 22, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

MRINeuromuscular DiseaseN-Acetyl AspartateCholineCreatineSpasmsSpasticityPrimary Lateral SclerosisHereditary Spastic ParaplegiaSpastic ParaparesisHealthy VolunteerHVNormal Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with PLS, HSP, and ALS already evaluated by protocol #01-N-0148.
  • Adult normal volunteers

You may not qualify if:

  • Pregnancy, implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except the mouth, intracardiac lines, history of eye shrapnel injury or any other condition/device that may contraindicate or prevent the acquisition of an MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Bonneau D, Rozet JM, Bulteau C, Berthier M, Mettey R, Gil R, Munnich A, Le Merrer M. X linked spastic paraplegia (SPG2): clinical heterogeneity at a single gene locus. J Med Genet. 1993 May;30(5):381-4. doi: 10.1136/jmg.30.5.381.

    PMID: 8320699BACKGROUND
  • Chan S, Shungu DC, Douglas-Akinwande A, Lange DJ, Rowland LP. Motor neuron diseases: comparison of single-voxel proton MR spectroscopy of the motor cortex with MR imaging of the brain. Radiology. 1999 Sep;212(3):763-9. doi: 10.1148/radiology.212.3.r99au35763.

    PMID: 10478245BACKGROUND
  • Comi G, Rovaris M, Leocani L. Review neuroimaging in amyotrophic lateral sclerosis. Eur J Neurol. 1999 Nov;6(6):629-37. doi: 10.1046/j.1468-1331.1999.660629.x.

    PMID: 10529749BACKGROUND

MeSH Terms

Conditions

Motor Neuron DiseaseSpastic Paraplegia, HereditaryAmyotrophic Lateral SclerosisNeuromuscular DiseasesSpasmMuscle SpasticityParaparesis, Spastic

Condition Hierarchy (Ancestors)

Neurodegenerative DiseasesNervous System DiseasesHereditary Sensory and Motor NeuropathyNervous System MalformationsHeredodegenerative Disorders, Nervous SystemPolyneuropathiesPeripheral Nervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornSpinal Cord DiseasesCentral Nervous System DiseasesTDP-43 ProteinopathiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaParaparesisParesis

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 22, 2001

First Posted

August 23, 2001

Study Start

August 1, 2001

Study Completion

August 1, 2003

Last Updated

March 4, 2008

Record last verified: 2003-08

Locations