Muscle Ultrasound: A New Tool for Measuring Progression in Amyotrophic Lateral Sclerosis (ALS)

NCT00838617 | Completed DMC

• 1 other identifier: 081243
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study in patients with Amyotrophic Lateral Sclerosis (ALS). We will use muscle ultrasound as a tool to try and see if there are changes in muscle size that can find out how fast ALS is progressing. This might give us a better way to carry out further studies on new drugs to see if they might help slow the progression of ALS. Participants in the study will have muscle ultrasound performed on a few muscles in the arms and legs at the first visit, and again 3 months later, and one last time 3 months after that. This takes about 10 minutes, is painless, and involves scanning the muscle with a handheld device, with some gel applied to the skin. At each visit, there will also be a questionnaire about symptoms and strength testing.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis; Ultrasonography; Atrophy

Outcome Measures

Primary Outcomes (1)

• Muscle thickness, as measured by muscle ultrasound, will decrease over time in patients with ALS.

  6 months

Secondary Outcomes (3)

• Muscle thickness, as measured by muscle ultrasound, will correlate with decline in strength testing.

  6 months

• Muscle thickness, as measured by muscle ultrasound, will correlate with decline in the ALS-FRS (ALS Functional Rating Scale) over time.

  6 months

• Muscle echogenicity, as measured by muscle ultrasound, will increase in time, and will correlate with loss of muscle strength.

  6 months

Study Arms (1)

Participants with ALS

Participants diagnosed with ALS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with ALS (Amyotrophic Lateral Sclerosis)

You may qualify if:

• must meet the El Escorial criterion for definite or probable ALS.
• forced vital capacity (FVC) must exceed 50%.

You may not qualify if:

• Patients with primary lateral sclerosis (PLS) and other forms of motor neuron disorders
• severe weakness from ALS who require continuous mechanical ventilation, who have a forced vital capacity less than 50%, or who have no clinically measurable strength in the arms and legs.
• Patients without cognitive capacity to give informed consent. (This is not a clinical feature of ALS, and therefore such patients would have an alternate diagnosis that would prevent such capacity.)

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

ALS Clinic, Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

• Walker FO. Neuromuscular ultrasound. Neurol Clin. 2004 Aug;22(3):563-90, vi. doi: 10.1016/j.ncl.2004.03.004.

  PMID: 15207876 BACKGROUND

• Arts IM, van Rooij FG, Overeem S, Pillen S, Janssen HM, Schelhaas HJ, Zwarts MJ. Quantitative muscle ultrasonography in amyotrophic lateral sclerosis. Ultrasound Med Biol. 2008 Mar;34(3):354-61. doi: 10.1016/j.ultrasmedbio.2007.08.013. Epub 2007 Oct 26.

  PMID: 17964067 BACKGROUND

• Unrath A, Ludolph AC, Kassubek J. Brain metabolites in definite amyotrophic lateral sclerosis. A longitudinal proton magnetic resonance spectroscopy study. J Neurol. 2007 Aug;254(8):1099-106. doi: 10.1007/s00415-006-0495-2. Epub 2007 Apr 13.

  PMID: 17431700 BACKGROUND

• Pillen S, Arts IM, Zwarts MJ. Muscle ultrasound in neuromuscular disorders. Muscle Nerve. 2008 Jun;37(6):679-93. doi: 10.1002/mus.21015.

  PMID: 18506712 BACKGROUND

• Arts IM, Pillen S, Overeem S, Schelhaas HJ, Zwarts MJ. Rise and fall of skeletal muscle size over the entire life span. J Am Geriatr Soc. 2007 Jul;55(7):1150-2. doi: 10.1111/j.1532-5415.2007.01228.x. No abstract available.

  PMID: 17608902 BACKGROUND

• Lacomblez L, Bensimon G, Leigh PN, Guillet P, Meininger V. Dose-ranging study of riluzole in amyotrophic lateral sclerosis. Amyotrophic Lateral Sclerosis/Riluzole Study Group II. Lancet. 1996 May 25;347(9013):1425-31. doi: 10.1016/s0140-6736(96)91680-3.

  PMID: 8676624 BACKGROUND

• Brooks BR, Miller RG, Swash M, Munsat TL; World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Other Motor Neuron Disord. 2000 Dec;1(5):293-9. doi: 10.1080/146608200300079536. No abstract available.

  PMID: 11464847 BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Atrophy

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher D Lee, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter D Donofrio, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 11, 2009

Record last verified: 2009-12

Locations

US (1)