NCT01785550

Brief Summary

Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information. This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

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

February 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

2.1 years

First QC Date

February 5, 2013

Last Update Submit

March 10, 2015

Conditions

ALS

Outcome Measures

Primary Outcomes (1)

  • Abnormalities at onset: Ultrasound vs. Electromyography

    Ultrasound measures will be compared to electromyography measures at the patient's initial assessment. The number of abnormal muscles will be counted using each technique and analyzed to determine if one test is superior.

    1 year

Secondary Outcomes (1)

  • Ultrasound Predicting Outcome at 1 year

    1.5 years

Study Arms (2)

Control Group

No intervention to be performed.

Ultrasound Group

All will receive nerve and muscle ultrasound.

Other: Ultrasound of nerve and muscle

Interventions

Ultrasound of nerve and muscleOTHER

Ultrasound of 6 muscles and 2 nerves will be performed.

Ultrasound Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients referred to the electromyography laboratory for ALS.

You may qualify if:

  • Subjects referred to the electromyography laboratory for ALS.

You may not qualify if:

  • Patients with known comorbid myopathy or neuropathy will be excluded from the study.
  • Patients unable to provide their own consent will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 7, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

US(1)