Innovative Ultrasound Technology in Neuromuscular Disease (AQUIRe)

Study Purpose:

This study is utilizing ultrasound measurement to measure neuromuscular disease status in adult patients. The hypothesis is the by quantifying ultrasound data, it is possible that ultrasound can be utilized as a tool to determine if a disease is responding to therapy or progressing.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS, Other

Study Type:

Observational Study

Study Category:

Diseases, Study Type, Study Status, Phase, Gender

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Principal Investigator: Seward B Rutkove, MD
Sub-Investigator: Courtney McIlduff, MD

Clinicaltrials.gov ID (11 digit #):

NCT02104921

Neals Affiliated?

No

Coordinating Center Contact Information

Beth Israel Deaconess Medical Center
Carmen Shin; Maria Martucci / .(JavaScript must be enabled to view this email address) / 617-667-3053; 617-667-3053
.(JavaScript must be enabled to view this email address) Boston, Massachusetts 02215 United States

Full Study Summary:

Primary Outcome Measures:
-Quantitative ultrasound data, including quantified grayscale data and backscattered acoustic data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
-Ultrasound data will be collected on multiple muscles in each person. The images will then be quantified using either 1. A grayscale technique in which the images themselves are analyzed via standard image software (e.g., Adobe Photoshop) as to level of echo intensity in a pre-specific region of interest or 2. the raw quantified backscatter data is captured by the transducer, expressed as a unit of power, in the same pre-specified area of interest

Study Sponsor:

Beth Israel Deaconess Medical Center; National Institutes of Health (NIH)

Participant Duration:

Estimated Enrollment:

240

Estimated Study Start Date:

11/30/2013

Estimated Study Completion Date:

11/30/2017

Posting Last Modified Date:

06/30/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • More Information

    https://clinicalt...CT02104921&rank=1

  • Eligibility Criteria

    Gender:

    Male

    Minimum Age:

    21

    Maximum Age:

    80

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


    Study Population

    Patients with any neuromuscular disorder (i.e. primary nerve or muscle disease), both localized and generalized, producing some degree of weakness or disability.
    Criteria

    Inclusion Criteria:
    History of a well-defined, localized or generalized neuromuscular condition producing weakness or muscle atrophy, including disuse atrophy.

    Exclusion Criteria:
    Multiple generalized neuromuscular conditions.

  • Site Contact Information

    Beth Israel Deaconess Medical Center
    Sung Yim; Adam Pacheck / .(JavaScript must be enabled to view this email address) / 617-667-3053; 617-667-3053
    Boston, Massachusetts 02215
    United States