Motor Unit Number Estimation (MUNE) in Adults With Spinal Muscular Atrophy (SMA)

Study Identifier:
2006H0207
ClinicalTrials.gov Identifier:
NCT04139343
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Ohio State University
Study Complete

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Aug 2018 - Dec 2025
    Patient Requirements
    Sex: Female & Male
    Age: 17 - 70 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • 1\. Adults age 17 to 70 with SMA type 2 or 3. The diagnosis of SMA must be documented by the homozygous deletion of both SMN1 genes on standard genetic tests for the disorder, and the determination of type 2 SMA by history of ability to maintain a sitting position when placed, or type 3 by the ability to stand and walk independently. Wheelchair mobile patients will not be excluded from the study.
    • 2\. Interest in participating and the ability to travel to the study site on an agreed upon date on four occasions over a total interval of twenty-four months.
    • 3\. Be in good health with the exception of SMA. Assessments will be rescheduled for a later date in the event of any intercurrent illness that might affect performance on the assessment.
    • Inclusion criteria for control subjects:
    • Healthy adults age 17 to 70
    • Interest in participating and the ability to travel to the study site
    Exclusion Criteria
    • \- Patients unable to tolerate the assessment by virtue of associated medical conditions, respiratory failure with ventilator dependence, or an obligatory need for orthotics that cannot be removed during the evaluation.
    • 2\. Patients who are, in the investigator's opinion, mentally or legally incapacitated, preventing informed consent, or is unable to read and understand written material including the consent 3. Patients with a pacemaker or cardiac device
    • Exclusion criteria for control subjects:
    • Subjects with any neurological disorder
    • Subjects with chronic medical illness that will interfere with their ability to tolerate the study
    • Subjects who are, in the investigator's opinion, mentally or legally incapacitated, preventing informed consent, or is unable to read and understand written material including the consent.

    Protocol Summary

    The primary objective of this research protocol is to study and follow the course of motor neuron loss in individuals with spinal muscular atrophy (SMA) using the electrophysiological technique of motor unit number estimation (MUNE). This study is based on the hypothesis that the electrophysiological technique of motor unit number estimation (MUNE) and compound muscle action potential (CMAP) provide sensitive indicators to assess the severity and progression of disease in adults with SMA.

    Trial Locations

    Location
    Status
    Location
    The Ohio State University Medical Center
    Columbus, Ohio, United States, 43210
    Status
    N/A

    Contact Cure SMA

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