Status:
ACTIVE_NOT_RECRUITING
Motor Unit Number Estimation (MUNE) in Adults With Spinal Muscular Atrophy (SMA)
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
Cure SMA
Conditions:
Spinal Muscular Atrophy
Eligibility:
All Genders
17-70 years
Brief 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 mot...
Detailed Description
This is a prospective pilot study to determine MUNE and CMAP values in a population of adults with SMA, assess how these electrophysiologic parameters change over time, and explore how well these para...
Eligibility Criteria
Inclusion
- 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
- \- 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.
Key Trial Info
Start Date :
August 10 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04139343
Start Date
August 10 2018
End Date
December 31 2025
Last Update
December 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210