NCT06839469 Establishing Walking-related Digital Biomarkers in Rare Childhood Onset Progressive Neuromuscular Disorders
| NCT ID | NCT06839469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Spinal Muscular Atrophy Type 3 |
| Study Type | OBSERVATIONAL |
| Enrollment | 106 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 106 participants in total. It began in 2024-05-01 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this research is (1) to identify disease specific walking-related digital biomarkers of disease severity, and (2) monitor longitudinal changes in natural environments, for extended periods of time, in DMD and SMA.
Eligibility Criteria
Inclusion Criteria: * Genetic confirmation of disease (DMD, SMA) or healthy control * Able to walk independently at least 25 meters * Ongoing corticosteroids therapy or initiation of corticosteroid therapy in the previous 3 months for DMD * Stable dose of FDA approved SMN up-regulator therapy or in an open-label extension phase of a study treatment for at least 6 months for SMA or gene replacement at enrollment for SMA or DMD participants. Exclusion Criteria: * Use foot orthoses or assistive devices for community ambulation or a mobility device for community navigation * Use investigational medications intended for treatment of NMD within 30 days * Prior to study entry had an injury or surgery that would impact gait within the previous 3 months
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06839469 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Spinal Muscular Atrophy Type 3. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06839469 currently recruiting?
Yes, NCT06839469 is actively recruiting participants. Contact the research team at jm598@cumc.columbia.edu for enrollment information.
Where is the NCT06839469 trial being conducted?
This trial is being conducted at Palo Alto, United States, Boston, United States, New York, United States.
Who is sponsoring the NCT06839469 clinical trial?
NCT06839469 is sponsored by Columbia University. The trial plans to enroll 106 participants.