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Procedure
Spinal Cord Stimulation for Spinal Muscular Atrophy
N/A
Recruiting
Research Sponsored by Marco Capogrosso
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to investigate if spinal cord stimulation can help improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The study will involve en
Who is the study for?
This trial is for individuals aged 16 or older with Type 2, 3, or 4 Spinal Muscular Atrophy (SMA) who have motor deficits in the upper body. Participants will have a spinal cord stimulator implanted temporarily to test if it improves their motor functions.
What is being tested?
The study tests whether a Spinal Cord Stimulator can help improve upper limb motor function in people with SMA Types 2, 3, or 4. Up to six subjects will receive an implant near the cervical spinal cord for up to 29 days.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk from surgery, and possible nerve damage. The device used is typically for pain treatment and not optimized for motor function restoration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 29 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Muscle Weakness Torque
Number and Severity of Adverse Events
Secondary study objectives
Cortico-spinal Tract Integrity
Discomfort/Pain
Impression
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
All patients will receive FDA-approved percutaneous spinal cord stimulation leads implanted in the cervical epidural (C4-T1 vertebra) space. The leads will be connected to external stimulators (either FDA-approved or human-grade research stimulator with safety features) during research activities.
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Who is running the clinical trial?
Roche-GenentechIndustry Sponsor
26 Previous Clinical Trials
3,771 Total Patients Enrolled
Marco CapogrossoLead Sponsor
2 Previous Clinical Trials
18 Total Patients Enrolled