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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days for reporting.

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 more

Awards & 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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