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Procedure

Spinal Cord Stimulation for Spinal Muscular Atrophy

N/A
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Muscle Weakness Torque
Number and Severity of Adverse Events
Secondary outcome measures
Cortico-spinal Tract Integrity
Discomfort/Pain
Impression
+10 more

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
24 Previous Clinical Trials
3,665 Total Patients Enrolled
Marco CapogrossoLead Sponsor
2 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the criteria to participate in this research endeavor?

"Individuals must have spinal muscular atrophy and be between 16 and 65 years old to qualify for participation in this study. A total of 20 participants will be enrolled in this research trial."

Answered by AI

Are individuals aged 75 and above eligible to participate in this medical study?

"Participants as young as 16 and up to the age of 65 are eligible for enrollment based on the inclusion criteria."

Answered by AI

What is the primary aim of this investigation?

"Additionally, Motor Function Range of Motion (ROM), defined as a meaningful increase above 20% in elbow joint range during SCS-on versus SCS-off"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb
Marco Capogrosso 2024. "Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06300996.
All > Spinal Muscular Atrophy
~13 spots leftby May 2026
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