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NCT06300996 · ClinicalTrials.gov registry record · NA
Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb
A NA study of Spinal Muscular Atrophy and Spinal Muscular Atrophy Type 3, sponsored by Marco Capogrosso.
- Active
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT06300996: Active NA study of Spinal Muscular Atrophy and Spinal Muscular Atrophy Type 3, sponsored by Marco Capogrosso.
NCT06300996 is a NA study of Spinal Muscular Atrophy and Spinal Muscular Atrophy Type 3 that is active but no longer recruiting, run by Marco Capogrosso. The registered enrollment target is 3 participants, below the 109-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06300996, a NA study of Spinal Muscular Atrophy and Spinal Muscular Atrophy Type 3, is active but no longer recruiting, sponsored by Marco Capogrosso.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor deficits in people with Type 2, 3, or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 2, 3, or 4 SMA aged 16 or older that show quantifiable motor deficits of the upper body. The investigators will then implant the subjects with percutaneous, linear spinal leads near the cervical spinal cord for a period of up to 29 days. Although these leads are not optimized for motor function but rather for their clinically approved indication of treating pain, the investigators believe they provide a safe technology enabling our team to perform scientific measurement necessary to evaluate potential for effects of SCS in motor paralysis with SMA. After the end of the study, the leads will be explanted.
Primary Outcome
Isometric torque: measure the isometric torque produced by the subject at the elbow during flexion. The investigators will use the measurement of isometric torque to determine the changes in muscle strength for each participant with SCS on and with SCS off. This comparison will also include testing the non-affected arm to give the investigators a baseline for normal movement of the joint being tested. Success Criteria: ≥30% increased torque production over the SCS-off/non-affected baseline as me
Conditions Studied
Interventions
- DEVICE Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads)
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2029-09 |
| Phase | NA |
What the registry record for NCT06300996 still lists
NCT06300996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 109-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Spinal Muscular Atrophy appearing as the primary indexed condition, and to 1 intervention - of which Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads) is the first listed.
NCT06300996 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06300996 about?
NCT06300996 is a clinical study titled "Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb". Spinal cord stimulation (SCS) has shown remarkable efficacy in restoring motor function in people with spinal cord injury by recruiting afferent input to enhance the responsiveness of spared neural circuits to residual cortical inputs. This pilot will test if SCS can show evidence to improve motor d...
What is the current status of trial NCT06300996?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2024-05-31. Estimated completion is 2029-09.
What conditions does trial NCT06300996 study?
This clinical trial studies the following conditions: Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3, SMA, Spinal Muscular Atrophy Type II, Spinal Muscular Atrophy 4.
What interventions are being tested in trial NCT06300996?
The interventions under investigation include: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads) (DEVICE).
Who is sponsoring clinical trial NCT06300996?
This trial is sponsored by Marco Capogrosso, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06300996 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06300996's enrollment target sits among peer trials
3 23rd of 22 the lowest of 22 other Spinal Muscular Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Muscular Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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