Spinal Cord Stimulator (octopolar Medtronic Vectris Leads) for Atrophy

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pittsburgh, Pittsburgh, PA
Atrophy+4 More
Spinal Cord Stimulator (octopolar Medtronic Vectris Leads) - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

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 3 or 4 spinal muscular atrophy (SMA). The investigators will enroll up to six subjects with Type 3 or 4 SMA aged 16 or older that show quantifiable motor deficits of the legs but are able to stand independently. The investigators will then implant the subjects with percutaneous, bilateral, linear spinal leads near the lumbar 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.

Eligible Conditions

  • Atrophy
  • Type 3 Spinal Muscular Atrophy
  • Spinal Muscular Atrophy Type 4

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Atrophy

Study Objectives

2 Primary · 14 Secondary · Reporting Duration: 29 days

29 days
Cortico-spinal Tract Integrity
Discomfort/Pain
Impression
Motoneuron Firing Rates
Motor Firing Number
Motor Function RHS
Motor Function ROM
Motor Function: 6-Minute Walk Teset
Motor Function: Fatigue
Muscle Weakness
Muscle Weakness 2
Number and Severity of Adverse Events
Sensorimotor Network Function
Sensorimotor Network Structure Density
Sensorimotor Network Structure Integrity
Spinal Circuit Excitability

Trial Safety

Safety Progress

1 of 3

Other trials for Atrophy

Trial Design

1 Treatment Group

Spinal Cord Stimulation
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Spinal Cord Stimulator (octopolar Medtronic Vectris Leads) · No Placebo Group · N/A

Spinal Cord Stimulation
Device
Experimental Group · 1 Intervention: Spinal Cord Stimulator (octopolar Medtronic Vectris Leads) · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 29 days
Closest Location: University of Pittsburgh · Pittsburgh, PA
Photo of University of Pittsburgh Medical Center   1Photo of University of Pittsburgh Medical Center   2Photo of University of Pittsburgh Medical Center  3
2004First Recorded Clinical Trial
3 TrialsResearching Atrophy
646 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient has a diagnosis of Type 3 or Type 4 SMA.
You have disease manifested after ambulation was acquired.
You are willing and able to comply with scheduled visits and study procedures.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.