ACTIVE_NOT_RECRUITING

Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb

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Conditions

Spinal Muscular AtrophySpinal Muscular Atrophy Type 3Spinal Muscular Atrophy Type IISpinal Muscular Atrophy 4SMASpinal Cord Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Spinal Cord Stimulation for the Treatment of Motor Deficits in People With Spinal Muscular Atrophy - Upper Limb Protocol

Quick Facts

Study Start:2024-05-31
Study Completion:2029-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06300996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by determination of a genetic deletion in the SMN1 gene (5q12.2-q13.3).
  2. 2. Subject is diagnosed as being non-ambulatory SMA based on the following criteria:
  3. 3. Subject is ≥16 years of age and \< 65 years of age.
  4. 4. Subject is able to sit independently.
  5. 5. A minimum score of 1 for Entry Item "A" of the Revised Upper Limb Module (RULM) scale for SMA: "Can use hands to hold pencil or pick up a coin/token or drive a powered chair, use phone key pad"
  6. 6. Subject (and subject's parent or legal guardian if subject is a minor) is willing and able to comply with scheduled visits and study procedures
  7. 7. Participants must have started SMN inducing therapies (Spinraza or risdisplam) at least 6 months prior to enrollment. (They must have either gotten their first injection at at least 6 months prior, or they started daily intake of risdisplam at least 6 months prior to the study)
  1. 1. Subject has deformation of the spinal canal preventing lead implantation as judged by the study neurosurgeon
  2. 2. Subject has size of spinal canal that is insufficient for lead implantation as judged by the study neurosurgeon
  3. 3. Subject has moderate or severe joint contractures that would affect ability to perform study measures, determined by the study physician
  4. 4. Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator
  5. 5. Subject has previous or ongoing medical condition, medical history, physical findings or laboratory abnormalities that could affect safety of anesthesia or the procedures, make it unlikely that intervention or follow-up will be correctly completed or impair the assessment of study results, in the opinion of the investigator
  6. 6. Female subjects are pregnant or breastfeeding, as established by self-report.
  7. 7. Subject has severe claustrophobia
  8. 8. Subject is on anticoagulant, anti-spasticity or anti-seizure medication within 4 weeks of lead implantation or requires these medications during the treatment phase of the study
  9. 9. Subject has medical implant that precludes magnetic resonance imaging
  10. 10. Subject has a deconditioned respiratory system, per the discretion of the physician investigator.
  11. 11. Subjects with renal insufficiency at the discretion of the physician investigator.
  12. 12. Subjects requiring any form of sedation for MRI will be excluded.

Contacts and Locations

Principal Investigator

Marco Capogrosso
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Marco Capogrosso

  • Marco Capogrosso, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-31
Study Completion Date2029-09

Study Record Updates

Study Start Date2024-05-31
Study Completion Date2029-09

Terms related to this study

Keywords Provided by Researchers

  • Spinal Cord Stimulation

Additional Relevant MeSH Terms

  • Spinal Muscular Atrophy
  • Spinal Muscular Atrophy Type 3
  • Spinal Muscular Atrophy Type II
  • Spinal Muscular Atrophy 4
  • SMA