Spinal zap trial aims to help SMA patients move better
NCT ID NCT05430113
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This small pilot study tested whether a temporary spinal cord stimulator (like a pacemaker for the spine) could help people with spinal muscular atrophy types 3 and 4 move their legs better. Three adults who could stand independently received the implant for up to 29 days. The goal was to see if stimulation increased muscle strength and range of motion without causing serious side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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Apr 2022
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject or subject's parent or legal guardian (for minor subjects) has provided written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, where applicable, prior to any study-related procedures. Minor subjects will be asked to give written assent according to local requirements. 2. Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by determination of a genetic deletion in the SMN1 gene (5q12.2-q13.3) 3. Subject is diagnosed as having Type 3 or Type 4 SMA based on the following criteria 1. Disease manifested after 18 months of age 2. Disease manifested after ambulation was acquired 4. Subject is ≥16 years of age and \< 65 years of age 5. Subject is able to stand independently for ≥3 seconds 6. RHS score lower or equal to 65 7. 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 Exclusion Criteria: 1. Subject has deformation of the spinal canal preventing lead implantation as judged by the study neurosurgeon 2. Subject has size of spinal canal that is insufficient for lead implantation as judged by the study neurosurgeon 3. Subject has moderate or severe joint contractures that would affect ability to perform study measures 4. Subject has severe behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator 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. Female subjects are pregnant or breastfeeding 7. Subject has severe claustrophobia 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. Subject has medical implant that precludes magnetic resonance imaging
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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