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NCT06300996

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

StatusCompleted
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Sep 2029 to Oct 19, 2026
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 13 to 14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 3
    • Site details revised
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2024 to May 31, 2024
    • Site details revised
    v5
  4. Start date: May 2024 to Sep 2024
    • Primary completion date: May 2026 to Sep 2026
    • Study completion date: May 2029 to Sep 2029
    • Eligibility criteria expanded, about 1 word
    v4
  5. Start date: Mar 13, 2024 to May 2024
    • Primary completion date: Mar 13, 2026 to May 2026
    • Study completion date: Mar 13, 2029 to May 2029
    v3
  6. Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 13 entries
    v2
  7. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number and Severity of Adverse Events
Timeframe: 29 days

Secondary (14)

Muscle Weakness Muscle Activation
Motor Function ROM
Motor Function RULM
Motor Function Fatigue
Discomfort/Pain
Show 9 moreShow less
Sensorimotor Network Structure Density
Impression
Sensorimotor Network Structure Integrity
Sensorimotor Network Function
Cortico-spinal Tract Integrity
Spinal Circuit Excitability
Motoneuron Firing Rates
Motor Firing Number
Muscle Weakness Torque

Arms and interventions

Spinal Cord StimulationExperimental

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.

Devices: Spinal Cord Stimulator (Octopolar Medtronic Vectris Leads)

Sites

1 site in 1 country

  • University of PittsburghPittsburgh, Pennsylvania, United States