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Mechanisms of Stimulation for Pain Alleviation

Study acronym: M-SPA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 2 words
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Primary completion date: Jan 1, 2028 to Aug 2028
    • Start date changed from estimate of Jan 1, 2025 to Sep 26, 2025
    • Primary endpoint revised
    • Enrollment target: 134 to 148
    • Study completion date: Jan 1, 2028 to Nov 1, 2028
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoint revised
    • Site details revised
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the upper extremities, lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.
Trial Details
NCT Number NCT06741579
Lead Sponsor Stanford University
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS), University of Kansas Medical Center
Conditions
(from sponsor)		 Peripheral Nerve Stimulation, Chronic Neuropathic Pain, Chronic Neuropathic Pain (Below the Shoulders)
Enrollment 148 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov