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Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains

Study acronym: MOSPID
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jul 31, 2026 → Mar 31, 2027
See other at-risk trials from University of Cincinnati

Record History

  1. Primary and study completion pushed from Jul 31, 2026 to Mar 31, 2027v8
  2. Eligibility criteria shortened, about 1 wordv7 See this version in full on ClinicalTrials.gov ↗
  3. Start date: Feb 17, 2025 to Feb 25, 2025v6
  4. Phase: Not applicable to Phase 1/2 Primary and study completion dates: Jul 2026 to Jul 31, 2026v5 Show 1 more changeShow less
    • Primary and study completion dates: Jul 2026 to Jul 31, 2026
  5. Start date changed from estimate of Feb 2025 to Feb 17, 2025 Site contact updatedv4 Show 1 more changeShow less
    • Site contact updated
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  1. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 2025 to Feb 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Jan 2025 to Feb 2025
    • Site details revised
  2. Eligibility criteria shortened, about 10 wordsv2 See this version in full on ClinicalTrials.gov ↗
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Spinal interoceptive pathways (SIPs) convey bodily signals to an interoceptive system in the brain and their dysregulation is linked to major depressive disorder (MDD). Current treatments are partially effective and the role of SIPs in MDD is vastly unexplored. Preliminary data suggests that SIPs are feasible therapeutic targets in MDD. The central hypothesis is that non-invasive spinal cord stimulation will modulate SIPs to elucidate their role and therapeutic potential in MDD using an R61/33 phased innovation approach. R61 phase specific aims (SA). The specific goal will be to evaluate spinal and brain-based SIPs target engagement markers of transcutaneous spinal direct current stimulation (tsDCS) in MDD with two SAs: SA1) To determine tsDCS SIPs modulation using laser-evoked potentials (LEPs) as electroencephalography (EEG)- based neural measures of target engagement. SA2) To evaluate optimal tsDCS dose based upon tolerability and SIPs target engagement markers. Anodal tsDCS will be evaluated as a tool to modulate SIPs in MDD. SIPs (Aδ and C fibers) can be evaluated via LEPs as neural measures (EEG) elicited in MDD-relevant brain regions within an interoceptive system. Prior data shows anodal tsDCS inhibits SIPs and LEPs N2 component will be assessed as tsDCS engagement markers. Adults with MDD (n=67) will participate in a double-blind, crossover, sham-controlled study to evaluate tsDCS at 0,2.5,3, and 3.5 mA. The working hypothesis is that tsDCS will induce a change in LEPs (SA1) in a dose-dependent and tolerable manner (SA2), supporting their use as SIPs engagement markers. Go/No-Go milestones: Compared to sham, the active tsDCS dose that induces a change in LEPs at a preestablished threshold will be evidence of SIPs engagement and "Go" criteria for the R33 phase.
Trial Details
NCT Number NCT06795451
Lead Sponsor University of Cincinnati
Collaborators: National Institute of Mental Health (NIMH)
Conditions Depression - Major Depressive Disorder
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov