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NCT06795451 · ClinicalTrials.gov registry record · Phase 1
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
A Phase 1 study of Depression - Major Depressive Disorder, sponsored by University of Cincinnati.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT06795451 is a Phase 1 study of Depression - Major Depressive Disorder that is actively recruiting participants, run by University of Cincinnati. The registered enrollment target is 67 participants, below the 99-participant average among 19 other Depression - Major Depressive Disorder trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06795451, a Phase 1 study of Depression - Major Depressive Disorder, is actively recruiting participants, sponsored by University of Cincinnati.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DEVICE transcutaneous spinal direct current stimulation
Study Locations (1)
Ohio
- Lindner Center of Hope - Mason
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06795451
The ClinicalTrials.gov registry entry for NCT06795451 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 19 other Depression - Major Depressive Disorder trials with a reported enrollment target (32% lower). The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression - Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which transcutaneous spinal direct current stimulation is the first listed.
NCT06795451 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT06795451 about?
NCT06795451 is a clinical study titled "Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains". 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 ar...
What is the current status of trial NCT06795451?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2025-02-25. Estimated completion is 2026-07-31.
What conditions does trial NCT06795451 study?
This clinical trial studies the following conditions: Depression - Major Depressive Disorder.
What interventions are being tested in trial NCT06795451?
The interventions under investigation include: transcutaneous spinal direct current stimulation (DEVICE).
Who is sponsoring clinical trial NCT06795451?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06795451 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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