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

April 28, 2026 updated by: Francisco Romo-Nava, University of Cincinnati

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Mason, Ohio, United States, 45040
        • Recruiting
        • Lindner Center of Hope
        • Principal Investigator:
          • Francisco Romo-Nava, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 to 60 yrs., inclusive,
  • Female or Male,

  • With current MDD episode according to MINI 7.0.2. duration (≥4 weeks and

    ≤ 2 yrs.),

  • Current BMI ≥18.5 and ≤ 35.99 kg/mts2
  • MADRS score at screening ≥18
  • Currently on an FDA- approved antidepressant medication at a stable therapeutic dose for ≥ 8 weeks,
  • Psychotherapeutic interventions are allowed if dose/frequency stable for ≥4 weeks,
  • Anxiety disorders allowed if no more than moderate in severity and are not the main diagnosis,
  • Using an effective contraceptive method (participants with childbearing potential), and 10)Able to complete study related tasks.

Exclusion Criteria:

  • Treatment resistance during current depressive episode (>2 treatment trials at adequate doses/duration), including medication and neuromodulation treatments.
  • Current/lifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders.
  • Significant risk of suicide according to CSSRS or clinical judgment, or suicidal behavior in the past year.
  • Psychotic symptoms during the current MDD episode or in the past 6 months.
  • Current (past month) substance use disorder (nicotine, caffeine allowed).
  • Current unstable neurological conditions including seizure disorders (infantile seizures are not exclusionary), neurodegenerative disorders, or stroke.
  • Evidence of severe peripheral neuropathy.
  • History of moderate to severe traumatic brain injury (e.g., skull fracture or loss of consciousness >10 minutes) or spinal cord injury.
  • Unstable clinically significant medical conditions (e.g., uncontrolled hypertension as indicated by a systolic >150 mmHg or diastolic >95mmHg).
  • History of cancer allowed if remitted for the past 5 years.
  • Use of anticonvulsant medications and calcium channel blockers at screening.
  • Current severe pain conditions or need for chronic use of pain medication including NSAIDs and opiates.
  • Implanted electronic medical devices.
  • Neuromodulation interventions in the past month.
  • Active skin lesions on electrode placement sites.
  • pregnant or breastfeeding.
  • Suspected IQ <80.
  • Any other relevant clinical reason as judged by the clinician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 2.0 Sham
Sham will also be compared to "No intervention"
Device: transcutaneous spinal direct current stimulation
transcutaneous spinal direct current stimulation
Active Comparator: 2.5 Active
Device: transcutaneous spinal direct current stimulation
transcutaneous spinal direct current stimulation
Active Comparator: 3.0 Active
Device: transcutaneous spinal direct current stimulation
transcutaneous spinal direct current stimulation
Active Comparator: 3.5 Active
Device: transcutaneous spinal direct current stimulation
transcutaneous spinal direct current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N2 peak amplitude
Time Frame: 5 weeks
Peak amplitude change in N2 expressed in sham to active percentage of change.
5 weeks
N2 latency
Time Frame: 5 weeks
The N2 latency sham to active tsDCS time change in milliseconds (ms)
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Francisco Romo-Nava, MD, PhD, Lindner Center of Hope/ University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 21, 2025

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0510
  • 1R61MH133770-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared according to NIMH Data sharing plan and uploaded to a data repository.

IPD Sharing Time Frame

Upon completion of primary statistical plan and unblinding of data.

IPD Sharing Access Criteria

Deidentified data will be shared on a biorepository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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