NCT06795451 Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
| NCT ID | NCT06795451 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Cincinnati |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 67 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 67 participants in total. It began in 2025-02-25 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Francisco Romo-Nava, MD, PhD
PRINCIPAL INVESTIGATOR
Lindner Center of Hope/ University of Cincinnati
Frequently Asked Questions
Who can join the NCT06795451 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06795451 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06795451 currently recruiting?
Yes, NCT06795451 is actively recruiting participants. Contact the research team at georgi.georgiev@lindnercenter.org for enrollment information.
Where is the NCT06795451 trial being conducted?
This trial is being conducted at Mason, United States.
Who is sponsoring the NCT06795451 clinical trial?
NCT06795451 is sponsored by University of Cincinnati. The principal investigator is Francisco Romo-Nava, MD, PhD at Lindner Center of Hope/ University of Cincinnati. The trial plans to enroll 67 participants.
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