NCT06795451 · University of Cincinnati
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
(MOSPID)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Mason, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations