NCT06795451RecruitingPhase 1/2
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
Source: ClinicalTrials.gov · Last updated 3 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 67 (estimated)
- First submitted
- 21 Jan 2025
- Start date
- 25 Feb 2025
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of Cincinnati
- Diseases
- Depression
- NCT number
- NCT06795451
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 67
- From 25 Feb 2025 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment resistance during current depressive episode (\>2 treatment trials at adequate doses/duration), including medication and neuromodulation treatments.
Other illness
- Current/lifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders.
- 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.
- 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.
- Current severe pain conditions or need for chronic use of pain medication including NSAIDs and opiates.
Lab values
- Use of anticonvulsant medications and calcium channel blockers at screening.
Other
- 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.
- Evidence of severe peripheral neuropathy.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lindner Center of Hope Coordinator of this site? Confirm its status | Mason | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.