Actively Recruiting
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
Led by University of Cincinnati · Updated on 2026-05-04
67
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
Sponsors
U
University of Cincinnati
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years inclusive
- Female or male
- Current major depressive disorder episode lasting at least 4 weeks and no more than 2 years according to MINI 7.0.2
- Body mass index (BMI) between 18.5 and 35.99 kg/m2
- Montgomery-Åsberg Depression Rating Scale (MADRS) score of 18 or higher at screening
- On a stable therapeutic dose of FDA-approved antidepressant medication for at least 8 weeks
- Stable psychotherapeutic interventions for at least 4 weeks allowed
- Anxiety disorders allowed if not the main diagnosis and no more than moderate severity
- Using an effective contraceptive method if of childbearing potential
- Able to complete study-related tasks
You will not qualify if you...
- Treatment resistance during current depressive episode with more than 2 treatment trials at adequate doses and duration
- Current or lifetime diagnosis of bipolar disorder or schizophrenia spectrum disorders
- Significant suicide risk or suicidal behavior in the past year
- Psychotic symptoms during current episode or in past 6 months
- Current substance use disorder except nicotine or caffeine
- Unstable neurological conditions including seizure disorders, neurodegenerative disorders, or stroke
- Severe peripheral neuropathy
- History of moderate to severe traumatic brain injury or spinal cord injury
- Unstable clinically significant medical conditions such as uncontrolled hypertension
- History of cancer unless in remission for past 5 years
- Use of anticonvulsants or calcium channel blockers at screening
- Severe pain conditions or chronic use of pain medications including NSAIDs and opiates
- Implanted electronic medical devices
- Neuromodulation treatments in past month
- Active skin lesions at electrode placement sites
- Pregnant or breastfeeding
- Suspected IQ less than 80
- Any other clinical reason judged by the clinician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Lindner Center of Hope
Mason, Ohio, United States, 45040
Actively Recruiting
Research Team
G
Georgi Georgiev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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