No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
67 (estimated)
Sponsor
University of Cincinnati · Other
Who this trial is looking for
This trial is looking for adults with major depressive disorder to test a new way to help manage their symptoms using a method called spinal cord stimulation. Participants will undergo treatments and complete assessments to see how well the method works.
Are You a Good Fit for This Trial?
Must be takingAntidepressant medication
You may be able to join if
I am between 18 and 60 years old.
I have a current episode of major depressive disorder lasting more than 4 weeks.
I have a body mass index (BMI) between 18.5 and 35.99.
I have a score of 18 or higher on the MADRS at screening.
I have been on a stable dose of an FDA-approved antidepressant for at least 8 weeks.
I can use effective contraception if I can get pregnant.
I am able to complete study-related tasks.
You may not be able to join if
I have not responded to more than two treatment trials for my depression.
I have a current or past diagnosis of bipolar disorder or schizophrenia.
I have had significant suicidal thoughts or behaviors in the past year.
I currently have a substance use disorder.
I have unstable neurological conditions, such as seizure disorders.
I have a history of severe traumatic brain injury or spinal cord injury.
I have unstable medical conditions like uncontrolled high blood pressure.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 stimu…
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.
Trial Locations
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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 the…
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.
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