Recruiting
Phase 1
Phase 2

tsDCS

Sponsor:

University of Cincinnati

Code:

NCT06795451

Conditions

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

transcutaneous spinal direct current stimulation

Study Details

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.

Conditions

Depression - Major Depressive Disorder

Study ID

NCT06795451

Start date

Feb 25, 2025

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

67 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: 2.0 Sham

Sham will also be compared to "No intervention"

active comparator: 2.5 Active

active comparator: 3.0 Active

active comparator: 3.5 Active

Interventions

transcutaneous spinal direct current stimulation

transcutaneous spinal direct current stimulation

Primary outcome measure

  • N2 peak amplitude [ Time Frame: 5 weeks ]
  • N2 latency [ Time Frame: 5 weeks ]

Central Contacts and Locations

Central contacts

Georgi Georgiev

513-536-0731georgi.georgiev@lindnercenter.org

Locations

Lindner Center of Hope

Recruiting

Mason, Ohio, United States, 45040

Contacts

Georgi Georgiev

513-536-0731georgi.georgiev@lindnercenter.org

Principal Investigator:

Francisco Romo-Nava, MD, PhD

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • depression
  • non-invasive
  • neuromodulation
  • spinal stimulation
  • transcutaneous spinal direct current stimulation
  • major depressive disorder
  • interoception
  • spinal interoceptive pathways
  • laser-evoked potentials

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-08-03.