Depression - Major Depressive DisorderPhase 1/2MOSPIDNCT06795451
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
A Phase 1/2 study testing transcutaneous spinal direct current stimulation in people with Depression - Major Depressive Disorder, run by University of Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression - Major Depressive Disorder
- What is being tested?
- transcutaneous spinal direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Mar 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lindner Center of Hope
Mason, Ohio, 45040
Georgi Georgiev, 513-536-0731, georgi.georgiev@lindnercenter.org
Francisco Romo-Nava, MD, PhD
About this study
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
- Being tested
- transcutaneous spinal direct current stimulation
- Keywords
- depression, non-invasive, neuromodulation, spinal stimulation, transcutaneous spinal direct current stimulation, major depressive disorder, interoception, spinal interoceptive pathways, laser-evoked potentials
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous spinal direct current stimulationDevice
transcutaneous spinal direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| 2.0 Sham | Sham comparator | Sham will also be compared to "No intervention" Receives: Device: transcutaneous spinal direct current stimulation |
| 2.5 Active | Active comparator | Not described Receives: Device: transcutaneous spinal direct current stimulation |
| 3.0 Active | Active comparator | Not described Receives: Device: transcutaneous spinal direct current stimulation |
| 3.5 Active | Active comparator | Not described Receives: Device: transcutaneous spinal direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
N2 peak amplitude
Peak amplitude change in N2 expressed in sham to active percentage of change.
Measured: 5 weeks
N2 latency
The N2 latency sham to active tsDCS time change in milliseconds (ms)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Feb 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Francisco Romo-Nava, University of Cincinnati
- Investigators
- Francisco Romo-Nava, MD, PhD, Principal investigator, Lindner Center of Hope/ University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795451
- Sponsor's protocol ID
- 2024-0510
- Other IDs
- 1R61MH133770-01A1
- Acronym
- MOSPID
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared according to NIMH Data sharing plan and uploaded to a data repository.
Publications
Romo-Nava F, Awosika OO, Basu I, Blom TJ, Welge J, Datta A, Guillen A, Guerdjikova AI, Fleck DE, Georgiev G, Mori N, Patino LR, DelBello MP, McNamara RK, Buijs RM, Frye MA, McElroy SL. Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern. Mol Psychiatry. 2024 Mar;29(3):580-589. doi: 10.1038/s41380-023-02349-9. Epub 2023 Dec 20.
PubMed 38123726
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
- ClinicalTrials.gov ID
- NCT06795451
- Acronym / sponsor ID
- MOSPID / 2024-0510
- Conditions
- Depression - Major Depressive Disorder
- Keywords
- depression, non-invasive, neuromodulation, spinal stimulation, transcutaneous spinal direct current stimulation, major depressive disorder, interoception, spinal interoceptive pathways
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2.0 Sham | Sham comparator | Device: transcutaneous spinal direct current stimulationSham will also be compared to "No intervention" |
| 2.5 Active | Active comparator | Device: transcutaneous spinal direct current stimulation |
| 3.0 Active | Active comparator | Device: transcutaneous spinal direct current stimulation |
| 3.5 Active | Active comparator | Device: transcutaneous spinal direct current stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous spinal direct current stimulationtranscutaneous spinal direct current stimulation | Device | 2.0 Sham, 2.5 Active, 3.0 Active, 3.5 Active |
Primary outcome
N2 peak amplitude
Time frame: 5 weeks
Peak amplitude change in N2 expressed in sham to active percentage of change.
N2 latency
Time frame: 5 weeks
The N2 latency sham to active tsDCS time change in milliseconds (ms)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Background: PubMed 38123726Romo-Nava F, Awosika OO, Basu I, Blom TJ, Welge J, Datta A, Guillen A, Guerdjikova AI, Fleck DE, Georgiev G, Mori N, Patino LR, DelBello MP, McNamara RK, Buijs RM, Frye MA, McElroy SL. Effect of non-invasive spinal cord stimulation in unmedicated adults with major depressive disorder: a pilot randomized controlled trial and induced current flow pattern. Mol Psychiatry. 2024 Mar;29(3):580-589. doi: 10.1038/s41380-023-02349-9. Epub 2023 Dec 20.
- Individual participant dataSharing planned: Yes. Data will be shared according to NIMH Data sharing plan and uploaded to a data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Francisco Romo-Nava, MD, PhD principal investigator
Lindner Center of Hope/ University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing transcutaneous spinal direct current stimulation in people with Depression - Major Depressive Disorder, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgi Georgiev (513-536-0731, georgi.georgiev@lindnercenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N2 peak amplitude (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.