Exploring spinal stimulation for treating major depressive disorder
Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains
This study is testing if a new type of spinal stimulation can help people with major depressive disorder feel better by targeting specific pathways in the spine and brain.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Mason, Ohio) |
| Trial ID | NCT06795451 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of spinal interoceptive pathways in major depressive disorder (MDD) by using non-invasive spinal cord stimulation techniques. The research aims to evaluate how transcutaneous spinal direct current stimulation (tsDCS) can modulate these pathways and assess their therapeutic potential. Participants will undergo assessments to measure the engagement of spinal and brain-based pathways, with a focus on determining the optimal stimulation dose. The study employs a phased innovation approach to gather insights into the effectiveness of this novel treatment method.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 60 with a current episode of major depressive disorder who are stable on antidepressant medication.
Not a fit: Patients with treatment-resistant depression or those with a history of bipolar disorder or schizophrenia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients suffering from major depressive disorder.
How similar studies have performed: Preliminary data suggests that targeting spinal interoceptive pathways may be a feasible therapeutic approach, although this specific method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Mason, Ohio
- Lindner Center of Hope — Mason, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Francisco Romo-Nava, MD, PhD — Lindner Center of Hope/ University of Cincinnati
- Study coordinator: Georgi Georgiev
- Email: georgi.georgiev@lindnercenter.org
- Phone: 513-536-0731
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.