Exploring spinal stimulation for treating major depressive disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.