Spinal zaps may unlock new depression treatments
NCT ID NCT06795451
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study explores whether mild electrical stimulation of the spine can change how the brain processes body signals, which may be disrupted in major depression. Researchers will test different stimulation levels in 67 adults with depression to see if it affects brain activity and is well-tolerated. The goal is to understand the role of these pathways in depression and determine if this approach could lead to new treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 67 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Depression - major depressive disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Lindner Center of Hope
RECRUITINGMason, Ohio, 45040, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can brain stimulation rewire how depressed patients learn from rewards?
- Can lay workers in uganda talk depression down?
- Can a computer model outsmart depression in older adults?
- Can a single shot of ketamine calm suicidal distress in the ER?
- Can talk therapy mend more than mood in marital crisis?
- A brain stimulation trial aims to rewire the circuit behind depression