summary: Researchers conducted a pilot clinical trial showing that spinal cord stimulation (SCS) is a viable and well-tolerated method with the potential to treat major depressive disorder. In this study, 20 patients received her 20-minute SCS sessions three times weekly for 8 weeks.
The results revealed that the group that received positive stimulation had significantly reduced depressive symptom severity compared to the control group. This innovative approach suggests that modulation of brain-body neural pathways through the SCS may have a profound impact on mood regulation, providing a new direction for the treatment of psychiatric disorders. It is something.
Important facts:
- This study showed that spinal cord stimulation is a promising treatment for depression and is well tolerated by patients.
- Participants who received positive stimulation had significantly fewer depressive symptoms.
- This study opens up possibilities for further testing and development of portable SCS devices for the treatment of mental disorders.
sauce: University of Cincinnati
Pilot clinical trial led by University of Cincinnati researchers Lindner Center of Hope Spinal cord electrical stimulation was found to be feasible, well tolerated, and shows promise in the treatment of depression.
The test results were published in a magazine molecular psychiatry December 20th.
Research background
Lead researcher Francisco Romonaba, MD, said his research focuses on how brain-body communication is involved in mental illness.
“We believe that the brain-body connection is essential for mental illness,” says Romonaba, an associate professor in the Department of Psychiatry and Behavioral Neuroscience at the University of California and associate principal investigator at the Lindner Center Research Institute. . HOPE and he are physician-scientists at UC Health.
“Many of the symptoms of mood disorders, eating disorders, and anxiety disorders are associated with what can be interpreted as dysregulation in this brain-body interaction.”
Professor Romonava said neuronal pathways located in the spinal cord convey information from the body to areas of the brain involved in emotional experiences, which we know as moods. When functioning properly, the brain uses this information to constantly make adjustments and regulate a person’s mood.
Major depressive disorder can have many causes, but one contributing factor may be information overload in this pathway.
“Chronic stress, for example, can cause circuits in the brain and body to become overactive, eventually burning out the system and preventing it from regulating in an effective and optimal way,” Romonava said. Ta.
The research team looked at different ways to modulate this interaction between the brain and body and developed a new approach using non-invasive spinal cord stimulation. Romo-Nava patented the stimulation method used in 2020 after working with the University of California Office of Innovation.
Spinal cord stimulation is designed to reduce the flow of information in brain and body circuits, allowing the brain to better recalibrate and regulate itself.
“We believe that spinal cord stimulation helps the brain regulate itself as it should, by reducing noise and reducing the excessive signaling that can occur during depressive syndromes. ” said Professor Romonaba.
The trial device used was about the size of a shoebox, with an active electrode placed on the patient’s back and a return electrode on the right shoulder.
Trial details
Funded through a Brain and Behavior Research Foundation NARSAD Young Investigator Award, Romo-Nava designed a pilot study to test the feasibility and tolerability of spinal cord stimulation in patients with major depressive disorder.
A total of 20 patients were enrolled in the trial, and half were randomized to receive an active version of spinal cord stimulation, and the other half to receive a different version of electrical current that was less likely to be effective.
Patients attended HOPE’s Lindner Center and received three 20-minute sessions per week for eight weeks for a total of 24 spinal stimulation sessions.
Test results
Professor Romonava said that, like most pilot studies, the main focus of this study was the feasibility and safety of the intervention, and how well patients could tolerate the stimulation. The study was designed so that the dose of stimulation could be reduced if needed, but Romonava said all patients tolerated the originally prescribed dose well.
“We used a very small current, about 10 times smaller than currents known to cause tissue damage. This is also very reassuring, as there is a lot to consider when it comes to optimal dose and session frequency. ” he said. .
Side effects of the treatment were mild, including redness of the skin at the stimulation site and a short-term painless itching or burning sensation that lasted only during the treatment session. Romonava said the skin redness usually didn’t last more than 20 minutes after the session.
A virtual reconstruction of how the current from the device flows through the body showed that the current reaches the gray matter of the spinal cord, but not the brain itself.
“This confirms our hypothesis that modulation of these information pathways may cause effects on mood-related regions of the brain,” he said. “In other words, it’s not the electrical current that reaches the brain, but the changes in the signal that have the effect. Although this study is not sufficient to prove all these elements of the hypothesis, we think it is a great start. ”
Patients who received positive stimulation had significantly reduced severity of depressive symptoms compared to the control group, but Professor Romonava cautioned that the study was limited by the small sample size. These results need to be replicated in a larger study to confirm them.
“Due to the pilot nature of this study and small sample size, these results should be interpreted with caution,” he said. “Although the primary results are positive and demonstrate potential for treatment, we need to be aware of all the limitations of the study.”
The data showed that participants’ resting blood pressure did not change over the eight weeks, but their diastolic blood pressure (the lower limit of a blood pressure reading) decreased for a short period of time after each session, cumulatively over the course of the study.
“That may mean that we may actually be causing some kind of plasticity effect in brain-body interaction circuits that are also involved in autonomic functions such as blood pressure and heart rate,” Romonava said. said. “This is very preliminary, but it’s also another signal in the right direction.”
Romonava said the research team is now seeking additional funding to complete extended trials and develop a portable version of the spinal cord stimulator.
If future studies confirm that the stimulation is safe and effective in treating mental illness, future research will also be needed to find the optimal doses, frequencies, and conditions under which the stimulation can be used. .
About this depression research news
author: Tim Tedeschi
sauce: University of Cincinnati
contact: Tim Tedeschi – University of Cincinnati
image: Image credited to Neuroscience News
Original research: Open access.
“Effects of noninvasive spinal cord stimulation in drug-naïve adults with major depressive disorder: A pilot randomized controlled trial and induced current flow patterns.” by Francisco Romo Nava et al. molecular psychiatry
abstract
Effects of noninvasive spinal cord stimulation in drug-naïve adults with major depressive disorder: A pilot randomized controlled trial and induced current flow patterns.
Converging theoretical frameworks suggest a role and therapeutic potential for spinal interoceptive pathways in major depressive disorder (MDD).
Here, we aimed to evaluate the antidepressant efficacy and tolerability of transcutaneous spinal direct current stimulation (tsDCS) in MDD. This was a double-blind, randomized, sham-controlled, parallel-group pilot clinical trial in drug-naive adults with moderate MDD.
20 participants were randomly assigned to receive “active” 2.5 mA or “sham” anodal tsDCS sessions with chest (anodal; T10)/right shoulder (cathode) electrode montage three times per week for 8 weeks (1:1 ratio).
Change in Depression Severity (MADRS) scores (prespecified primary outcome) and secondary clinical outcomes were analyzed using an ANOVA model. The electric field model was generated using active tsDCS parameters. Compared to fake (n= 9), active tsDCS group (n= 10) had a large effect size (-14.6 ± 2.5 vs. -21.7 ± 2.3; p= 0.040, d= 0.86).
Additionally, compared to sham, active tsDCS induced a greater decrease in the MADRS “reported sadness” item (−1.8 ± 0.4 vs. −3.2 ± 0.4, p= 0.012), and the cumulative decrease in diastolic blood pressure change from baseline to endpoint before and after the tsDCS session was greater (between-group difference: 7.9 ± 3.7 mmHg; p= 0.039).
Statistical trends in the same direction were observed for the MADRS “pessimistic thinking” item and the week 8 CGI-I score. No group differences were observed in adverse events (AEs), and no serious AEs occurred.
Current flow simulations showed that electric fields with strengths within the neuromodulatory range (up to ~0.45 V/m) reach the thoracic spinal cord gray matter. The results of this pilot study suggest that tsDCS is feasible and well-tolerated, showing therapeutic potential in MDD.
This study also provides an initial framework for the careful exploration of non-invasive spinal neuromodulation in the context of mental health research and treatment. The underlying mechanisms require further investigation.
Clinicaltrials.gov Registration: NCT03433339