LCOH-UC study: Spinal cord stimulation a potential new way to treat depression

Lindner Center of HOPE, UC researcher publishes pilot study showing feasibility of method

A pilot clinical trial led by Lindner Center of HOPE Research Institute and University of Cincinnati researchers at the Lindner Center of HOPE found electrical stimulation of the spinal cord is feasible, well-tolerated, and shows therapeutic potential to treat depression.

The results of the trial were published in the journal Molecular Psychiatry on Dec. 20. View link at https://rdcu.be/dt41x

Research background

Principal investigator Francisco Romo-Nava, MD, PhD, said his research focuses on how brain-body communication is involved in psychiatric disorders.

“We think that the connection between the brain and the body is essential for psychiatric disorders,” said Romo-Nava, Associate Chief Research Officer for the Research Institute at the Lindner Center of HOPE, Associate Professor in the Department of Psychiatry and Behavioral Neurosciences at UC, and a UC Health physician scientist. “Many of the symptoms of mood disorders or eating disorders or anxiety disorders have to do with what one could interpret as dysregulation in this brain-body interaction.”

Romo-Nava said pathways of neurons located in the spinal cord convey information from the body to regions of the brain that are involved in the emotional experience we know as mood. When functioning properly, the brain uses this information to constantly make adjustments to help regulate a person’s mood.

While major depressive disorder can have many different causes, one contributor could be this pathway being overloaded with information.

“For example, chronic stress could lead to a hyperactive brain-body circuit that eventually burns the system out and prevents it from adjusting itself in an effective and optimal way,” Romo-Nava said.

The research team looked at different ways to modulate this interaction between the brain and body and developed a novel approach through non-invasive spinal cord stimulation. Romo-Nava received a patent for the device obtained a patent in 2020 for the stimulation method used after working with UC’s Office of Innovation.

The spinal cord stimulation is designed to decrease the flow of information in the brain-body circuit so that the brain is better able to readjust and regulate itself.

“Spinal cord stimulation is thought to help the brain modulate itself as it should by decreasing the noise or decreasing the hyperactive signaling that may be in place during a depressive syndrome,” Romo-Nava said.

The investigational device that was used is no larger than a shoe box, with the active electrode placed on the patient’s back and the return electrode placed on their right shoulder.

Trial details

With funding through a Brain & Behavior Research Foundation NARSAD Young Investigator Award, Romo-Nava designed the pilot study to test the feasibility and tolerability of spinal cord stimulation for patients with major depressive disorder.

A total of 20 patients were enrolled in the trial, with half randomized to receive the active version of the spinal cord stimulation and half receiving a different version of current that was not expected to have much of an effect.

Patients went to the Lindner Center of HOPE for three 20-minute sessions a week for eight weeks, for a total of 24 spinal stimulation sessions.

Trial results

Romo-Nava said like with most pilot studies, the primary focus of the study was the feasibility and safety of the intervention and how well patients tolerated the stimulation. The study was designed so that the dose of stimulation could be decreased if needed, but Romo-Nava said all patients tolerated the initially prescribed dose well.

“We used a current that is so small that it’s about 10 times smaller than the one known to induce tissue damage, so that’s also pretty encouraging because there’s a lot to explore in terms of what is the optimal dose and session frequency,” he said.

Side effects of the treatment were mild, including skin redness at the site of stimulation and brief non-painful itching or burning sensations that only lasted during the treatment sessions. The skin redness typically did not last more than 20 minutes after a session, Romo-Nava said.

A virtual reconstruction of how the current from the device moves through the body showed the current reaches spinal gray matter in the spinal cord, but does not reach the brain itself.

“That supports our hypothesis that it is the modulation of these pathways of information that then may induce an effect on the mood-relevant areas in the brain,” he said. “So it is not the current that reaches the brain, it is the change in the signal that then has an effect. This study is not sufficient to prove all of these components of the hypothesis, but we think it’s a great start.”

Patients that received the active stimulation had a greater decrease in the severity of their depressive symptoms compared to the control group, but Romo-Nava cautioned the study was limited by its small sample size. These results will need to be replicated in much larger studies to be confirmed.

“We need to be cautious when we interpret these results because of the pilot nature and the small sample size of the study,” he said. “While the primary outcome was positive and it shows therapeutic potential, we should acknowledge all the limitations of the study.”

Data showed participants’ resting blood pressure did not change over the course of the eight weeks, but their diastolic blood pressure (the bottom number of a blood pressure reading) decreased for a short time after each session in a cumulative way during the study.

“That may mean that we may be actually inducing a form of plastic effect on the brain-body interaction circuit that is also involved in autonomic functions like blood pressure and heart rate,” Romo-Nava said. “This is very preliminary, but it is also another signal that is in the right direction.”

Moving forward, Romo-Nava said the research team is seeking additional funding to put together an expanded trial and develop a portable version of the spinal cord stimulation device. If further studies confirm the stimulation is safe and effective to treat psychiatric disorders, future work will also be needed to find the optimal dose, frequency and conditions it can be used for.

 

Lindner Center of HOPE  provides excellent, patient-centered, scientifically advanced care for individuals suffering with mental illness. A state-of-the-science mental-health center and charter member of the National Network of Depression Centers, the center provides psychiatric hospitalization and partial hospitalization for adults, outpatient services for all ages, diagnostic and short-term residential services for adults, intensive outpatient program for substance abuse and co-occurring disorders for adults and research. The center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The center is also affiliated with the University of Cincinnati (UC) College of Medicine.

 

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Sue McElroy

Mason, OH, February 22, 2023 – Lindner Center of HOPE, Chief Research Officer, Susan L. McElroy, MD, was recently named to the Research.com “Best Female Scientists in the United States 2022 Ranking” for her contributions to the advancement of science.

This was the first edition of the Research.com ranking of top female scientists in the United States and was based upon data collected from Microsoft Academic Graph. Position in the ranking is based on a scientist’s general H-index. The inclusion criteria for scholars to be considered into the global ranking of top scientists are based on the H-index, proportion of the contributions made within the given discipline in addition to the awards and achievements of the scientists. Only top 1000 female scientists with the highest H-index are featured in the ranking. Nearly 167,000 scientists were examined for the ranking.

Dr. McElroy is internationally known for her research in bipolar disorder, eating disorders, obesity, impulse control disorders and pharmacology. She is the author of over 600 scientific papers in leading medical journals and was the 8th most cited scientist in the world published in the fields of psychiatry and psychology since 1996. She has also authored over 150 reviews and chapters in major psychiatric textbooks. Dr. McElroy is the editor or author of 4 scientific books and serves on the editorial boards of 5 journals.

As Chief Research Officer she currently oversees multiple ongoing studies in mood, anxiety, eating and impulse control disorders, genetics and psychopharmacology.

The UNESCO Institute for Statistics (UIS) estimates that less than 30 percent of the world’s researchers are women.

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Lindner Center of HOPE in Mason is a comprehensive mental health center providing excellent, patient-centered, scientifically-advanced care for individuals suffering with mental illness. A state-of-the-science, mental health center and charter member of the National Network of Depression Centers, the Center provides psychiatric hospitalization and partial hospitalization for individuals age 12-years-old and older, outpatient services for all ages, diagnostic and short-term residential services for adults and adolescents, outpatient services and research. The Center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The Center is also affiliated with the University of Cincinnati (UC) College of Medicine.

 

Lindner Center of HOPE Chief Research Officer member of team that identifies 64 regions of the genome that increase risk for bipolar disorder

Mason, OH, April 22, 2021 – Chief Research Officer of The Research Institute at Lindner Center of HOPE, Susan McElroy, MD, was part of a research team in the largest genetic study of bipolar disorder to date.  In his genetic study researchers have identified 64 regions of the genome containing DNA variations that increase risk of bipolar disorder—more than double the number previously identified.

The research team also found overlap in the genetic bases of bipolar disorder and other psychiatric disorders. Furthermore, the study supports a role of sleep habits, alcohol, and substance usage in the development of bipolar disorder, although further research is needed to confirm these findings. The study results were published May 17 in Nature Genetics (https://www.nature.com/articles/s41588-021-00857-4). Read the full press release at https://medicalxpress.com/news/2021-05-regions-genome-bipolar-disorder.html .

 

A UC, Lindner Center of HOPE study investigates the role of the circadian clock in obesity and eating behavior

The clocks on our walls, on the lock screens of our phones and attached to our wrists drive most actions in our lives. Time determines when we have to go to bed or wake up in the morning, when we need to be in class or at work and even when we feel the need to eat breakfast, lunch or dinner.

We also have inner, cellular clocks in most tissues of our body that are coordinated by a master circadian clock in the brain. These clocks form our circadian system that triggers some of these needs and responses, like getting tired and feeling hunger.

Now, researchers at the University of Cincinnati and the Lindner Center of HOPE are hosting a unique clinical trial to see if readjusting the circadian system of people with binge eating behavior can help in understanding more about why this occurs and develop new treatment options in the future. Scientists are using tabletop lamps and melatonin supplements to test their theory.

Binge eating behavior is a form of disordered eating characterized by excessive food consumption with a loss of control, causing a person to overeat in a relatively short period of time.

The associated Binge Eating Disorder, or BED, is characterized by recurrent episodes, without the compensatory behaviors observed in bulimia nervosa, meaning purging afterward. BED is the most prevalent eating disorder worldwide and affects an estimated 2.8 million people in the United States. It is frequently observed in individuals with obesity and those with other psychiatric diagnoses, like mood and anxiety disorders. Many are unaware that they have BED, and it remains undiagnosed. Additionally, treatment options are very limited.

Francisco Romo-Nava, MD, PhD, an assistant professor in the Department of Psychiatry and Behavioral Neurosciences at UC, associate chief research officer for the Research Institute at the Lindner Center of HOPE and a UC Health physician scientist, says little is known about how the circadian system in these patients impacts their eating patterns.

Francisco Romo-Nava Psychiatry

“The circadian system makes it possible for our body to adapt to day and night periods, which has profound effects on physiology and behavior beyond regulation of sleep and wake cycles,” he says. “The most powerful signals that synchronize our circadian system are the presence of daylight and the production of melatonin at night, which is the chemical signal of darkness.

“The circadian system is different for each person. For example, some people work better during the day while others do so at night. Some people skip breakfast, while others eat a large meal to start the day. Recent studies suggest that the circadian system may be involved in regulating our food choices, the time at which we eat and how much we eat. However, the involvement of the circadian system in disordered eating behavior, such as binge eating behavior, is not well understood.”

Romo-Nava says preliminary research has shown that those with binge eating disorder may have circadian system abnormalities, and that by targeting this system in the body, new interventions and treatments may be available for patients.

In this study, funded by the National Institute of Mental Health and housed at UC’s Lindner Center of HOPE, researchers will compare the circadian system function in 80 adults with obesity, 40 with binge eating disorder and 40 without, for two weeks. Participants will complete a sleep and eating behavior diary and wear a device — a watch — that measures activity patterns.

Their circadian phases will be assessed by determining surges in melatonin concentrations at the specific point in time when their brains and bodies shift into “night mode.”

Romo-Nava says, traditionally, studies such as this involved costly and inconvenient in-hospital or sleep lab assessments of melatonin concentrations in saliva samples under dim lights, mimicking dusk, to detect the time of the surge in melatonin production at night.

However, in this study, researchers are using a new approach, where participants can collect the saliva samples easily at home in a dimly lit room.   

Finally, researchers will test whether or not they can resynchronize study participants’ circadian system over the course of a month by combining morning light, mimicked by tabletop lamps, and the administration of a fixed dose of melatonin or placebo at night. The melatonin is given at times that are individualized according to each participants’ circadian phase. This phase of the study will only be conducted on individuals who have been diagnosed with binge eating disorder.

“We want to evaluate if this method can be an individualized way to study the circadian system in this condition,” Romo-Nava says. “But ultimately, we want to advance our understanding of the role of the circadian system in binge eating disorder, and this study will provide valuable insight on its potential as a new therapeutic target. We’re excited about how this could positively impact patients with binge eating disorder in the future.”

More about the study

Participants without binge eating will be paid up to $215 for completing four study visits that involve assessments and laboratory studies. Participants with BED will be paid up to $440 for completing study procedures, which also include an intervention study phase and a total of eight study visits. Payments will be made at the end of each study visit with a prepaid debit card. For more information, contact Brian or George at (513) 536-0707 or fill out a prescreening questionnaire.

Francisco Romo-Nava, M.D., Ph.D., Associate Chief Research Officer, Research Institute at Lindner Center of HOPE, has been distinguished as a 2021 International Society for Bipolar Disorders (ISBD) Best Poster Awardee, for his poster Revisiting the Bipolar Disorder with Migraine phenotype: Clinical Features and Comorbidity. His poster is the effort of the team at The Research Institute. The program committee reviewed almost 200 posters, and Dr. Romo-Nava’s was rated among the highest. The best poster awardees will be recognized with a ribbon on the poster image in the poster gallery, listed in the General Conference Information and will also be acknowledged in the email that will be sent out to all registered attendees to launch the poster session each day.

This is the ISBD’s 23rd annual conference. It is a global conference taking place via interactive platform May 13-15, 2021.

Lindner Center of HOPE in Mason is a comprehensive mental health center providing excellent, patient-centered, scientifically-advanced care for individuals suffering with mental illness. A state-of-the-science, mental health center and charter member of the National Network of Depression Centers, the Center provides psychiatric hospitalization and partial hospitalization for individuals age 12-years-old and older, outpatient services for all ages, diagnostic services for all ages and short-term residential services for adults, and research. The Center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The Center is also affiliated with the University of Cincinnati (UC) College of Medicine.

As a community member, you are invited to complete a community-wide health survey for the 2021 Community Health Needs Assessment (CHNA). The 2021 CHNA is sponsored by The Health Collaborative (THC) and Generation Health (Gen-H), who are working in partnership with the Greater Dayton Area Hospital Association, as well as multiple health partners throughout the 39-hospital, 25-county Greater Cincinnati region, which includes southwest Ohio (including the Greater Dayton Area), southeast Indiana and northern Kentucky.

This online survey will ask basic questions about your health, what makes being healthy easy or hard, and how our community is supporting your health. The information we collect will inform how we will direct our energy and resources to meet the complex healthcare needs of the community and will inspire innovative healthcare delivery models designed to unite our region-wide efforts in providing high-quality care, increasing access to care, and achieving improved health outcomes for all.

The online survey will be open from April 1 to May 30, 2021, and is available in American Sign Language (ASL), Arabic, English, French, Nepali, and Spanish. All respondents will remain anonymous. At the end of this survey, you will be able to enter a drawing for one of two $100 Amazon gift cards.

If you live in the Greater Cincinnati or Dayton Area, please complete our online health survey. Here is the link to the survey: https://genh.healthcollab.org/

Paper surveys can be made available upon request. Please contact Elizabeth Pafford by sending an email to epafford@measurementresourcesco.com to request paper copies of the survey, or for help with any technical issues you experience with the online survey.

For more general questions about the 2021 Community Health Needs Assessment (CHNA), please contact Lauren Bartoszek by sending an email to lbartoszek@healthcollab.org, or calling 513-247-6860.

Office of Innovation at University of Cincinnati Supported Utility Patent Process for this Method to Modulate Brain-Body Communication

Francisco Romo-Nava, M.D., Ph.D., Associate Chief Research Officer for The Research Institute at Lindner Center of HOPE and Assistant Professor for the Department of Psychiatry and Behavioral Neurosciences at the University of Cincinnati (UC) College of Medicine, has been awarded a United States patent for transcutaneous spinal cord stimulation for the purpose of treating psychiatric disorders. The Office of Innovation at University of Cincinnati supported the utility patent process for this method to modulate brain-body communication in the context of psychiatric disorders.

The utility patent will aid in the advancement of grant proposals for testing the use of this method in treating psychiatric disorders, allowing for concept expansion, the possibility of private company collaboration to further develop the method, and potential funding for the development of technology for delivering the treatment for public good.

Romo-Nava has been exploring a novel “Neuroscience of the Body” research approach that considers psychiatric disorders not only affect the brain, but also the body. Likewise, the body also affects the brain.

In 2018, The Research Institute at Lindner Center of HOPE launched a pilot study specifically looking at the communication between the brain and the body and the role spinal pathways play in the origins of psychiatric disorders. The hypothesis is that the communication between the brain and the body is disturbed in patients with Major Depressive Disorder (and other psychiatric disorders) which contributes to depressive symptoms and consequently may contribute to elevate the risk of medical comorbidity. Though this area needs additional study, it has been gaining focus as it explains why a patient with a psychiatric disorder might also have more physical illness.

The study, which is ongoing, is looking at the impact of non-invasive spinal stimulation for the treatment of Major Depressive Disorder. The team is testing an exclusively investigational device to apply a small electrical current through the skin to modulate spinal pathways and modify the disturbed communication between the brain and the body. The patent will protect the idea of modulating the spinal cord function for the purposes of treating psychiatric disorders with UC as assignee.

“We are proposing that by modulating spinal cord function we can have an effect on the psychiatric disorder. We are gathering these data to give us a signal of how to develop new methods to treat depression and, ideally, expand to other psychiatric disorders,” said Romo-Nava.

Romo-Nava received the 2017 Young Investigator Award from the National Alliance for Research in Schizophrenia and Depression (NARSAD) granted by the Brain and Behavior Research Foundation for this study. Dr. Romo-Nava is also currently funded by a NIMH K23 Career Development Award.

The study is currently recruiting participants between the ages of 18 and 55 who are currently moderately depressed for at least one month and not currently on medication for the treatment of depression. Participants would be required to complete a phone screening, attend a screening visit that includes labs and other tests, attend a baseline visit and attend 20-minute stimulation sessions three times per week for eight weeks. Eligible participants will be compensated up to $250 for their time and travel. A pre-screening questionnaire, as well as more information on this and other studies conducted at the Lindner Center of HOPE Research Institute can be found at www.LCOH.info.

 

Lindner Center of HOPE  provides excellent, patient-centered, scientifically advanced care for individuals suffering with mental illness. A state-of-the-science mental-health center and charter member of the National Network of Depression Centers, the center provides psychiatric hospitalization and partial hospitalization for individuals 12 years and older, outpatient services for all ages, diagnostic and short-term residential services for adults and adolescents, intensive outpatient program for substance abuse and co-occurring disorders for adults and research. The center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The center is also affiliated with the University of Cincinnati (UC) College of Medicine.

 

Professor Susan McElroy of the Lindner Center of HOPE leads a group researching potential new medications for BN and BED. As part of this work, Professor McElroy and her colleagues Anna Guerdjikova, Nicole Mori and Francesco Romo-Nava recently investigated the potential of existing drugs in treating binge eating conditions.”

 

Read their latest findings and learn more about the important need for identifying new binge eating medications: http://cdn.researchoutreach.org/Flipbooks/RO118/index.html#  pages 74-77.

 

National Institute of Mental Health Acknowledges Dr. Romo-Nava with Highly Coveted Award

Dr. Francisco Romo-Nava, MD, PhD

Mason, OH –The National Institute of Mental Health (NIMH) awarded a K23 Career Development Award titled “The role of the circadian system in binge eating disorder” to Dr. Francisco Romo-Nava, MD, PhD, Associate Chief Research Officer at The Research Institute at Lindner Center of HOPE. This is a highly competitive award for clinician-scientists that will enable the development of the “Neuroscience of the Body Research Program” to study the role of brain-body communication in psychiatric disorders.

This K-23 award involves a study with a novel approach to investigate the circadian system function and its’ potential as a therapeutic target in binge eating disorder. During this award, Dr. Romo-Nava will receive mentoring by world renowned researchers. Dr. Susan L. McElroy, Chief Research Officer at The Research Institute at Lindner Center of HOPE, will mentor Dr. Romo-Nava during the award period. Dr. Romo-Nava will also receive mentoring by Dr. Carlos Grilo at Yale University, Dr. Frank Scheer at Harvard University, Dr. Robert McNamara and Dr. Jeffrey Welge at the University of Cincinnati. Dr. Romo-Nava will also collaborate with Dr. Helen Burgess at the University of Michigan.

This award involves an estimated budget of $810,000 during the next four years.

Lindner Center of HOPE in Mason is a comprehensive mental health center providing excellent, patient-centered, scientifically-advanced care for individuals suffering with mental illness. A state-of-the-science, mental health center and charter member of the National Network of Depression Centers, the Center provides psychiatric hospitalization and partial hospitalization for individuals age 12-years-old and older, outpatient services for all ages, diagnostic services for all ages and short-term residential services for adults, outpatient services for substance abuse through HOPE Center North location and co-occurring disorders for adults and research. The Center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The Center is also affiliated with the University of Cincinnati (UC) College of Medicine.

 

Study Evaluating Spinal Stimulation in the Treatment of Major Depressive Disorder

The Research Institute at Lindner Center of HOPE is exploring a novel “Neuroscience of the Body” research approach that considers psychiatric disorders not only affect the brain, but also the body. Likewise, the body also affects the brain. A current study specifically looks at the communication between the brain and the body and the role the spinal pathways play in the origins of psychiatric disorders. The hypothesis is that the communication between the brain and the body is disturbed in patients with Major Depressive Disorder which contributes to depressive symptoms and consequently may elevate the risk of medical comorbidity.

The study, led by investigators at The Research Institute at Lindner Center of HOPE, is looking at the impact of non-invasive spinal stimulation for the treatment of Major Depressive Disorder. The team is testing an exclusively investigational device to apply a small electrical current through the skin to modulate spinal pathways and modify the disturbed communication between the brain and the body.

The study is currently recruiting participants between the ages of 18 and 50 who are currently moderately depressed for at least one month and not currently on medication for the treatment of depression. Participants would be required to complete a phone screening, attend a screening visit that includes labs and other tests, attend a baseline visit and attend 20-minute stimulation sessions three times per week for eight weeks. Eligible participants will be compensated up to $250 for their time and travel.

The Research Institute at Lindner Center of HOPE’s Associate Chief Research Officer, Francisco Romo-Nava, MD, PhD, received the 2017 Young Investigator Award from the National Alliance for Research in Schizophrenia and Depression (NARSAD) granted by the Brain and Behavior Foundation for this study.

“It is an honor to receive this prestigious award for the most promising young investigators developing neuroscience research in the field of mental health,” said Romo-Nava. “This is a world-wide competition that funds the most innovative ideas for research for all sorts of psychiatric disorders.”

Lindner Center of HOPE  provides excellent, patient-centered, scientifically advanced care for individuals suffering with mental illness. A state-of-the-science mental-health center and charter member of the National Network of Depression Centers, the center provides psychiatric hospitalization and partial hospitalization for individuals 12 years and older, outpatient services for all ages, diagnostic and short-term residential services for adults and adolescents, intensive outpatient program for substance abuse and co-occurring disorders for adults and research. The center is enhanced by its partnership with UC Health as its clinicians are ranked among the best providers locally, nationally and internationally. Together Lindner Center of HOPE and UC Health offer a true system of mental health care in the Greater Cincinnati area and across the country. The center is also affiliated with the University of Cincinnati (UC) College of Medicine.