Soterix Medical Inc. announces today the BETTER trial for bipolar depression. Bipolar depression (BD) is a prevalent condition, with poor therapeutic options and a high degree of refractoriness. This justifies the development of novel treatment strategies, such as transcranial direct current stimulation (tDCS) with Limited Total Energy (tDCS-LTE) that showed promising results in clinical trials of unipolar depression. In the BETTER trial, sixty patients will be enrolled and assessed with clinical and neuropsychological tests in a randomized, sham-controlled, double-blinded trial using tDCS for refractory, acutely symptomatic BD (the bipolar depression electrical treatment trial, BETTER). The primary outcome is change (over time and across groups) in the scores of the Hamilton Depression Rating Scale (17 items). Biological markers such as blood neurotrophins and interleukins, genetic polymorphisms, heart rate variability, and motor cortical excitability will be assessed. Twelve anodal-left / cathodal-right 2mA tDCS-LTE sessions over the dorsolateral prefrontal cortex will be performed in 6 weeks. This landmark upcoming clinical trial will address the efficacy of tDCS-LTE for BD on different degrees of refractoriness. The evaluation of biological markers will also help in understanding the pathophysiology of BD and the mechanisms of action of tDCS. More trial information is available here.
Dr. Abhishek Datta, CTO at Soterix Medical summarizes “The BETTER neuromodulation study is noteworthy for its focus on bipolar depression. The most rigorous tDCS clinical trials, including two separate ongoing multi-center trials on Depression (ClinicalTrials.gov Identifier: NCT01562184 and NCT01894815) are using the Soterix Medical 1x1-CT platform with our exclusive LTE technology”. Dr. John Smith, Scientist at Soterix Medical further added “It is expected that once again world-class investigators chose Soterix Medical’s groundbreaking Transcranial Direct Current Stimulation Limited Total Energy (tDCS-LTE) and unique EASYstrap platform head-gear. The Soterix Medical tDCS-LTE platform is the only neuromodulation technology designed for robustness, practical scalability, and broad deployment.”
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
tDCS- Limited Total Energy (tDCS-LTE) is an exclusive neuromodulation technology developed by Soterix Medical Inc. Invented at The City College of New York, tDCS-LTE is the only tDCS technology optimized for robust low-energy Transcranial Direct Current Stimulation. tDCS-LTE is under investigation in susceptible populations and is made possible through a proprietary adaptive stimulation limiting the voltage and power required for tDCS. It is the only non-invasive neuromodulation technology further optimized for robust deployment in a wide variety of environments including emergency medicine, home-use, etc.
Bipolar disorder: Bipolar disorder, also known as manic-depressive illness, is a brain disorder that causes unusual shifts in mood, energy, activity levels, and the ability to carry out day-to-day tasks. Symptoms of bipolar disorder are severe. They are different from the normal ups and downs that everyone goes through from time to time. Bipolar disorder symptoms can result in damaged relationships, poor job or school performance, and even suicide. If bipolar disorder can be treated, people with this illness can lead full and productive lives. People with bipolar disorder experience unusually intense emotional states that occur in distinct periods called "mood episodes." Each mood episode represents a drastic change from a person’s usual mood and behavior. An overly joyful or overexcited state is called a manic episode, and an extremely sad or hopeless state is called a depressive episode. Sometimes, a mood episode includes symptoms of both mania and depression. This is called a mixed state. People with bipolar disorder also may be explosive and irritable during a mood episode. Bipolar disorder can be present even when mood swings are less extreme. For example, some people with bipolar disorder experience hypomania, a less severe form of mania. During a hypomanic episode, you may feel very good, be highly productive, and function well. You may not feel that anything is wrong, but family and friends may recognize the mood swings as possible bipolar disorder. Without proper treatment, people with hypomania may develop severe mania or depression.