Record Clinical Trial Enrollment Made Possible by IETF and Their Members

Patient recruitment is usually the biggest challenge in conducting clinical trials. Thanks to the International Essential Tremor Foundation and their members, Cala Health recently enrolled the largest therapeutic essential tremor study in record time.

By Kate Rosenbluth,
Founder/CEO of Cala Health, Inc.

About five years ago, my co-founders and I spun Cala Health out from Stanford University to develop a wearable therapy for essential tremor. We spent several months observing and interviewing patients, neurologists and neurosurgeons, and were captivated by the unmet need to give people back their hand control without undergoing brain surgery. The International Essential Tremor Foundation and its members gave generous time to helping us understand the condition and how we could help. We formed a company and began product development of a peripheral stimulation device worn on the wrist to interrupt the tremulous signal driving the tremor in the brain.

Photo of Cala CEO Kate Rosenbluth

Our careful research and development process brought us to the final stage, clinical trials. Clinical trials produce the most reliable data available for health care decision making. They follow strict scientific standards to protect patients and produce dependable study results. Oftentimes, the single greatest challenge in conducting a successful clinical trial is recruiting participants. Typically, most participants are recruited by physicians serving as Principal Investigators for the study, or by engaging advertising agencies to inform potential participants that a clinical trial is available. This can take months, if not years, and require significant investment in advertising.

Fortunately, Cala Health has partnered with the International Essential Tremor Foundation, who announced this research opportunity to their members nationwide. We immediately received interest from qualified participants who have been struggling with essential tremor for years and connected them with the leading neurologists in movement disorders who were participating in our trial. We have been so pleased with the response. Most recently, this generated and enrolled hundreds of patients into our PROSPECT study in record time. During the study, patients wore the therapy on their wrist like a smart watch and patterned electrical stimulation was delivered to the nerves through the skin twice per day over a three-month period. This fast enrollment enables a key milestone to share the results later this year and make this FDA-cleared therapy commercially available. 

People who take part in clinical trials are vital to the process of improving medical care. IETF is an essential partner to Cala Health informing the ET community of the clinical research opportunities to advance medical knowledge and patient care.

About Cala Health, Inc.

Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation. The first indication for Cala Health’s wearable therapy is essential tremor, a disease experienced by more than seven million people and characterized by severe hand tremors. Visit www.CalaTrio.com to learn more.  New therapies are under development in neurology, cardiology and psychiatry. The company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.

Being ‘Mindful’ May Help in Managing Essential Tremor

By Dr. Michael Braitsch, PT, DPT
Tribe Wellness, LLC

Photo of Michael Braitsch, Tribe WellnessIf you’re like me, you’ve heard over and over again the value of mindfulness. It’s become quite a popular buzzword in a variety of manners of marketing. As we enter the next frontier of neuroscience and brain health, it seems like you can’t go anywhere without hearing about mindfulness. But what does mindfulness really mean and how can it be useful in daily life or in managing life with a tremor?

As a physical therapist, I have seen time and again the role of increased stress ramping up the severity of a patient’s symptoms (whether it be chronic pain in someone’s lower back, the amplitude or frequency of a tremor, the incidence of freezing gait in someone with Parkinson’s disease – the  list goes on).

I’ve met many people though with an essential tremor who usually say something like, “If I really focus on it, I can kind of calm my tremor down.” This is mindfulness!

The even better news is that practicing mindfulness can have far reaching benefits to improve quality of life with or without a tremor. It makes good sense. When we are calmer, we learn better, we perform better, we are less distracted, and we can even tap into a level of subconscious skill to make life easier.

While this all sounds great, I’m also here to warn you that it takes some effort and consistency; however, we all know that most worthwhile things in life take some effort. The intention of this blog post is to clarify what mindfulness practice is and how it could be helpful.

What is Mindfulness?
Many people consider the practice of mindfulness as simply, being aware of the present moment and the task-at-hand. Merriam-Webster’s dictionary defines mindfulness as:

“1 : the quality or state of being mindful

2 : the practice of maintaining a nonjudgmental state of heightened or complete awareness of one’s thoughts, emotions, or experiences on a moment-to-moment basis “

So “mindfulness” is really a practice. It’s NOT a destination. It has a lot of similarities with meditation or directed thinking which is common in all religious beliefs, to quiet the mind you don’t have to run off to the mountains or join a monastery. Rather, mindfulness provides a method of intentionally directing one’s focus to the task-at-hand, while avoiding judgment (both good and bad).

Let’s break each of these down further.

Focus on the Present
An increased focus on the present moment is a heightened commitment to directing one’s attention to the task-at-hand. Even though the mind may wander, coming back to the present is the key for mindfulness. We are all human beings and have a natural tendency to consciously or unconsciously drift into other thoughts, but coming back to “right now” is the goal of this practice. Oddly enough, in a world where multi-tasking is everywhere, mindfulness practices teach us that we are more effective and more efficient when we slow down and focus on what we are doing.

Be Non-Judgmental
Each day we make thousands of decisions. For the sake of survival of the species, we have an evolutionary drive to constantly judge things as good or bad, helpful or harmful, useful or a waste of time. Using our “fight or flight” response has served us tremendously for thousands of years. This is often the hardest part of mindfulness. Reinforcement of use of the “fight or flight” hardwires us to rush ahead to the next moment. However, when we lose sight of the present and constantly let the mind race, neuroscience tells us that we strengthen our brains’ stress responses to everyday tasks. On an extreme level, a heightened stress-response can have far-reaching negative effects. While it’s helped humanity to survive, we’ve become hardwired to get bogged down by incessant mental chatter. Mindfulness shows us that we can remain focused on the task at hand without judgment, and on a very practical level, rewiring our brains from training a ”stress-response,” to instead, training a “relaxation response.”

As we strive to increase our focus and to quiet the mind, we can find an abundance of benefits from improved awareness. We can even gain insight into why we feel a certain way or perhaps a deeper level of relaxation. This training has a powerful effect on our autonomic nervous system. By choosing presence and mindfulness, a hyperactive brain or a hyperactive nervous system can be slowed down, leading to a wealth of benefits including improved cardiovascular health, improved cognition, and more!

But What About My Tremor?
Managing stress is great for everyone. For someone with a tremor, it can be even more helpful. Most people I’ve met who are dealing with essential tremor say something like, “my tremor gets worse when I’m stressed out.” Stress and depression can even create a negative cycle that increases the tremor currently, and because of embarrassment about worsening of the tremor, causes more stress and depression. While there have not yet been studies on practicing mindfulness as a means of managing essential tremor, there have been many anecdotal reports of it helping. It stands to reason that even if mindfulness did nothing for the tremor itself, the already established far-reaching benefits make it worth the effort until a study can show what so many people have already reported. Why not give yourself a chance to reduce stress and feel good, right?

Can I Practice Mindfulness While Exercising?
Now for my favorite topic. . .there are forms of exercise that harness and foster a mindful approach while also striving to calm the mind and strengthen the body. As a physical therapist, my life’s mission is to help people move better and feel better. The research on the role of exercise in managing stress is abundant to say the least. As a long-time martial artist, I’ve seen first-hand the changes that can occur with dedicated practice of martial arts and the increased sense of well-being that students develop. Tai Chi is easily the most common form of martial art with emphasis on mindful practice because it is low-impact, easy to modify, and because it focuses on breath with movement. Alternatively, yoga has provided an avenue for mindful training for centuries and pilates also employs a mindful approach to movement, capturing the benefits of mindfulness and exercise.

What Else Can I Look at to Learn More?
Mindfulness resources are everywhere! There is no shortage of resources when it comes to mindfulness. The best practice though, like the best exercise, is the one that you can do consistently.

Here are a few to start with: