SET medical device

Mission – To make people pain free

Problem

Chronic pain is one of the most under-recognized and undertreated medical problems of the 21st century. Persistent pain seriously reduces the quality of life for millions of sufferers and tears at the economic and social fabric of our culture. Chronic pain is defined as an unpleasant sensory and emotional experience lasting longer than three months and is the leading cause of disability in the workplace. Chronic pain includes fibromyalgia, migraine/cluster headache, back pain, TMD, osteo- and rheumatoid arthritis, cancer pain, inflammatory muscle pain, and neuropathic pain. On average, according to the WHO, people live with their chronic pain for 7 years.

Blackburn-Monrot (2001) and other studies show that persistent stress is a leading cause of many forms of chronic pain. However, patients have different physiologies, so a solution for one patient may or may not work for the next. As one example of this heterogeneity, a subgroup of patients increase their muscle tension under stress, whereas another increase their blood pressure. Determining the optimum treatment for each patient requires large amounts of data, which must be collected from thousands of patients. Only with detailed patient-specific data can the proper chronic pain treatment be administered.

Solution

SET Medical Device

The SET device stimulates the patient through the finger and saves and stores patient physical data. The device also calculates baroreceptor sensitivity (BRS).

Chronic pain patients display a reduced BRS as compared to healthy controls. Using BRS as a biomarker, therapists can monitor the effectiveness of the SET protocol and treatment. Freedom from pain is associated with an increase in patient BRS.

The optimum stimulation and therapy parameters can then be downloaded to a custom treatment device. This intelligent, learning, database supported pain treatment model will revolutionize chronic pain treatment by 1) individualizing each patient’s treatment protocol and 2) adjusting the treatment based upon patient progress. The system will learn and get better as more and more therapy and patient experience is gathered.

The SET behavioral therapy protocol was adapted by Dr. Thieme, from leading pain specialists Herta Flor and Niels Birbaumer, based upon work by Dennis Turk at the University of Washington, USA. The protocol is documented in a Moodle (open source) E-learning program for both patients and therapists. Our approach to chronic pain was developed by a team of international pain specialists including Dr. Kati Thieme (CTO), who won the German pain prize in 2012, Dr. Richard Gracely, University of North Carolina (UNC), and Dr. Bill Maixner, Duke University. The key technology for the novel medical device is patented by UNC, which has granted Kleinklein exclusive rights in Europe to develop, integrate, and commercialize the technology throughout Europe. The concept and approach were presented at world leading pain events including the 2014 International Association for the Study of Pain (IASP) and the 2015 German Pain Conference. Both the SET protocol and the opportunity to have data drive an interactive solution which considers actual patient heterogeneity made a big impact among the attending professionals. SET will both make the largest subgroup of patients pain-free for longer than 6 months, and supply jobs for therapists.

Mechanism

SET uses novel individualized painful and pain-free electrical stimulations to the finger timed to coincide with the systolic and diastolic points in the cardiac cycle. The stimulation raises BRS, which is diminished in chronic pain patients. SET combines this stimulation with operant behavioral therapy to put in place healthy behaviors. During a 2-hour session, the SET device is applied for two 8-minute periods. The therapy practices healthy behaviors. The operant approach is to learn by doing rather than directly attempting a cognitive change (CBT). The standard treatment requires 10 double sessions over 5 weeks (20 hours) with a behavioral therapist and for several sessions their partner. A therapist and patient E-learning program defines the protocol, session by session, and tracks patient exercises.

The set device uses the ANS to disrupt brain patterns and renew itself through 8-minute cardiac gated electrical stimuli. When the pattern is upset, the brain is more plastic and receptive to learning. Operant conditioning and behavioral training correct the behavior, cognition, and reward structure that maintains pain. SET has a long term effect (6-12 months) and can be refreshed if needed. It works for the over ½ of people with hypertensive stress response who are willing to change their behaviors. Exclusion criteria are ongoing opioid, antidepressant, and beta-blocker use as well as personality disorders.