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The William Harvey Research Institute - Faculty of Medicine and Dentistry

Could a short low-intensity stimulation of the ear lower blood pressure? World’s first trial begins recruitment

Afferent Medical Solutions Ltd in collaboration with researchers from Queen Mary University of London are running a clinical trial to determine if its AffeX device can reduce blood pressure by delivering a low voltage current to the specific region of the ear on a periodic basis.

AffeX Device

AffeX Device.

High blood pressure, also known as hypertension, is a condition where the pressure of blood in your arteries in consistently high. When your blood pressure is high, your heart has to work harder to circulate blood around your body. Therefore, high blood pressure increases the risk of several serious conditions, including heart attacks, strokes, heart failure, kidney failure and dementia and remains a major cause of premature death worldwide. Reducing blood pressure, even by a small degree, can have a significant impact on the risk of these diseases.

Most people can lower their blood pressure by changing their lifestyle or taking medication. However, this isn’t always possible and we now know that more than half of all patients with hypertension (1.4 billion worldwide) fail to control their blood pressure: the lack of an effective therapy for this group is a major health challenge and an urgent unmet clinical need.

It has been demonstrated clinically that reducing the output from adjusting the autonomic nervous system can be successful in reducing blood pressure for some people. Researchers at Queen Mary University of London are running a clinical trial to test whether a new medical device can lower a person’s blood pressure by applying a very small electrical current to the specific regions of the ear. 

AffeX, developed by Afferent Medical Solutions Ltd, is a device that delivers such stimulation for the purpose of ‘calming’ nerves in the autonomic nervous system. Observational proof-of-concept studies with the AffeX device showed promising results – prolonged reduction of blood pressure in patients for many weeks or months after.  When the patient’s blood starts to rise, treatment can be repeated. Treatment with AffeX is divided into two phases: an initial phase of daily stimulation for half-an hour for two weeks, and then weekly stimulation.

Effective treatment for uncontrolled hypertension is a global unmet clinical need. Unlike other non-pharmacological solutions (renal nerve denervation and baroreflex stimulation) which use expensive invasive devices and hospital-based procedures, AffeX’s key attributes of being very safe, non-invasive, and together with being handheld and low-cost, enables treatment to be self-administered by patients at home.

The SCRATCH-HTN study is a Phase 2 blinded randomised clinical trial aimed at evaluating the clinical efficacy and safety of AffeX to reduce blood pressure (hypertension) in patients with uncontrolled hypertension.

Queen Mary researchers are now recruiting participants for a clinical trial called SCRATCH-HTN which will determine how effective this technology is at lowering blood pressure in a larger number of patients. If the trial is successful, it could lead to a cost-effective, non-invasive treatment option for hypertension. The trial is funded by the National Institute for Health and Care Research (NIHR), the research partner of the NHS, public health and social care.  Patients wishing to take part in this study should visit the SCRATCH-HTN trial website for further details about the study and the clinical team contact information.

Chief Investigator, Dr Ajay Gupta, Senior Clinical Lecturer at Queen Mary and Honorary Consultant in Clinical Pharmacology and Cardiovascular Medicine, said:

“The SCRATCH-HTN study is an important study.  Whilst antihypertensive medication is effective and safe for the vast majority of patients, there is a large proportion who are resistant to the medications or have issues with intolerance, adverse effects or poor adherence, particularly for those who are prescribed 3-5 different drugs. These patients have no other regulatory-approved alternatives and often remain with uncontrolled blood pressure. This puts this group of patients at a high risk of heart attacks, strokes, and organ damage. Therefore, it is vital that we find some alternative additional strategies for these patients. If the Afferent’s treatment is a success, it could be a potential solution to reduce these patients’ risk of having a stroke, heart attack, heart failure, renal failure, and possibly dementia.”

Chairman of Afferent Medical Solutions Ltd, Professor Michael Spyer said:

“This innovation is a result of many years of research into the biological mechanisms underlying control of the heart by the nervous system. This device has the potential to help many patients with high blood pressure. As the former Chairman of NHS London, I am very aware of the burden hypertension places of the NHS resources as 1 in 4 adults in the UK having high blood pressure.  This new technology could enable the NHS and other healthcare providers across the world not only to meet the needs of these patients but also to reduce the cost of providing treatment.”




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