Magneto-rheology to Lower Blood Pressure

GOAL: Conduct pivotal clinical trials with Magnetic Blood Pressure Lowering (MBPL) Device, developed in this lab, to see how effective it can lower patients' high blood pressure. The pilot study has confirmed the safety and performance of the device. The pivotal tests will test a large population of subject with hypertension to determine the effectiveness of the MBPL device and check if there is any adverse effect. RECRUITMENT: For the pivotal clinical trials, subjects in second stage of hypertension will be selected: the systolic blood pressure in a range of 140-180 mmHg or diastolic blood pressure in a range 90-120 mmHg. For safety, subjects, who have a pacemaker or other metallic devices implanted, will not be selected. In addition, any adults unable to consent, cognitively impaired adults, and subjects who are not yet adults (infants, children, teenagers), pregnant women, and prisoners, will not be admitted. STUDY: The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10 cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. The subject's blood pressure will be measured first. Afterwards, the subject will place his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment will last about 15 minutes. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved. ANALYSES: During the magnetic treatment, the MBPL device applies a strong magnetic field along the blood flow direction in subjects' right arm. Under the magnetic field, the deoxygenated red blood cells are polarized and form short chains along the blood flow direction. The blood circulation brings these chains to the whole body. Based on the lab results, the blood viscosity along the flow direction will be reduced by 10-20% or more; the turbulence in blood circulation will be suppressed by the treatment if the subject has turbulence in the blood circulation. As a result, the blood flow will become laminar and the blood pressure will be lowered. The above effects will last for about 24 hours after the treatment and slowly decay. However, re-treatment will bring the effects back. In long term, the magnetic treatment could prevent development of atherosclerotic plaques in blood vessels. The effectiveness of the magnetic treatment will be determined by * evaluating the reduction of the systolic blood pressure and diastolic blood pressure immediately after the magnetic treatment; * comparing the blood pressure 24 hours after the magnetic treatment with the initial blood pressure before the magnetic treatment and evaluating any reduction.