Spinal Cord Stimulation for High Blood Pressure
(HTN-SCS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
High blood pressure, also called hypertension, raises the risk of heart disease, stroke, and kidney disease. Medications work well for many people, but some people still have blood pressure that stays too high, or they have side effects from their medications. Researchers are looking for treatments that do not involve taking more medication.
Nerves help control blood pressure by changing how blood vessels tighten and how hard the heart pumps. Because of this, treatments that act on nerves may be able to lower blood pressure.
Spinal cord stimulation is a treatment already used to manage long-term pain. It uses a small device, placed under the skin during a standard operation, that sends mild electrical signals to the spine. Laboratory studies suggest that stimulating the lower part of the mid-back may also lower blood pressure, but this has not been carefully studied in people who already use these devices.
This study will look at whether changing the settings on a spinal cord stimulator affects blood pressure. About 11 adults who have high blood pressure and who already have a spinal cord stimulator for long-term pain. No new device will be placed, and no surgery or other invasive procedure will be done for this study.
Participants attend a series of study visits. At each visit, trained staff record blood pressure and heart rate while the stimulator is turned on, turned off, and set to other settings that the person's care team has approved and that the person finds comfortable. There are rest breaks between each setting. Over successive visits, the study team works to identify the settings that best lower blood pressure. Participants can stop at any time, and their usual settings are restored at the end of each visit.
The study will also look at whether this kind of testing is practical and comfortable for participants. The results will help researchers decide whether larger studies of spinal cord stimulation for blood pressure control are worth doing.
Who Is on the Research Team?
Aaron Phillips, PhD
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for adults with high blood pressure who already have a spinal cord stimulator implanted to manage long-term pain. No new devices or surgeries are involved, and participants must be able to attend several study visits.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Lower Thoracic Spinal Cord Stimulation
Trial Overview
Researchers are testing if adjusting the settings on an existing lower thoracic spinal cord stimulator can help lower blood pressure in people with hypertension. The study involves monitoring blood pressure at different device settings during clinic visits.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adults with an existing implanted lower thoracic spinal cord stimulator for chronic pain undergo non-invasive cardiovascular monitoring during a series of stimulation conditions delivered through their own device. Conditions may include stimulation off, the participant's usual clinical program, and predefined alternative settings within clinically approved device parameters and participant tolerance, with rest periods between conditions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
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