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NOT YET RECRUITING
NCT07842315
NA

Spinal Cord Stimulation for Blood Pressure Control in Hypertension

Sponsor: University of Calgary

View on ClinicalTrials.gov

Summary

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.

Official title: Characterizing the Effect of Epidural Electrical Stimulation on Blood Pressure in Hypertensive Individuals With Implanted Spinal Cord Stimulators

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2026-11-01

Completion Date

2030-11-01

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DEVICE

Lower Thoracic Spinal Cord Stimulation

Temporary activation, deactivation, or adjustment of stimulation settings on the participant's existing clinically implanted lower thoracic spinal cord stimulator, performed by personnel qualified in spinal cord stimulator programming. All adjustments remain within clinically approved device parameters and within participant tolerance. No new device is implanted and no invasive research procedure is performed. Non-invasive blood pressure and heart rate are monitored continuously or repeatedly across stimulation conditions. Predefined stopping criteria apply, and the participant's usual clinical stimulator settings are restored at the conclusion of testing.

Locations (1)

Foothills Medical Center

Calgary, Alberta, Canada