Spinal Cord Stimulation for Blood Pressure Control in Hypertension
ConditionHypertension (HTN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older
Existing implanted spinal cord stimulator with leads positioned in the lower thoracic region as part of routine clinical treatment for chronic pain
Device functioning appropriately and participant cleared for routine programming adjustments by the treating clinical team
Able to understand study procedures and provide informed consent
Disqualifiers
Inability or unwillingness to provide informed consent
Pregnancy, if deemed clinically relevant by investigators or treating physicians
Unstable cardiovascular disease (e.g., uncontrolled arrhythmia, recent myocardial infarction, severe symptomatic hypotension, hypertensive emergency, or other conditions where stimulation testing may increase risk)
Acute illness or infection at the time of study visit
Trial design
Design model
Single group
Treatments tested in this trial
Lower Thoracic Spinal Cord Stimulation
DeviceTemporary 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.
Treatment groups
11 Participants
are divided into 1 treatment groupGroup A: Spinal Cord Stimulation TestingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Diastolic Blood Pressure Across Spinal Cord Stimulation Conditions
Change in diastolic blood pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
Time frame
Through study completion, an average of 1 year2
Change in Systolic Blood Pressure Across Spinal Cord Stimulation Conditions
Change in systolic blood pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
Time frame
Through study completion, an average of 1 year3
Change in Mean Arterial Pressure Across Spinal Cord Stimulation Conditions
Change in mean arterial pressure measured by validated non-invasive automated monitoring, compared across spinal cord stimulation conditions (stimulation off, the participant's usual clinical program, and predefined alternative settings).
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
Number of Participants Reporting Stimulation-Related Symptoms
Number of participants reporting one or more of the following during any stimulation condition: dizziness, discomfort, paresthesia, or increased pain. Symptoms are elicited by direct questioning by study personnel at each stimulation condition and recorded as present or absent.
Time frame
Up to 12 months2
Time to Onset of Blood Pressure Change Following Change in Stimulation Condition
Time from a change in stimulation condition to the first measurable change in blood pressure, assessed by continuous non-invasive blood pressure monitoring.
Time frame
Up to 12 months3
Change in Heart Rate Across Spinal Cord Stimulation Conditions
Heart rate recorded during each spinal cord stimulation testing condition.
Time frame
up to 12 months4
Number of Participants Completing the Full Testing Protocol
Number of participants who complete all planned stimulation conditions across all scheduled study visits.
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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