An interventional study of Lower Thoracic Spinal Cord Stimulation in Hypertension (HTN), sponsored by University of Calgary. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Calgary · Not applicable, Interventional, and Basic science
Among 12 studies in Hypertension by University of Calgary — 2 open to participants now, 2 under way, none of them phase 3. Hypertension · University of Calgary.
Among the 12 studies in Hypertension by University of Calgary, this one is the 11th largest by planned enrollment, is one of 2 that started in 2026, is one of 10 with no phase, and was the 12th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 11 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →2 of the 12 studies in Hypertension by University of Calgary are open now, in 1 country. Each count lists the studies.
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 2 started in 2026.
Median enrollment 106 across the 12 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
1 of the studies in Hypertension by University of Calgary that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07796048University of CalgaryRegular Sauna Use to Lower Blood Pressure in Primary Aldosteronism | 2027-09-30 |
Among the 12 studies in Hypertension by University of Calgary, from their registry updates:
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.
Hypertension is a major modifiable risk factor for cardiovascular disease, stroke, heart failure, and chronic kidney disease. Although effective antihypertensive medications are available, a proportion of individuals have inadequately controlled blood pressure, experience adverse medication effects, or require multiple agents to reach target. This has sustained interest in adjunctive, non-pharmacological approaches to blood pressure management.
The autonomic nervous system regulates blood pressure through modulation of vascular tone, cardiac output, and reflex control mechanisms, and elevated sympathetic activity is implicated in the pathogenesis and maintenance of hypertension. Device-based therapies including renal denervation and baroreflex activation therapy provide proof of concept that targeted neuromodulation can lower arterial pressure.
Spinal cord stimulation is an established clinical therapy for chronic pain. Individuals with implanted lower thoracic spinal cord stimulators represent a population in which the cardiovascular effects of spinal neuromodulation can be examined without exposing participants to a new implantation procedure. Preclinical work indicates that stimulation of lower thoracic spinal segments can acutely reduce arterial blood pressure through modulation of autonomic pathways; these effects have not been well characterized in humans with existing systems.
Study procedures: Participants attend a series of study visits conducted in a monitored clinical or research setting. Stimulation parameters are iteratively optimized across visits to identify settings that reduce blood pressure. Baseline assessment includes demographic information, relevant medical history, medication review (including antihypertensive and analgesic medications), and resting blood pressure and heart rate. Continuous or repeated non-invasive blood pressure monitoring is performed throughout the session; additional monitoring may include electrocardiography and pulse oximetry.
Stimulation testing is performed using the participant's own implanted system by personnel qualified in spinal cord stimulator programming. Adjustments remain within clinically approved device parameters and within participant tolerance. Rest periods are provided between conditions to allow return toward baseline.
Predefined stopping criteria apply: testing is discontinued if a participant reports discomfort, anxiety, worsening pain, dizziness, or symptomatic hypotension, or requests to stop for any reason. Usual clinical stimulator settings are restored at the conclusion of testing, and participants are observed until stable before discharge.
Because the design is within-subject, each participant serves as their own control across stimulation conditions, which improves efficiency in a small sample. The study is powered for estimation rather than hypothesis testing; emphasis is placed on effect sizes, variance estimates, and confidence intervals to inform protocol refinement and formal sample size calculation for future controlled trials.
Safety monitoring: Blood pressure, heart rate, and oxygen saturation are monitored continuously throughout all stimulation. Stimulation is stopped immediately for any of the following: a fall in systolic blood pressure greater than 40 mmHg from baseline, or an absolute systolic blood pressure below 85 mmHg; a rise in systolic blood pressure greater than 30 mmHg above baseline; new-onset bradycardia (heart rate below 45 bpm) or tachycardia (heart rate above 130 bpm); participant request, for any reason; or new unexpected neurological symptoms, including limb weakness or paralysis, new bladder urgency or incontinence, or spreading numbness or dysesthesia beyond the expected trunk sensory field. Trunk muscle contractions at the amplitudes used are anticipated and are not a stopping criterion. Testing is also discontinued if a participant reports discomfort, anxiety, worsening pain, or dizziness. Usual clinical stimulator settings are restored at the conclusion of testing, and participants are observed until stable before discharge.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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 year
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 year
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 year
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 months
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 months
Change in Heart Rate Across Spinal Cord Stimulation Conditions
Heart rate recorded during each spinal cord stimulation testing condition.
Time frame: up to 12 months
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 months
Duration of Blood Pressure Change Following Change in Stimulation Condition
Time from onset of blood pressure change to return toward pre-condition baseline following a change in stimulation condition, assessed by continuous non-invasive blood pressure monitoring.
Time frame: Up to 12 months
Peak Magnitude of Blood Pressure Change Following Change in Stimulation Condition
Maximum change in mean arterial pressure from pre-condition baseline following a change in stimulation condition, assessed by continuous non-invasive blood pressure monitoring.
Time frame: Up to 12 months
Plan to share: No — There is no plan to share individual participant data with other researchers. This study is not intended to create an open-access registry or public database, and identifiable data will not be transferred outside the research team except where required by law, institutional audit, or regulatory oversight. De-identified data may be retained for future secondary analyses related to spinal cord stimulation, autonomic regulation, or cardiovascular outcomes where consistent with participant consent and institutional policy. Any data linkage or sharing beyond the current approval would require additional ethics review and, where applicable, participant consent.
Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.
Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 36 months is above that.
Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.