Spinal Cord Stimulation for Blood Pressure Control in Hypertension

NCT07842315 | Not Yet Recruiting

• 1 other identifier: REB26-0222
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension (HTN)

Keywords

spinal cord stimulation; neuromodulation; blood pressure; autonomic nervous system; epidural electrical stimulation

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Number of Participants Reporting Stimulation-Related Symptoms

  Up to 12 months

• Time to Onset of Blood Pressure Change Following Change in Stimulation Condition

  Up to 12 months

• Change in Heart Rate Across Spinal Cord Stimulation Conditions

  up to 12 months

• Number of Participants Completing the Full Testing Protocol

  Up to 12 months

• Duration of Blood Pressure Change Following Change in Stimulation Condition

  Up to 12 months

Study Arms (1)

Spinal Cord Stimulation Testing

EXPERIMENTAL

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

Interventions

Lower Thoracic Spinal Cord Stimulation DEVICE

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.

Spinal Cord Stimulation Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to attend the study visit and tolerate temporary monitoring and stimulation testing
• Documented hypertension or current use of antihypertensive medication

You may not qualify if:

• 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
• Implanted stimulator malfunction or clinical concerns regarding device use
• Severe cognitive impairment or communication barriers preventing safe participation
• Any other medical or clinical reason identified by the investigator or treating clinician that would make participation unsafe

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Foothills Medical Center

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (5)

• Darrow D, Balser D, Netoff TI, Krassioukov A, Phillips A, Parr A, Samadani U. Epidural Spinal Cord Stimulation Facilitates Immediate Restoration of Dormant Motor and Autonomic Supraspinal Pathways after Chronic Neurologically Complete Spinal Cord Injury. J Neurotrauma. 2019 Aug 1;36(15):2325-2336. doi: 10.1089/neu.2018.6006. Epub 2019 Mar 6.

  PMID: 30667299 RESULT

• West CR, Phillips AA, Squair JW, Williams AM, Walter M, Lam T, Krassioukov AV. Association of Epidural Stimulation With Cardiovascular Function in an Individual With Spinal Cord Injury. JAMA Neurol. 2018 May 1;75(5):630-632. doi: 10.1001/jamaneurol.2017.5055.

  PMID: 29459943 RESULT

• Harkema SJ, Wang S, Angeli CA, Chen Y, Boakye M, Ugiliweneza B, Hirsch GA. Normalization of Blood Pressure With Spinal Cord Epidural Stimulation After Severe Spinal Cord Injury. Front Hum Neurosci. 2018 Mar 8;12:83. doi: 10.3389/fnhum.2018.00083. eCollection 2018.

  PMID: 29568266 RESULT

• Phillips AA, Gandhi AP, Hankov N, Hernandez-Charpak SD, Rimok J, Incognito AV, Nijland AEJ, D'Ercole M, Watrin A, Berney M, Damianaki A, Dumont G, Macellari N, De Herde L, Intering N, Smith D, Miller R, Smith MN, Lee J, Baaklini E, Ledoux JB, Ordonnez JG, Newton T, Meliado EF, Duguet L, Jacquet C, Bole-Feysot L, Rieger M, Gelenitis K, Dumeny Y, Caban M, Ganty D, Paoles E, Baumgartner T; Clinical Study Team; Onward Team; Harte C, Sasportes CD, Romo P, Vouga T, Fasola J, Ravier J, Gautier M, Merlos F, Buschman R, Milekovic T, Rowald A, Mandija S, van den Berg CAT, Kuster N, Neufeld E, Pralong E, Hirt L, Carda S, Becce F, Aleton E, Rogan K, Schoettker P, Wuerzner G, Langerak N, Keijsers NLW, Kwon BK, Guest JD, Ross E, Murphy J, Kurt E, Casha S, Girgis F, van Nes I, Larkin-Kaiser KA, Demesmaeker R, Asboth L, Squair JW, Bloch J, Courtine G. An implantable system to restore hemodynamic stability after spinal cord injury. Nat Med. 2025 Sep;31(9):2946-2957. doi: 10.1038/s41591-025-03614-w. Epub 2025 Sep 17.

  PMID: 40962906 RESULT

• Croom JE, Foreman RD, Chandler MJ, Barron KW. Cutaneous vasodilation during dorsal column stimulation is mediated by dorsal roots and CGRP. Am J Physiol. 1997 Feb;272(2 Pt 2):H950-7. doi: 10.1152/ajpheart.1997.272.2.H950.

  PMID: 9124459 RESULT

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Aaron Phillips, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RESTORE Research Coordinator

CONTACT

403-220-5672; alex.wang2@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)