Spinal Cord Stimulation to Treat Hypertension

Study Overview
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Brief Summary
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To investigate the exercise blood pressure response during a lower-extremity dynamic exercise in postmenopausal women with hypertension and to determine if lumbar epidural spinal cord stimulation reduces blood pressure during exercise in postmenopausal women and men with hypertension.

Detailed Description
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This is a single center study conducted at the University of Minnesota, enrolling up to forty subjects (30 men and 30 post-menopausal women). Subjects will be a assigned to one of the two study arms, (Dynamic Exercise or Spinal Cord Stimulation) and then crossover to the other arm after the initial assignment is complete. However is the screening MRI determines the subject is not a candidate for spinal cord stimulation, then they will be assigned to the Dynamic Exercise arm only.

Official Title
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A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Device: Precision Spectra System
* Behavioral: Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and post-menopausal women between the ages of 40-90 years old Hypertension (defined as BP ≥ 140/90), diagnosed by a physician Ability of the patient to provide consent Exclusion Criteria: History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision) Currently taking specific anti-hypertensive medications that may affect the exercise pressor response or influence the effect of spinal cord stimulation. Please contact study staff for information regarding your eligibility. History of spinal fusion or laminectomy at L3 or above Current prescription opioid usage Contraindication to MRI At physician discretion which will be documented on the case report form.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation<br>Boston Scientific Precision Spectra System | Device: Precision Spectra System<br>* Spinal Cord Stimulation<br>|
| Other: Exercise Intervention<br>If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm | Behavioral: Exercise Intervention<br>* Standard Exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Exercise Pressor Reflex From Baseline | Change in blood pressure during exercise. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, High Blood Pressure