Spinal Cord Stimulation to Treat Hypertension

University of Minnesota9 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Precision Spectra SystemDEVICE

Spinal Cord Stimulation

Exercise InterventionBEHAVIORAL

Standard Exercise

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and post-menopausal women between the ages of 40-90 years old 2. Hypertension (defined as BP ≥ 140/90), diagnosed by a physician 3. Ability of the patient to provide consent Exclusion Criteria: 1. History of cardiopulmonary disorders other than hypertension, as determined on the medical evaluation questionnaire. 2. History of dangerous arrhythmias (arrhythmias requiring treatment or requiring physician supervision) 3. 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. 4. History of spinal fusion or laminectomy at L3 or above 5. Current prescription opioid usage 6. Contraindication to MRI 7. At physician discretion which will be documented on the case report form.

Locations (2)

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Change in Exercise Pressor Reflex From Baseline

Change in blood pressure during exercise.

Time frame: 2 years

Data from ClinicalTrials.gov

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