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Completed

NCT Number: NCT02828436

Spinal Cord Stimulation to Treat Hypertension

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.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precision Spectra System

Device

Spinal Cord Stimulation

Exercise Intervention

Behavioral

Standard Exercise

Primary outcomes

  1. Change in Exercise Pressor Reflex From Baseline

    Time frame: 2 years

    Change in blood pressure during exercise.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 11, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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