Spinal Cord Stimulation to Treat Hypertension

August 25, 2020 updated by: University of Minnesota

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Manda Keller-Ross, PhD, DPT, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

July 6, 2016

First Posted (Estimate)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1604M86961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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