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Spinal Cord Stimulation to Treat Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Precision Spectra System
Exercise Intervention
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Hypertension, High Blood Pressure

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Minnesota Medical Center
  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Spinal Cord Stimulation

Exercise Intervention

Arm Description

Boston Scientific Precision Spectra System

If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm

Outcomes

Primary Outcome Measures

Change in Exercise Pressor Reflex From Baseline
Change in blood pressure during exercise.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2016
Last Updated
August 25, 2020
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02828436
Brief Title
Spinal Cord Stimulation to Treat Hypertension
Official Title
A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, High Blood Pressure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Boston Scientific Precision Spectra System
Arm Title
Exercise Intervention
Arm Type
Other
Arm Description
If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm
Intervention Type
Device
Intervention Name(s)
Precision Spectra System
Intervention Description
Spinal Cord Stimulation
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Standard Exercise
Primary Outcome Measure Information:
Title
Change in Exercise Pressor Reflex From Baseline
Description
Change in blood pressure during exercise.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manda Keller-Ross, PhD, DPT
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Spinal Cord Stimulation to Treat Hypertension

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