Back to resultsSpinal 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
About this trial
This is an interventional supportive care trial for Hypertension focused on measuring Hypertension, High Blood Pressure
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.
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
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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