Spinal Cord Stimulation to Treat Hypertension
A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension
1 other identifier
interventional
9
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hypertension
Started Mar 2017
Typical duration for not_applicable hypertension
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
July 11, 2016
CompletedStudy Start
First participant enrolled
March 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedResults Posted
Study results publicly available
September 16, 2020
CompletedSeptember 16, 2020
August 1, 2020
2.4 years
June 15, 2016
August 25, 2020
August 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Exercise Pressor Reflex From Baseline
Change in blood pressure during exercise.
2 years
Study Arms (2)
Spinal Cord Stimulation
EXPERIMENTALBoston Scientific Precision Spectra System
Exercise Intervention
OTHERIf subject cannot tolerate Spinal Cord stimulation they will be assigned this arm
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manda Keller-Ross
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Manda Keller-Ross, PhD, DPT
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
July 11, 2016
Study Start
March 22, 2017
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
September 16, 2020
Results First Posted
September 16, 2020
Record last verified: 2020-08