Spinal Cord Stimulation to Treat Hypertension



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 90
Updated:6/2/2018
Start Date:March 22, 2017
End Date:December 2018
Contact:Dan Chantigian
Email:chant047@umn.edu
Phone:612-624-6534

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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.

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.

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.
We found this trial at
2
sites
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-6534
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, Minnesota 55455
Principal Investigator: Manda L Keller-Ross, PhD, DPT
Phone: 612-624-6534
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