Spinal Cord Stimulation to Treat Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Precision Spectra System; Behavioral: Exercise Intervention

• Registration Number: NCT02828436
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-11
• Study Start: 2017-03-22
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2020-08
• Results First Submitted: 2020-08-25
• Results First Submitted QC: 2020-08-25
• Last Update Submitted: 2020-08-25
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Spinal Cord Stimulation	Precision Spectra System	Boston Scientific Precision Spectra System
Exercise Intervention	Exercise Intervention	If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm

Primary Outcome Measures

Name	Time	Method
Change in Exercise Pressor Reflex From Baseline	2 years	Change in blood pressure during exercise.

Trial Locations

Locations (2)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States