Spinal Cord Stimulation to Treat Hypertension

NCT ID: NCT02828436

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2019-09-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Spinal Cord Stimulation

Boston Scientific Precision Spectra System

Group Type: EXPERIMENTAL

Precision Spectra System

Intervention Type: DEVICE

Spinal Cord Stimulation

Exercise Intervention

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

Group Type: OTHER

Exercise Intervention

Intervention Type: BEHAVIORAL

Standard Exercise

Interventions

Precision Spectra System

Spinal Cord Stimulation

Intervention Type: DEVICE

Exercise Intervention

Standard Exercise

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manda Keller-Ross, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1604M86961

Identifier Type: -

Identifier Source: org_study_id