Spinal Cord Stimulation to Treat Hypertension

University of Minnesota (UMN)

Status: Completed

Conditions: Hypertension

Treatments: Device: Precision Spectra System; Behavioral: Exercise Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02828436

1604M86961

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Spinal Cord Stimulation

Experimental group

Description:

Boston Scientific Precision Spectra System

Treatment:

Device: Precision Spectra System

Exercise Intervention

Other group

Description:

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

Treatment:

Behavioral: Exercise Intervention