N/A
N=9
Spinal Cord Stimulation to Treat Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02828436 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Change in Exercise Pressor Reflex From Baseline — 8.67; 16.29 mmHG
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Precision Spectra System (Device); Exercise Intervention (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exercise Pressor Reflex From Baseline |
8.67; 16.29 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02828436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.