HypertensionNCT02828436
Spinal Cord Stimulation to Treat Hypertension
A study testing Precision Spectra System and Exercise Intervention in people with Hypertension, run by University of Minnesota at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Precision Spectra System and Exercise Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2017to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
Read the 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
- Being tested
- Precision Spectra System, Exercise Intervention
- Keywords
- Hypertension, High Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision Spectra SystemDevice
Spinal Cord Stimulation
Exercise InterventionBehavioural
Standard Exercise
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Boston Scientific Precision Spectra System Receives: Device: Precision Spectra System |
| Exercise Intervention | Other | If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm Receives: Behavioral: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exercise Pressor Reflex From Baseline
Change in blood pressure during exercise.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start22 Mar 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manda Keller-Ross, PhD, DPT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828436
- Sponsor's protocol ID
- 1604M86961
- Status last verified
- Aug 2020
- First submitted
- 15 Jun 2016
- Last updated
- 16 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Spinal Cord Stimulation To Inhibit Afferent Feedback During Exercise in Hypertension
- ClinicalTrials.gov ID
- NCT02828436
- Acronym / sponsor ID
- 1604M86961
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Posted 16 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Device: Precision Spectra SystemBoston Scientific Precision Spectra System |
| Exercise Intervention | Other | Behavioral: Exercise InterventionIf subject cannot tolerate Spinal Cord stimulation they will be assigned this arm |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision Spectra SystemSpinal Cord Stimulation | Device | Spinal Cord Stimulation |
| Exercise InterventionStandard Exercise | Behavioural | Exercise Intervention |
Primary outcome
Change in Exercise Pressor Reflex From Baseline
Time frame: 2 years
Change in blood pressure during exercise.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manda Keller-Ross, PhD, DPT principal investigator
University of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision Spectra System and Exercise Intervention in people with Hypertension, run by University of Minnesota at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Exercise Pressor Reflex From Baseline (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.