Trial Outcomes & Findings for Spinal Cord Stimulation to Treat Hypertension (NCT NCT02828436)
NCT ID: NCT02828436
Last Updated: 2020-09-16
Results Overview
Change in blood pressure during exercise.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
2 years
Results posted on
2020-09-16
Participant Flow
Participant milestones
| Measure |
Spinal Cord Stimulation
Boston Scientific Precision Spectra System
Precision Spectra System: Spinal Cord Stimulation
|
Exercise Intervention
If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm
Exercise Intervention: Standard Exercise
|
|---|---|---|
|
Period 1
STARTED
|
0
|
9
|
|
Period 1
COMPLETED
|
0
|
5
|
|
Period 1
NOT COMPLETED
|
0
|
4
|
|
Period 2
STARTED
|
9
|
0
|
|
Period 2
COMPLETED
|
1
|
0
|
|
Period 2
NOT COMPLETED
|
8
|
0
|
Reasons for withdrawal
| Measure |
Spinal Cord Stimulation
Boston Scientific Precision Spectra System
Precision Spectra System: Spinal Cord Stimulation
|
Exercise Intervention
If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm
Exercise Intervention: Standard Exercise
|
|---|---|---|
|
Period 1
Did Not Meet Inclusion Criteria
|
0
|
3
|
|
Period 1
Lost to Follow-up
|
0
|
1
|
|
Period 2
Withdrawal by Subject
|
4
|
0
|
|
Period 2
Did Not Meet Inclusion Criteria
|
3
|
0
|
|
Period 2
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Spinal Cord Stimulation to Treat Hypertension
Baseline characteristics by cohort
| Measure |
All Participants
n=5 Participants
This is a cross-over study. All participants are pooled at baseline.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsChange in blood pressure during exercise.
Outcome measures
| Measure |
Spinal Cord Stimulation
n=1 Participants
Boston Scientific Precision Spectra System
Precision Spectra System: Spinal Cord Stimulation
|
Exercise Intervention
n=5 Participants
If subject cannot tolerate Spinal Cord stimulation they will be assigned this arm
Exercise Intervention: Standard Exercise
|
|---|---|---|
|
Change in Exercise Pressor Reflex From Baseline
|
8.67 mmHG
Standard Error NA
Only one participant included in this arm. Standard error is not applicable. Data reported were collected during dynamic exercise arm.
|
16.29 mmHG
Standard Error 1.82
|
Adverse Events
Spinal Cord Stimulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Exercise Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place