Trial Outcomes & Findings for Transcutaneous Stimulation in Spinal Cord Injury (NCT NCT05180227)
NCT ID: NCT05180227
Last Updated: 2025-09-22
Results Overview
Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
From enrollment to the end of the last study visit, approximately 30 days.
Results posted on
2025-09-22
Participant Flow
10 potential participants were screened and enrolled between June 2022 and December 2023.
Participant milestones
| Measure |
People With Spinal Cord Injury
People with chronic spinal cord injury undergoing spinal cord stimulation to increase and stabilize seated systolic blood pressure.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
People With Spinal Cord Injury
People with chronic spinal cord injury undergoing spinal cord stimulation to increase and stabilize seated systolic blood pressure.
|
|---|---|
|
Overall Study
Hypertension at screening
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Transcutaneous Stimulation in Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Participants Receiving Spinal Cord Stimulation to Increase and Stabilize Systolic Blood Pressure
n=10 Participants
Demographic, ethnic and spinal cord injury-specific characteristics of the participants enrolled in the trial
|
|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
|
Neurological level of spinal cord injury
Cervical
|
7 Participants
n=5 Participants
|
|
Neurological level of spinal cord injury
Thoracic
|
3 Participants
n=5 Participants
|
|
AIS classification of injury
AIS A
|
4 Participants
n=5 Participants
|
|
AIS classification of injury
AIS B
|
4 Participants
n=5 Participants
|
|
AIS classification of injury
AIS C
|
2 Participants
n=5 Participants
|
|
Time since injury
|
15.9 years
STANDARD_DEVIATION 16.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the end of the last study visit, approximately 30 days.Seated systolic blood pressure response to spinal cord stimulation at T7/T8, T9/10, T11/12, L1/L2) to determine the best cathode electrode placement on the spine that increases systolic blood pressure between 110-130 mmHg.
Outcome measures
| Measure |
No Stimulation
n=8 Participants
Seated blood pressure will be assessed without TSCS.
|
T7/8
n=8 Participants
Seated blood pressure assessed with TSCS at T7/8.
|
T9/10
n=6 Participants
Seated blood pressure assessed with TSCS at T9/10.
|
T11/12
n=6 Participants
Seated blood pressure assessed with TSCS at T11/12.
|
L1/2
n=6 Participants
Seated blood pressure assessed with TSCS at L1/2.
|
|---|---|---|---|---|---|
|
Seated Systolic Blood Pressure
|
86 mmHg
Standard Deviation 16.6
|
100.4 mmHg
Standard Deviation 13.9
|
102.7 mmHg
Standard Deviation 13.2
|
101.3 mmHg
Standard Deviation 11.8
|
102.1 mmHg
Standard Deviation 13.5
|
Adverse Events
Stimulation
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Stimulation
n=10 participants at risk
Participant will have seated blood pressure monitored without and with transcutaneous stimulation.
DS8R: transcutaneous stimulation of the spinal cord.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Superficial skin burn
|
30.0%
3/10 • Number of events 9 • From enrollment until end of last study visit, up to 30 days.
|
Additional Information
Dr. Jill Maria Wecht
James J Peters VA Medical Center
Phone: (718) 584-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place