Trial Outcomes & Findings for Spinal Excitation to Enhance Mobility (NCT NCT03667573)
NCT ID: NCT03667573
Last Updated: 2023-09-13
Results Overview
Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Measured at session 2 (2 days after the baseline session)
Results posted on
2023-09-13
Participant Flow
Study advertisements were mailed to patients of the North Florida/South Georgia Veterans Health System using a mailing list generated by the VA Informatics and Computing Infrastructure. Inclusion criteria for recruitment mailings included age 65 or greater, primary residence in a local zip code, and absence of major medical conditions (based on ICD-9/ICD-10 codes). A screening questionnaire was used to interview individuals by telephone prior to scheduling an onsite screening visit.
Participants were excluded if they had major health conditions that would affect their safety in the study and/or their ability to perform the study procedures (e.g., ability to walk independently). Other exclusion criteria were excessive body mass index, major somatosensory impairment of the feet, and use of medications affecting the central nervous system.
Participant milestones
| Measure |
tsDCS Dosage A and Textured Insoles
tsDCS dosage "A" and textured shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage B and Textured Insoles
tsDCS dosage "B" and textured shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage A and Smooth Insoles
tsDCS dosage "A" and smooth shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
|
tsDCS Dosage B and Smooth Insoles
tsDCS dosage "B" and smooth shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
5
|
7
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spinal Excitation to Enhance Mobility
Baseline characteristics by cohort
| Measure |
tsDCS Dosage A and Textured Insoles
n=6 Participants
tsDCS dosage "A" and textured shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage B and Textured Insoles
n=5 Participants
tsDCS dosage "B" and textured shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage A and Smooth Insoles
n=5 Participants
tsDCS dosage "A" and smooth shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
|
tsDCS Dosage B and Smooth Insoles
n=7 Participants
tsDCS dosage "B" and smooth shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
77.2 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
75.8 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
79.3 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
77.7 years
STANDARD_DEVIATION 7.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Corrected walking speed
|
0.850 meters/second
STANDARD_DEVIATION .478 • n=5 Participants
|
.887 meters/second
STANDARD_DEVIATION .272 • n=7 Participants
|
.819 meters/second
STANDARD_DEVIATION .388 • n=5 Participants
|
.913 meters/second
STANDARD_DEVIATION .591 • n=4 Participants
|
.871 meters/second
STANDARD_DEVIATION .435 • n=21 Participants
|
PRIMARY outcome
Timeframe: Measured at session 2 (2 days after the baseline session)Fastest safe walking speed over the complex walking course (measured as changed between the baseline and follow-up sessions)
Outcome measures
| Measure |
tsDCS Dosage A and Textured Insoles
n=6 Participants
tsDCS dosage "A" and textured shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage B and Textured Insoles
n=5 Participants
tsDCS dosage "B" and textured shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage A and Smooth Insoles
n=5 Participants
tsDCS dosage "A" and smooth shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
|
tsDCS Dosage B and Smooth Insoles
n=7 Participants
tsDCS dosage "B" and smooth shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
|
|---|---|---|---|---|
|
Walking Speed Change From Baseline
|
.054 meters/second
Standard Deviation .054
|
.078 meters/second
Standard Deviation .04
|
.085 meters/second
Standard Deviation .04
|
.039 meters/second
Standard Deviation .12
|
SECONDARY outcome
Timeframe: Measured at session 2 (2 days after the baseline session)Prefrontal brain activity while walking at fastest safe walking speed over the complex walking course (measured by fNIRS as change between baseline and follow-up session)
Outcome measures
| Measure |
tsDCS Dosage A and Textured Insoles
n=6 Participants
tsDCS dosage "A" and textured shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage B and Textured Insoles
n=5 Participants
tsDCS dosage "B" and textured shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
textured shoe insoles: textured shoe insoles
|
tsDCS Dosage A and Smooth Insoles
n=5 Participants
tsDCS dosage "A" and smooth shoe insoles
tsDCS Dosage (A): mild electrical stimulation delivered to lumbosacral spinal cord
|
tsDCS Dosage B and Smooth Insoles
n=7 Participants
tsDCS dosage "B" and smooth shoe insoles
tsDCS Dosage (B): mild electrical stimulation delivered to lumbosacral spinal cord
|
|---|---|---|---|---|
|
Prefrontal fNIRS Change From Baseline
|
-1.21 microMolar
Standard Deviation 0.93
|
0.24 microMolar
Standard Deviation 1.15
|
0.14 microMolar
Standard Deviation 0.47
|
0.17 microMolar
Standard Deviation 0.62
|
Adverse Events
tsDCS Dosage A and Textured Insoles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tsDCS Dosage B and Textured Insoles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tsDCS Dosage A and Smooth Insoles
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
tsDCS Dosage B and Smooth Insoles
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