Trial Outcomes & Findings for Neuromodulation Techniques After SCI (NCT NCT04241250)
NCT ID: NCT04241250
Last Updated: 2026-04-28
Results Overview
After fitted in the robotic exoskeleton, the participant will be asked to walk for 10-meter distance and the time and speed will be determined. Measurements were conducted over the course of 9 months.
COMPLETED
PHASE2
4 participants
Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)
2026-04-28
Participant Flow
Participant milestones
| Measure |
EAW+SCES
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
EAW+SCES
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Neuromodulation Techniques After SCI
Baseline characteristics by cohort
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
n=2 Participants
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Age, Continuous
|
30.5 years
STANDARD_DEVIATION 8.0 • n=9 Participants
|
33.5 years
STANDARD_DEVIATION 0.70 • n=24 Participants
|
32 years
STANDARD_DEVIATION 5.0 • n=23 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=9 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)Population: Participants in EAW+TS withdrew from the trial before the outcome variables were assessed. In the EAW+SECES, participants had undergone exoskeletal-10 meter walking test at baseline (BL) and after 6 months (P3) from implantation of spinal cord epidural stimulation (SCES). The 10-meter walking test was performed 100% exoskeletal assisted walking (EAW) or reduced EAW (RED-EAW). At post-intervention 3, the RED-EAW was tested twice either with SCES off or with SCES On.
After fitted in the robotic exoskeleton, the participant will be asked to walk for 10-meter distance and the time and speed will be determined. Measurements were conducted over the course of 9 months.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
10-meter Walking Speed (m/Sec)
100%-EAW-NO-SCES-P3
|
0.215 speed (m/sec)
Standard Deviation 0.08
|
—
|
|
10-meter Walking Speed (m/Sec)
RED-EAW-without SCES-P3
|
0.13 speed (m/sec)
Standard Deviation 0.01
|
—
|
|
10-meter Walking Speed (m/Sec)
RED-EAW-with SCES-P3
|
0.13 speed (m/sec)
Standard Deviation 0.01
|
—
|
|
10-meter Walking Speed (m/Sec)
100%-EAW-NO-SCES-BL
|
0.165 speed (m/sec)
Standard Deviation 0.01
|
—
|
PRIMARY outcome
Timeframe: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)Population: Participants in EAW+TS withdrew from the trial before any outcome variables were assessed.
Representative EMG activities of the right VL muscle during the entire gait cycle of the 10 meter walking test at baseline (BL) and post-intervention (PI) measurements over the course of 9 months. In the EAW+SECES, participants had undergone EMG measurements during exoskeletal-10-meter walking test at baseline (BL) and after 6 months (P3) following implantation of spinal cord epidural stimulation (SCES). The EMG tests were performed at 100% exoskeletal assisted walking (EAW) or reduced EAW (RED-EAW) at Baseline and P3. At P3, the EMG tests were performed three times; one at 100%-EAW, RED-EAW without SCES and RED-EAW with SCES.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Muscles Electromyography (EMG) Activity (Micro-volts)
100%-EAW-No SCES-BL
|
0.000045 microvolts
Standard Deviation 0.00004
|
—
|
|
Muscles Electromyography (EMG) Activity (Micro-volts)
RED-EAW-No SCES-BL
|
0.00011085 microvolts
Standard Deviation 0.00013
|
—
|
|
Muscles Electromyography (EMG) Activity (Micro-volts)
RED-EAW-No SCES-P3
|
0.013915 microvolts
Standard Deviation 0.00411
|
—
|
|
Muscles Electromyography (EMG) Activity (Micro-volts)
100%-EAW-No SCES-P3
|
0.0129 microvolts
Standard Deviation 0.002
|
—
|
|
Muscles Electromyography (EMG) Activity (Micro-volts)
RED-EAW-with SCES-P3
|
0.016705 microvolts
Standard Deviation 0.00899
|
—
|
SECONDARY outcome
Timeframe: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)Population: DXA Measurements are reported for percentage FM of total body composition every 3 months. No data collected after Baseline for EAW+TS participants because they withdrew before P1
Body composition will be captured using dual energy x-ray absorptiometry (DXA) to measure fat mass (FM; %) every 3 months during the course of 9-month trial.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
n=2 Participants
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Percentage Fat Mass
Percentage-Fat Mass (FM)-BL
|
25.6 percentage
Standard Deviation 12.2
|
30.1 percentage
Standard Deviation 1.1
|
|
Percentage Fat Mass
Percentage FM-P1
|
23.9 percentage
Standard Deviation 9.8
|
—
|
|
Percentage Fat Mass
Percentage FM-P2
|
20.0 percentage
Standard Deviation 7.1
|
—
|
|
Percentage Fat Mass
Percentage FM-P3
|
22.3 percentage
Standard Deviation 9.0
|
—
|
SECONDARY outcome
Timeframe: [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]Population: Two participants withdrew from the trial. No data collected after Baseline for EAW+TS participants because they withdrew before performing the measurement.
Oxygen uptake during resting, standing and walking will be measured during 6 minutes walking test every 3 months during the course of the trial.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Oxygen Uptake (L/Min)
Baseline
|
1.08 L/min
Standard Deviation 0.72
|
—
|
|
Oxygen Uptake (L/Min)
Post-Intervention 1
|
0.7 L/min
Standard Deviation 0.2
|
—
|
|
Oxygen Uptake (L/Min)
Post-Intervention 3
|
0.84 L/min
Standard Deviation 0.05
|
—
|
SECONDARY outcome
Timeframe: [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]Population: Two participants withdrew from the trial. No data collected after Baseline for EAW+TS participants because they withdrew before performing the measurement.
After overnight fast, blood will be drawn to measure your circulating triglycerides, low and high density lipoproteins and cholesterol.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Fasting Lipid Profile (mg/dl)
BL-Cholesterol
|
158 mg/dl
Standard Deviation 32
|
—
|
|
Fasting Lipid Profile (mg/dl)
P1-Cholesterol
|
142 mg/dl
Standard Deviation 18
|
—
|
|
Fasting Lipid Profile (mg/dl)
P3-Cholesterol
|
137 mg/dl
Standard Deviation 5
|
—
|
|
Fasting Lipid Profile (mg/dl)
BL-triglycerides
|
112 mg/dl
Standard Deviation 27
|
—
|
|
Fasting Lipid Profile (mg/dl)
P1-triglycerides
|
74 mg/dl
Standard Deviation 33
|
—
|
|
Fasting Lipid Profile (mg/dl)
P3-triglycerides
|
75 mg/dl
Standard Deviation 11
|
—
|
SECONDARY outcome
Timeframe: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)Population: DXA Measurements are reported for FFM of total body composition every 3 months. No data collected after Baseline for EAW+TS participants because they withdrew before performing P1 measurement.
Body composition will be captured using dual energy x-ray absorptiometry (DXA) to measure fat mass (FFM; kg) every 3 months during the course of 9-month trial.
Outcome measures
| Measure |
EAW+SCES
n=2 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
n=2 Participants
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Fat-Free Mass
Fat-Free Mass (FFM)-BL
|
52.6 Kg
Standard Deviation 1.7
|
46.5 Kg
Standard Deviation 1.2
|
|
Fat-Free Mass
FFM-P1
|
52.6 Kg
Standard Deviation 1.4
|
—
|
|
Fat-Free Mass
FFM-P2
|
55.0 Kg
Standard Deviation 1.6
|
—
|
|
Fat-Free Mass
FFM-P3
|
55.0 Kg
Standard Deviation 1.5
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: [Time Frame: Baseline (BL), Post-Intervention 1 (P1; 3 months following BL) and Pos-intervention 3 (P3; 6 months following P1)]Population: Two participants withdrew from the EAW+TS group. The second participant in the EAW+SCES requested to withdraw from this exploratory after consulting with the medical monitor personnel of the study.
A multichannel urodynamics system (Laborie) will be used to perform urodynamic studies. A urethral catheter was placed, and saline is infused into the bladder. A pressure transducer was also inserted into the bladder and records pressure during filling. The investigators then measured the volume of the bladder during filling and during emptying.
Outcome measures
| Measure |
EAW+SCES
n=1 Participants
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Volume of Bladder Capacity During Filling and Voiding (ml)
Voided volume-P1
|
75 ml
|
—
|
|
Volume of Bladder Capacity During Filling and Voiding (ml)
Voided volume-P3
|
60 ml
|
—
|
|
Volume of Bladder Capacity During Filling and Voiding (ml)
Voided volume-BL
|
50 ml
|
—
|
Adverse Events
EAW+SCES
EAW+TS
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EAW+SCES
n=2 participants at risk
Three months of exoskeleton training followed by 6 months of epidural stimulation.
EAW+SCES (exoskelton and spinal cord epidural stimulation): Three months of exoskeleton training followed by 6 months of epidural stimulation.
|
EAW+TS
n=2 participants at risk
Three months of exoskeleton training followed by 6 months of transspinal stimulation.
EAW+TS (exoskelton and transspinal stimulation): Three months of exoskeleton training followed by 6 months of transspinal stimulation.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Ankle Sprain
|
0.00%
0/2 • every week during the course of the trial-9 months
Not different
|
50.0%
1/2 • Number of events 1 • every week during the course of the trial-9 months
Not different
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place