Trial Outcomes & Findings for Stimulation to Enhance Walking Post-SCI (NCT NCT03702842)
NCT ID: NCT03702842
Last Updated: 2025-03-13
Results Overview
Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline; Week 4
Results posted on
2025-03-13
Participant Flow
Enrolled individuals were initially assigned to the 'Immediate effects' group. After completion of this arm, the same individuals were randomly assigned to either the Higher dosage or lower dosage interventional group (n=4 per group) Thus, only 8 individuals started and completed all procedures.
Participant milestones
| Measure |
Part 1: Immediate Effects: tsDCS Lower Dose First, Then Higher Dose
lower dosage tsDCS using the Soterix Medical tsDCS stimulator followed by higher dosage tsDCS. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
|
Part 2: Interventional Effects - Lower Dosage
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Part 2: Interventional Effects - Higher Dosage
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
|---|---|---|---|
|
Part 1 Immediate Effects tsDCS Lower
STARTED
|
8
|
0
|
0
|
|
Part 1 Immediate Effects tsDCS Lower
COMPLETED
|
8
|
0
|
0
|
|
Part 1 Immediate Effects tsDCS Lower
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 1 Immediate Effects tsDCS Higher
STARTED
|
8
|
0
|
0
|
|
Part 1 Immediate Effects tsDCS Higher
COMPLETED
|
8
|
0
|
0
|
|
Part 1 Immediate Effects tsDCS Higher
NOT COMPLETED
|
0
|
0
|
0
|
|
Part 2 Interventional - Randomized
STARTED
|
0
|
4
|
4
|
|
Part 2 Interventional - Randomized
COMPLETED
|
0
|
4
|
4
|
|
Part 2 Interventional - Randomized
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stimulation to Enhance Walking Post-SCI
Baseline characteristics by cohort
| Measure |
Interventional Effects: Lower Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Interventional Effects: Higher Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
53 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
52 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 4Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.
Outcome measures
| Measure |
Interventional Effects: Higher Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Interventional Effects: Lower Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
|---|---|---|
|
Change in 10-Meter Walk Test (Interventional)
|
0.18 meters/second
Standard Deviation 0.29
|
-0.05 meters/second
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Baseline; 1 hourThe change in normalized amplitude of muscle activation recorded from the right ankle plantar flexor muscles (soleus and gastrocnemius) will be reported. EMGs will be recorded during speed-matched trials during walking on a treadmill. The normalized mean activation during single limb stance will be quantified for each step and averaged. For each participant, the change in activation will be quantified by subtracting activation pre training from post-training activation. The mean change and standard deviation of change will be reported for each group.
Outcome measures
| Measure |
Interventional Effects: Higher Dosage
n=8 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Interventional Effects: Lower Dosage
n=8 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
|---|---|---|
|
Change in Plantar Flexor Muscle Electromyogram Activation During Walking (Immediate Effects)
|
0.0102 mV
Standard Deviation 0.1091
|
-0.0023 mV
Standard Deviation 0.1257
|
SECONDARY outcome
Timeframe: Baseline; Week 4The 6-Minute Walk Test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
Outcome measures
| Measure |
Interventional Effects: Higher Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Interventional Effects: Lower Dosage
n=4 Participants
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
|---|---|---|
|
Change in 6-Minute Walk Test (Interventional)
|
36.4 meters
Standard Deviation 69
|
4.9 meters
Standard Deviation 56.9
|
Adverse Events
Part 1: Immediate Effects: tsDCS Lower Dose First, Then Higher Dose
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Interventional Effects - Higher Dosage
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Interventional Effects - Lower Dosage
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Immediate Effects: tsDCS Lower Dose First, Then Higher Dose
n=8 participants at risk
lower dosage tsDCS using the Soterix Medical tsDCS stimulator followed by higher dosage tsDCS. During each session, participants will be asked to walk for up to 30 minutes on a treadmill while the stimulation is delivered. Assessments will be completed before and after the bout of treadmill walking.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
|
Part 2: Interventional Effects - Higher Dosage
n=4 participants at risk
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the higher dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the higher dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
Part 2: Interventional Effects - Lower Dosage
n=4 participants at risk
After completing the 2 sessions of the first part of the study, the participants will be randomized to two groups for the second part of the study. Those in the lower dosage group will receive 16 sessions of locomotor training with tsDCS stimulation applied at the lower dosage for up to 30 minutes using the Soterix Medical tsDCS stimulator. The training sessions will be scheduled 4 days per week for 4 weeks. All training will be overseen by a physical therapist with experience in SCI walking rehabilitation and will involve the use of an overhead support harness.
Soterix Medical tsDCS stimulator: tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
Locomotor training: Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin abrasion or lesion
|
0.00%
0/8 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
75.0%
3/4 • Number of events 5 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
25.0%
1/4 • Number of events 1 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
|
Musculoskeletal and connective tissue disorders
muscle tightness or spasm
|
0.00%
0/8 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
75.0%
3/4 • Number of events 5 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
0.00%
0/4 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
|
Musculoskeletal and connective tissue disorders
pain/discomfort
|
0.00%
0/8 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
50.0%
2/4 • Number of events 2 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
75.0%
3/4 • Number of events 3 • eight weeks
Adverse events were collected in accordance with the definition used by clinicaltrials.gov. Additionally, participants were monitored during all study sessions using a standardized questionnaire and asked to report changes in health and function status.
|
Additional Information
Emily J Fox, Research Associate Professor
University of Florida
Phone: 352-273-6085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place