Spinal Cord Injury
Conditions
Brief summary
The purpose of the study is to determine whether transcutaneous spinal direct current stimulation (tsDCS) is safe for individuals with spinal cord injury (SCI). tsDCS is an electrical current applied to the skin. The plan is to also study the potential neurophysiological changes (changes in speed and excitability of the nerves) and functional improvements in gait (for example, gait quality, speed and walking distance) for individuals with SCI after combined application of tsDCS and exoskeleton assisted gait training.
Detailed description
Subjects will participate in two baseline visits, 4 days apart. Each baseline visit will last 1 hour and will include assessment of soleus H-Reflex and 10 meter walk test on arrival and 40 minutes after the initial assessment. Subjects will be asked to minimize their activity between assessments by either sitting in a chair or lying on a mat. Each training visit will involve either an exoskeleton intervention or a combined exoskeleton and tsDCS intervention. Each training visit will include assessment of soleus H-Reflex and 10 meter walk test before and after the exoskeleton intervention or before and after the combined exoskeleton and tsDCS intervention.
Interventions
DEVICEcathode tsDCS
Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
DEVICEEkso
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
DEVICEanode tsDCS
Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
Sponsors
TIRR Memorial Hermann
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female * ≥18 years of age * Able to achieve adequate fit within exoskeleton * Diagnosis of spinal cord injury (SCI), T10 level and above (T11 and 12 may participate if no clinical signs of lower motor neuron lesion present) * Minimum of 6 months post injury * Sufficient range of motion to attain normal, reciprocal gait pattern, and transition from normal sit to stand or stand to sit * Weight \<220 pounds * Intact skin on all surfaces in contact with device and load bearing surfaces * Ability to perform informed consent
Exclusion criteria
* Pregnancy * Spinal instability * Unhealed limb or pelvic fractures or any condition restricting weight bearing in limbs * Presence of peripheral neuropathy or any pathology that could influence reflex excitability * Diagnosis of other neurological injury other than SCI such as stroke/cerebrovascular accident (CVA), multiple sclerosis (MS), acquired brain injury (ABI), cerebral palsy (CP) * Uncontrolled spasticity (≥3 on Modified Ashworth Scale) * Colostomy * Decreased range of motion or contractures in legs (\>10° at hips, knees or ankles) * Uncontrolled autonomic dysreflexia * Unresolved deep vein thrombosis * Inability to tolerate standing due to cardiovascular issues or orthostatic hypotension * Severe comorbidities: active infections, heart, lung, or circulatory conditions * Pressure sores, impaired skin integrity * Use of mechanical ventilation for respiratory support * Presence of any of the following contraindications to electrical stimulation: cardiac pacemaker, deep brain stimulator, or evidence of cancerous (malignant) tissue * Presence of metal in thoracic spine or region of electrode placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | beginning and end of first no-intervention visit (7 days before any intervention) | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. |
| Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | beginning and end of second no-intervention visit (3 days before any intervention) | This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed as Assessed by 10 Meter Walk Test | first no-intervention visit (7 days before any intervention) | The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ekso Alone, and Ekso + Cathode tsDCS Participants received Ekso alone and also Ekso combined with cathode non-invasive transcutaneous spinal direct current stimulation (tsDCS).
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso alone will consist of a walking session in Ekso with no tsDCS. Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso. | 2 |
| Ekso Alone, and Ekso + Anode tsDCS Participants received Ekso alone and also Ekso combined with anode non-invasive transcutaneous spinal direct current stimulation (tsDCS).
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso alone will consist of a walking session in Ekso with no tsDCS. Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso. | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | Ekso Alone, and Ekso + Cathode tsDCS | Ekso Alone, and Ekso + Anode tsDCS | Total |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 12.7 | 37 years STANDARD_DEVIATION 9.9 | 39.5 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Level of Spinal Cord Injury (SCI) C5 | 1 Participants | 1 Participants | 2 Participants |
| Level of Spinal Cord Injury (SCI) T1 | 1 Participants | 0 Participants | 1 Participants |
| Level of Spinal Cord Injury (SCI) T9 | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment United States | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
| Time since injury | 16.5 years STANDARD_DEVIATION 16.26 | 6 years STANDARD_DEVIATION 1.41 | 11.25 years STANDARD_DEVIATION 11.21 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 2 | 0 / 2 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Time frame: beginning and end of second no-intervention visit (3 days before any intervention)
Population: All participants were assessed for the H-Reflex at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | -5.74 percent change in H-Reflex | Standard Deviation 10.96 |
Primary
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Time frame: before and after intervention on day 1
Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | 4.52 percent change in H-Reflex | Standard Deviation 6.47 |
| Anode tsDCS + Ekso | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | 11.19 percent change in H-Reflex | Standard Deviation 37.94 |
| Ekso Alone | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | 2.71 percent change in H-Reflex | Standard Deviation 13.06 |
Primary
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Time frame: before and after intervention on day 5
Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | -2.30 percent change in H-Reflex | Standard Deviation 2.65 |
| Anode tsDCS + Ekso | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | -7.44 percent change in H-Reflex | Standard Deviation 24.82 |
| Ekso Alone | Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | -9.82 percent change in H-Reflex | Standard Deviation 9.73 |
Primary
Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Time frame: beginning and end of first no-intervention visit (7 days before any intervention)
Population: All participants were assessed for the H-Reflex at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session | -3.13 percent change in H-Reflex | Standard Deviation 18.27 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: Day 2 of intervention
Population: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 24.28 seconds | Standard Deviation 0 |
| Anode tsDCS + Ekso | Gait Speed as Assessed by 10 Meter Walk Test | 37.53 seconds | Standard Deviation 17.18 |
| Ekso Alone | Gait Speed as Assessed by 10 Meter Walk Test | 24.21 seconds | Standard Deviation 13.01 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: Day 3 of intervention
Population: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one period of the the Ekso alone arm. Another participant was not assessed for gait speed for one period of the the anode tsDCS+Ekso arm. For the cathode tsDCS+Ekso arm, 1 received intervention once (1 data point). For the anode tsDCS+Ekso arm, 2 received intervention once (2 data points). For the Ekso alone arm, 1 received intervention once, and 2 received it twice (5 data points).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 16.42 seconds | Standard Deviation 0 |
| Anode tsDCS + Ekso | Gait Speed as Assessed by 10 Meter Walk Test | 26.85 seconds | Standard Deviation 15.07 |
| Ekso Alone | Gait Speed as Assessed by 10 Meter Walk Test | 22.98 seconds | Standard Deviation 9.62 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: Day 4 of intervention
Population: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 17.79 seconds | Standard Deviation 0 |
| Anode tsDCS + Ekso | Gait Speed as Assessed by 10 Meter Walk Test | 38.43 seconds | Standard Deviation 19.06 |
| Ekso Alone | Gait Speed as Assessed by 10 Meter Walk Test | 21.92 seconds | Standard Deviation 7.87 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: Day 5 of intervention
Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for Gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 39.38 seconds | Standard Deviation 17.82 |
| Anode tsDCS + Ekso | Gait Speed as Assessed by 10 Meter Walk Test | 35.35 seconds | Standard Deviation 18.51 |
| Ekso Alone | Gait Speed as Assessed by 10 Meter Walk Test | 26.43 seconds | Standard Deviation 12.93 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: first no-intervention visit (7 days before any intervention)
Population: All participants were assessed for the 10MWT at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 37.14 seconds | Standard Deviation 20.25 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: second no-intervention visit (3 days before any intervention)
Population: One participant was not assessed for gait speed at this visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 27.20 seconds | Standard Deviation 12.2 |
Secondary
Gait Speed as Assessed by 10 Meter Walk Test
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Time frame: Day 1 of intervention
Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Intervention | Gait Speed as Assessed by 10 Meter Walk Test | 38.37 seconds | Standard Deviation 14.47 |
| Anode tsDCS + Ekso | Gait Speed as Assessed by 10 Meter Walk Test | 41.64 seconds | Standard Deviation 21.34 |
| Ekso Alone | Gait Speed as Assessed by 10 Meter Walk Test | 30.47 seconds | Standard Deviation 20.43 |