Back to resultsCombining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cathode tsDCS
Ekso
anode tsDCS
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility Criteria
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
Sites / Locations
- NeuroRecovery Research Center at TIRR Memorial Hermann
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso
no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso
no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso
no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso
Arm Description
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin. Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02862080
First Posted
June 10, 2016
Last Updated
January 15, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
TIRR Memorial Hermann
1. Study Identification
Unique Protocol Identification Number
NCT02862080
Brief Title
Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI
Official Title
Impact of Combining tsDCS and Robotic Exoskeleton Gait Training on Spinal Excitability and Gait Function in Individuals With SCI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
November 17, 2017 (Actual)
Study Completion Date
November 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
TIRR Memorial Hermann
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso
Arm Type
Experimental
Arm Description
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Arm Title
no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso
Arm Type
Experimental
Arm Description
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Arm Title
no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso
Arm Type
Experimental
Arm Description
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Arm Title
no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso
Arm Type
Experimental
Arm Description
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Intervention Type
Device
Intervention Name(s)
cathode tsDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Ekso
Intervention Description
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Intervention Type
Device
Intervention Name(s)
anode tsDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Description
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)
Title
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Description
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)
Title
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Description
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
Title
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Description
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
Secondary Outcome Measure Information:
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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)
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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)
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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
Title
Gait Speed as Assessed by 10 Meter Walk Test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcie Kern, PT, MSPT
Organizational Affiliation
TIRR Memorial Hermann
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroRecovery Research Center at TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI
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