Spinal Cord InjuryNCT02862080
Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI
A study testing cathode tsDCS, Ekso and anode tsDCS in people with Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- cathode tsDCS, Ekso and anode tsDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to 17 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Weight <220 pounds
- Intact skin on all surfaces in contact with device and load bearing surfaces
- Ability to perform informed consent
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NeuroRecovery Research Center at TIRR Memorial Hermann
Houston, Texas, 77030
About this study
Official title: Impact of Combining tsDCS and Robotic Exoskeleton Gait Training on Spinal Excitability and Gait Function in Individuals With SCI
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.
Read the 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.
- Conditions
- Spinal Cord Injury
- Being tested
- cathode tsDCS, Ekso, anode tsDCS
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cathode tsDCSDevice
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.
EksoDevice
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
anode tsDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso | Experimental | 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. Receives: Device: cathode tsDCS; Device: Ekso |
| no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso | Experimental | 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. Receives: Device: cathode tsDCS; Device: Ekso |
| no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso | Experimental | 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. Receives: Device: Ekso; Device: anode tsDCS |
| no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso | Experimental | 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. Receives: Device: Ekso; Device: anode tsDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: beginning and end of first no-intervention visit (7 days before any 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
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.
Measured: beginning and end of second no-intervention visit (3 days before any 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
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.
Measured: before and after intervention on day 1
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.
Measured: before and after intervention on day 5
Secondary outcomes (7)
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.
Measured: first no-intervention visit (7 days before any intervention)
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.
Measured: second no-intervention visit (3 days before any intervention)
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.
Measured: Day 1 of intervention
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.
Measured: Day 2 of intervention
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.
Measured: Day 3 of intervention
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.
Measured: Day 4 of intervention
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.
Measured: Day 5 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start13 Feb 2017
- Primary completion17 Nov 2017
- Study completion17 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR Memorial Hermann
- Responsible party
- Principal investigator, Marcie Kern, The University of Texas Health Science Center, Houston
- Investigators
- Marcie Kern, PT, MSPT, Principal investigator, TIRR Memorial Hermann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862080
- Sponsor's protocol ID
- HSC-MS-16-0329
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2016
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Combining tsDCS and Robotic Exoskeleton Gait Training on Spinal Excitability and Gait Function in Individuals With SCI
- ClinicalTrials.gov ID
- NCT02862080
- Acronym / sponsor ID
- HSC-MS-16-0329
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- TIRR Memorial Hermann
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- 17 Nov 2017 (actual)
- Study completion
- 17 Nov 2017 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso | Experimental | Device: cathode tsDCS, Device: EksoNon-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. |
| no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso | Experimental | Device: cathode tsDCS, Device: EksoNon-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. |
| no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso | Experimental | Device: Ekso, Device: anode tsDCSNon-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. |
| no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso | Experimental | Device: Ekso, Device: anode tsDCSNon-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cathode tsDCSNon-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. | Device | no intervention; then no intervention; then Ekso; then cathode tsDCS + Ekso; then Ekso, no intervention; then no intervention; then cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso |
| EksoEkso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking. | Device | no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then 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 cathode tsDCS + Ekso; then Ekso; then cathode tsDCS+Ekso |
| anode tsDCSNon-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. | Device | no intervention; then no intervention; then Ekso; then anode tsDCS + Ekso; then Ekso, no intervention; then no intervention; then anode tsDCS + Ekso; then Ekso; then anode tsDCS + Ekso |
Primary outcome
Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Time frame: 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
Time frame: 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.
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
Time frame: before and after intervention on day 1
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
Time frame: before and after intervention on day 5
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.
7 secondary outcomes
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: first no-intervention visit (7 days before any intervention)
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: second no-intervention visit (3 days before any intervention)
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: Day 1 of intervention
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: Day 2 of intervention
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: Day 3 of intervention
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: Day 4 of intervention
Gait Speed as Assessed by 10 Meter Walk Test
Time frame: Day 5 of intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcie Kern, PT, MSPT principal investigator
TIRR Memorial Hermann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cathode tsDCS, Ekso and anode tsDCS in people with Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session (time frame: beginning and end of first no-intervention visit (7 days before any intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.