Spinal Cord InjuriesNCT04043715
Comparison of Transcutaneous and Epidural Spinal Stimulation for Improving Function
A study testing Transcutaneous spinal stimulation and Epidural spinal stimulation in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Washington at 1 site in United States.
Trial summary
Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Central Nervous System Diseases
- What is being tested?
- Transcutaneous spinal stimulation and Epidural spinal stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have a spinal cord injury at least one-year duration;
- are between 21 and 70 years of age;
- have difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing);
- are candidates for an implanted stimulator;
- are willing and able to have surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline;
- experience chronic pain;
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- are in stable medical condition without cardiopulmonary disease or frequent autonomic dysreflexia that would contraindicate participation in lower extremity rehabilitation or testing activities;
- are capable of performing simple cued motor tasks;
- have the ability to attend 3-5 sessions per week physical therapy sessions and testing activities over three months;
- have adequate social support to be able to participate in assessment sessions occurring between once per week to once per month for up to 9 months;
- are volunteering to be involved in this study;
- are cleared for gait training by primary physician of the subject;
- and have ability to read and speak English
Who cannot join
- have autoimmune etiology of spinal cord dysfunction/injury;
- have a history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.;
- have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.);
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
- have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation;
- have active cancer;
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- have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention;
- have unhealed fracture, contracture, pressure sore, or urinary tract infection or other illnesses that might interfere with lower extremity rehabilitation or testing activities;
- have any condition that would render the patient unable to safely cooperate with the study tests as judged by the screening physician;
- are pregnant;
- are dependent on ventilation support;
- have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc.);
- have depression or anxiety based on the Center for Epidemiologic Studies Depression Scale (CESD) (score >16/60) and General Anxiety Disorder-7 item Questionnaire (score >9/21), respectively.
- have alcohol and/or drug abuse;
- have cognitive impairment based on Short Portable Mental Status Questionnaire (SPMSQ) (score >2/10);
- are unable to read and/or comprehend the consent form;
- are unable to understand the instructions given as part of the study;
- have established osteoporosis and are taking medication for osteoporosis treatment;
- have bone mineral density T scores ≤ -2.0 in anteroposterior lumbar spine and/or proximal femur measured by DEXA (if participants are clear for other criteria and have not been examined by DEXA at the screening, we will ask participants to undergo DEXA to reveal any risk of weight bearing activity);
- have a low-energy fracture history before or after spinal cord injury;
- have a history of orthopedic surgery in lower extremities that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, etc.);
- have fixed lower extremity joint contractures;
- are taller than 80 inches and/or weighs more than 350 pounds (due to the limitation of the experimental equipment such as the body weight support system);
- lack the ability to fully comprehend and/or perform study procedures in the investigator's opinion/judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spinal Stimulation for Standing & Walking; Comparison of Transcutaneous & Epidural Stimulation
Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback.
Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function.
In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.
Read the detailed description
The purpose of this study is to determine the optimal method for delivering spinal stimulation to improve walking in people with incomplete spinal cord injury. By directly comparing non-invasive transcutaneous (TransQ) stimulation with implanted epidural stimulation, investigators hope to guide the field toward the most beneficial method for restoration of lower extremity function. In addition, the investigators may identify subgroups of people that respond better to each type of stimulation, informing personalized treatment for people with different types of spinal cord injury. The research team will explore the following specific aims:
Aim 1: Evaluate the improvements in lower extremity and autonomic function via transcutaneous spinal stimulation and intensive physical therapy for people with chronic SCI.
Aim 2: Quantify additional improvements in lower extremity and autonomic function via epidural spinal stimulation and intensive physical therapy for people with chronic SCI.
The investigators will test the hypothesis that epidural stimulation leads to greater improvements than an equal dose of transcutaneous stimulation. To compare these 2 stimulation methods the study team will evaluate voluntary control of muscle activity via EMG and kinematic parameters of locomotion, as well as improvements in bladder and other autonomic functions and overall quality of life.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Wounds and Injuries
- Being tested
- Transcutaneous spinal stimulation, Epidural spinal stimulation
- Keywords
- transcutaneous spinal stimulation, epidural spinal stimulation, physical therapy, lower extremity
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal stimulationDevice
Also called Physical Therapy
Physical therapy to improve standing and walking
Epidural spinal stimulationDevice
Also called Physical Therapy
Physical therapy to improve standing and walking
| Study group | Role | What they receive |
|---|---|---|
| Comparison of transcutaneous & epidural stimulation | Other | Comparison of transcutaneous vs epidural electrical stimulation Receives: Device: Transcutaneous spinal stimulation; Device: Epidural spinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Recovery Scale
Neuromuscular recovery scale is an assessment for sitting, standing and walking functions based on a comparison to pre-injury performance criteria or how a task was performed one day prior to spinal cord injury and without use of compensation strategies. The items consists of stand retraining, stand adaptability, step retraining, step adaptability, sit, reverse sit up, trunk extension in sitting, sit to stand , stand, walking, and upper limb functions. They are score the scale of 4 based on how close to the function in the pre-injured condition.
Measured: 8-11 months
Secondary outcomes (15)
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Standard neurologic examination that is routinely used to determine the levels and severity of spinal cord injury. Includes manual muscle strength testing and dermatomal light touch and pin prick sensory examination.
Measured: 8-11 months
Somatosensory evoked potentials
Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the scalp following electrical stimulation of peripheral nerve from the wrist. The amplitude of the response is reported in micro-volts.
Measured: 8-11 months
Motor evoked potentials - Latency
Measurement of latency of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The latency of the response is reported in micro-seconds.
Measured: 8-11 months
Motor evoked potentials - Amplitude
Measurement of amplitude of electrical potentials that is recorded by surface electrodes over the skin of limb muscles following spinal stimulation or magnetic stimulation of brain over the scalp. The amplitude of the response is reported in micro-volts.
Measured: 8-11 months
Berg Balance Test
Measurement of balance in standing and sitting. The balance score consists of 14 items and is reported in the scale of 56 (each items are score in 0-4).
Measured: 8-11 months
Six-minute walk test
Measurement of walking ability. The distance is reported in meter.
Measured: 8-11 months
Ten-minute walk test
Measurement of walking ability. The walking speed is reported in meter per second.
Measured: 8-11 months
Kinetic and kinematic gait analysis using 3D camera system - angle
Measurement of leg function and walking ability. Joint angle is reported in degree angle.
Measured: 8-11 months
Kinetic and kinematic gait analysis using 3D camera system - velocity
Measurement of leg function and walking ability. Velocity is reported in meter per second.
Measured: 8-11 months
Electromyography recording of LE and trunk muscles
Measurement of muscle and nerve functions. The muscle activities are reported in micro-volts.
Measured: 8-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
Patient reported quality of life scale. The SCI-QOL consists of 19 item banks, and is reported by T-score comparing the mean of the functional level in the population.
Measured: 8-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
Patient reported functional scale. The SCI-QOL consists of 10 item banks, and is reported by T-score comparing the mean of the functional level in the population.
Measured: 8-11 months
Wartenberg Pendulum Test
The Wartenberg Pendulum Test is a measure of spastic hypertonia. Using computer data for number of oscillations and amplitude, values of the Relaxation index (R1 and R2) are calculated and compared to norms.
Measured: 8-11 months
Walking Index for Spinal Cord Injury II
A functional capacity scale designed to measure improvements in ambulation in persons with spinal cord injury, by evaluating the amount of physical assistance, braces or devices required to walk 10 meters.
Measured: 8-11 months
Neurogenic Bladder Symptom Score
24-item questionnaire designed to assess bladder symptoms in patients with neurogenic bladder dysfunction as a result of spinal cord injury, multiple sclerosis, and spinal bifida.
Measured: 8-11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Aug 2019
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Why it stopped: No funding. PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study will compare the benefits of transcutaneous and epidural stimulation in individuals with SCI through a phased intervention program including: 1) baseline testing, 2) PT only, 3) PT + TransQ stimulation, 4) wash out/recovery, 5) PT + Epidural stimulation, 6) follow-up testing.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Principal investigator, Chet Moritz, University of Washington
- Investigators
- Rajiv Saigal, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043715
- Sponsor's protocol ID
- STUDY00004478
- Other IDs
- EEC-1028725
- Status last verified
- Apr 2024
- First submitted
- 31 Jul 2019
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Stimulation for Standing & Walking; Comparison of Transcutaneous & Epidural Stimulation
- ClinicalTrials.gov ID
- NCT04043715
- Acronym / sponsor ID
- STUDY00004478
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Central Nervous System Diseases, Nervous System Diseases, Trauma, Nervous System, Wounds and Injuries
- Keywords
- transcutaneous spinal stimulation, epidural spinal stimulation, physical therapy, lower extremity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding. PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incomplete spinal cord injuries (SCI) are the most frequent neurologic category, comprising 66.7% of all SCI cases. People with incomplete SCI may retain some ability to move the legs and therefore the capacity to regain walking. Studies that show functional improvement in locomotion via electrical stimulation of lumbosacral circuits suggest that the underlying mechanisms are neuromodulation of lumbosacral spinal cord automaticity and sensory feedback.
Both epidural and transcutaneous spinal stimulation are demonstrating exciting potential to improve limb function for people after chronic SCI. Available treatment options for SCI are less than satisfactory and most often do not achieve full restoration of function. Recent experimental results suggest an exciting new approach of using electrical spinal stimulation to enable users to regain control of their weak or paralyzed muscles. Using surgically-implanted electrodes, epidural stimulation results in remarkable improvements of lower extremity function as well as autonomic functions such as bladder function and sexual function.
In addition to epidural stimulation, over only the last few years a novel strategy of skin surface electrical spinal stimulation has also demonstrated exciting potential for improving walking function. Using a high-frequency stimulation pulse, current can pass through the skin without discomfort and activate the spinal cord; this results in patterned stepping movements for people without SCI and improved lower extremity function following SCI. This study will directly compare skin-surface transcutaneous stimulation with implanted epidural stimulation for improving lower extremity function.
Detailed description
The purpose of this study is to determine the optimal method for delivering spinal stimulation to improve walking in people with incomplete spinal cord injury. By directly comparing non-invasive transcutaneous (TransQ) stimulation with implanted epidural stimulation, investigators hope to guide the field toward the most beneficial method for restoration of lower extremity function. In addition, the investigators may identify subgroups of people that respond better to each type of stimulation, informing personalized treatment for people with different types of spinal cord injury. The research team will explore the following specific aims:
Aim 1: Evaluate the improvements in lower extremity and autonomic function via transcutaneous spinal stimulation and intensive physical therapy for people with chronic SCI.
Aim 2: Quantify additional improvements in lower extremity and autonomic function via epidural spinal stimulation and intensive physical therapy for people with chronic SCI.
The investigators will test the hypothesis that epidural stimulation leads to greater improvements than an equal dose of transcutaneous stimulation. To compare these 2 stimulation methods the study team will evaluate voluntary control of muscle activity via EMG and kinematic parameters of locomotion, as well as improvements in bladder and other autonomic functions and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will compare the benefits of transcutaneous and epidural stimulation in individuals with SCI through a phased intervention program including: 1) baseline testing, 2) PT only, 3) PT + TransQ stimulation, 4) wash out/recovery, 5) PT + Epidural stimulation, 6) follow-up testing.
| Arm | Type | Receives |
|---|---|---|
| Comparison of transcutaneous & epidural stimulation | Other | Device: Transcutaneous spinal stimulation, Device: Epidural spinal stimulationComparison of transcutaneous vs epidural electrical stimulation |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- have a spinal cord injury at least one-year duration;
- are between 21 and 70 years of age;
- have difficulty with leg functions and mobility in activities of daily living (e.g. walking, transferring surface to surface, standing);
- are candidates for an implanted stimulator;
- are willing and able to have surgical implantation of the epidural stimulator for the treatment of pain according to the study timeline;
Key exclusion criteria (24 listed)
- have autoimmune etiology of spinal cord dysfunction/injury;
- have a history of additional neurologic disease, such as stroke, MS, traumatic brain injury, etc.;
- have peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy, etc.);
- have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.);
- have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation;
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 |
|---|---|---|
| Transcutaneous spinal stimulationAlso: Physical TherapyPhysical therapy to improve standing and walking | Device | Comparison of transcutaneous & epidural stimulation |
| Epidural spinal stimulationAlso: Physical TherapyPhysical therapy to improve standing and walking | Device | Comparison of transcutaneous & epidural stimulation |
Primary outcome
Neuromuscular Recovery Scale
Time frame: 8-11 months
Neuromuscular recovery scale is an assessment for sitting, standing and walking functions based on a comparison to pre-injury performance criteria or how a task was performed one day prior to spinal cord injury and without use of compensation strategies. The items consists of stand retraining, stand adaptability, step retraining, step adaptability, sit, reverse sit up, trunk extension in sitting, sit to stand , stand, walking, and upper limb functions. They are score the scale of 4 based on how close to the function in the pre-injured condition.
15 secondary outcomes
International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Examination
Time frame: 8-11 months
Somatosensory evoked potentials
Time frame: 8-11 months
Motor evoked potentials - Latency
Time frame: 8-11 months
Motor evoked potentials - Amplitude
Time frame: 8-11 months
Berg Balance Test
Time frame: 8-11 months
Six-minute walk test
Time frame: 8-11 months
Ten-minute walk test
Time frame: 8-11 months
Kinetic and kinematic gait analysis using 3D camera system - angle
Time frame: 8-11 months
Kinetic and kinematic gait analysis using 3D camera system - velocity
Time frame: 8-11 months
Electromyography recording of LE and trunk muscles
Time frame: 8-11 months
Spinal Cord Injury - Quality of Life (SCI-QOL) questionnaire
Time frame: 8-11 months
Spinal Cord Injury - Functional Index (SCI-FI) questionnaire
Time frame: 8-11 months
Wartenberg Pendulum Test
Time frame: 8-11 months
Walking Index for Spinal Cord Injury II
Time frame: 8-11 months
Neurogenic Bladder Symptom Score
Time frame: 8-11 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Rajiv Saigal, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal stimulation and Epidural spinal stimulation in people with Spinal Cord Injuries and Spinal Cord Diseases, run by University of Washington 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 13 inclusion and 24 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: withdrawn, as of the sponsor's last update on 26 Apr 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Neuromuscular Recovery Scale (time frame: 8-11 months). 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 26 Apr 2024; AzTrials last refreshed its copy on 30 Oct 2026.