Transcutaneous Spinal StimulationNCT03240601
Spinal Cord Stimulation to Augment Activity Based Therapy
A study testing Transcutaneous spinal stimulation in people with Transcutaneous Spinal Stimulation and Walking, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Transcutaneous Spinal Stimulation, Walking, Spasticity
- What is being tested?
- Transcutaneous spinal stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 11 Sep 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to consent and/or authorize use of protected health information
- Be between 18-65 years of age
- Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
- Be eligible for locomotor training at the Shepherd Center
- Be able to take a step, with or without an assistive device
- Have a spinal cord injury, completed in-patient rehabilitation, and have been discharged to home
- Have at least mild "spasticity" affecting leg muscles
- You may participate if you use prescription medications, including baclofen for control of spasticity
Who cannot join
- Inability or unwillingness to consent and/or authorization for use of protected health information
- Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Neurologic level at or below spinal level T12
- History of cardiovascular irregularities
- Problems with following instructions
- Orthopedic problems that would limit your participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
Show all 9Show fewer
- Women who are pregnant, or who have reason to believe they are or may become pregnant due to unknown risks to the fetus associated with tcSCS
- Persons who have implanted stimulators/electronic devices of any type will be excluded due to unknown potential of tcSCS effects
- Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes After Spinal Cord Injury
Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat spasticity, but they often have side effects, like muscle weakness, which can add to movement problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary muscle activity, and rehabilitation can also improve daily function and quality of life. These benefits may be greater when several rehabilitation therapies are used together.
Walking ability can be improved with a type of therapy called "locomotor training". This type of therapy may also have the benefit of decreasing spasticity. When locomotor training (LT) is combined with electrical stimulation, the benefits of training may be increased. In this study, investigators will use a kind of stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate participants' spinal cord nerves during locomotor training.
Read the detailed description
Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasms, clonus, or the stiffness associated with hypertonia. While medications are typically used to treat the general symptoms of spasticity, they often have additional side effects, like muscle weakness, that can impede rehabilitation. Physical therapeutics offer an alternative to these drug treatments, but the most effective therapeutic strategy for managing spasticity has not yet been identified. A combination of physical therapeutics may provide the best strategy for managing spasticity while also improving general motor control for functional movements.
Walking ability can be improved through locomotor training, which has also been shown to reduce spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. To investigate the potential benefits of this combinatorial treatment strategy, investigators will use a kind of electrical stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate spinal cord nerves during locomotor training.
In order to facilitate the translation of study findings into clinical practice, this study uses a pragmatic design, meaning that the study will involve the use of real world clinical settings and practices. Participants will undergo their standard physical therapist directed locomotor training program while receiving transcutaneous spinal cord stimulation (TSS) as an additional treatment. The effects of locomotor training alone will be compared to the combination of locomotor training with TSS, specifically comparing the effects of these treatments on spasticity and walking function.
Investigators expect that the combination of TSS with locomotor training will provide 1) a greater reduction in spasticity and 2) a greater improvement of walking function compared to locomotor training alone.
The findings from this study have the potential to rapidly facilitate the translation of a novel combination treatment for the management of spasticity and improvement of walking function into real world clinical practice.
- Being tested
- Transcutaneous spinal stimulation
- Medical subject headings
- Muscle Spasticity, Spinal Cord 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 TSS
For TSS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Subthreshold | Sham comparator | Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training. Receives: Device: Transcutaneous spinal stimulation |
| Active | Experimental | Individuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training. Receives: Device: Transcutaneous spinal stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Function - 10m Walk Walking Speed (m/s)
You will walk over a mat that contains sensors to measure your walking speed as well as wear motion tracking sensors. You will be allowed to use whatever assistive devices you typically use (e.g., braces, walker, forearm crutches). In addition to walking speed, we will also assess your gait kinematics.
Measured: Change in 10m Walk Speed (m/s) during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Pendulum Test
This test measures the amount of spasticity in your leg muscles. You will sit at the edge of a mat with your lower legs hanging over the edge of the mat. Motion capture sensors (Xsens) will be placed on both of your legs to record changes in your knee joint angles when your leg is dropped. The examiner will straighten your leg and then allow it to drop and swing over the edge of the mat. The angle of your knee and the movement of your leg will be recorded as it drops. This will be performed three times for each leg separately.
Measured: Pendulum angle (degrees) change during the Intervention Phase (Week 2 test to Week 4 test)
Secondary outcomes (5)
Change in Walking Function - 2 Minute Walk
You will walk for 2 minutes overground and we will measure how far you walk.
Measured: 2 Minute Walk test (distance) change during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Ankle Clonus Drop Test
This test measures the amount of spasticity in your ankle. We will use the motion capture sensors to record your ankle joint angles. For this test you will sit upright. Your leg will be raised to 10cm above the rest position and released allowing the front of your foot to land on the edge of a box. The angle bouncing movement of your foot (clonus) will be recorded as it drops and catches on the box. This will be performed three times for each leg separately. Full details of test methods can be found at: Manella, Roach, and Field-Fote. Temporal Indices of Ankle Clonus and Relationship to Electrophysiologic and Clinical Measures in Persons With Spinal Cord Injury. J Neurol Phys Ther. 2017 Oct;41(4):229-238.
Measured: Change in number of clonic ankle oscillations elicited via Ankle Clonus Drop Test during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Muscle Co-contraction During Voluntary Activation
Muscle activity will be recorded using electromyography (EMG) during activities where you move your legs, and activities where your legs are moved by the examiner. Electrodes will be placed on four muscles of your legs (front and back of your thigh and lower leg), you will be asked to move your ankles and extend your legs while we record your muscle activity. We will test whether the EMG is activated in only one muscle (isolated) when you try to activate that muscle, or whether muscles that you are not trying to activate are also activated at the same time (co-contraction)
Measured: Co-contraction change during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Test
A trained therapist will perform the SCATS assessment before and after each training session. SCATS assesses 3 aspects of spasticity: clonus, flexor spasms, extensor spasms in response to perturbation. Scores range from 0-3 as follows: 0 = no reaction; 1 = mild, <3 sec response; 2 = moderate, 3-10 sec response; 3 = severe, >10 sec response
Measured: SCATS scores change during the Intervention Phase (Week 2 test to Week 4 test)
Stimulation Tolerability
Using a 0-10 numerical rating scale (NRS) for pain, you will be asked your perception of pain during the final 2 weeks of stimulation. NRS anchors are 0 = no pain, 10 = pain as bad as you can imagine
Measured: Numerical rating scale of painfulness of stimulation in stimulation group only during stimulation weeks only (weeks 3 and 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Jul 2017
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
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 Transcutaneous Spinal StimulationStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life
- Responsible party
- Sponsor
- Investigators
- Edelle C Field-Fote, PT, PhD, Principal investigator, Shepherd Center, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240601
- Sponsor's protocol ID
- 696
- Status last verified
- Dec 2021
- First submitted
- 17 Jul 2017
- Last updated
- 25 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Influence of Transcutaneous Spinal Cord Stimulation and Locomotor Training on Spasticity and Walking Outcomes After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03240601
- Acronym / sponsor ID
- 696
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Foundation Wings For Life
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Posted 25 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Involuntary muscle activity, often called spasticity, is a common problem following spinal cord injury (SCI) that can make it hard to move. Many things can cause spasticity including: muscle stretch, movement, or it can happen for no reason, and it is often described as an uncontrolled muscle spasm or feeling of stiffness. Drugs are typically used to treat spasticity, but they often have side effects, like muscle weakness, which can add to movement problems. Rehabilitation therapies offer alternatives to drugs for treating involuntary muscle activity, and rehabilitation can also improve daily function and quality of life. These benefits may be greater when several rehabilitation therapies are used together.
Walking ability can be improved with a type of therapy called "locomotor training". This type of therapy may also have the benefit of decreasing spasticity. When locomotor training (LT) is combined with electrical stimulation, the benefits of training may be increased. In this study, investigators will use a kind of stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate participants' spinal cord nerves during locomotor training.
Detailed description
Involuntary muscle activity, often referred to as spasticity, is a common problem following spinal cord injury. Spasticity can be evoked by stimuli or occur spontaneously, and it can manifest as spasms, clonus, or the stiffness associated with hypertonia. While medications are typically used to treat the general symptoms of spasticity, they often have additional side effects, like muscle weakness, that can impede rehabilitation. Physical therapeutics offer an alternative to these drug treatments, but the most effective therapeutic strategy for managing spasticity has not yet been identified. A combination of physical therapeutics may provide the best strategy for managing spasticity while also improving general motor control for functional movements.
Walking ability can be improved through locomotor training, which has also been shown to reduce spasticity. When locomotor training is combined with electrical stimulation, the benefits of training may be increased. To investigate the potential benefits of this combinatorial treatment strategy, investigators will use a kind of electrical stimulation called transcutaneous spinal cord stimulation ("TSS") to stimulate spinal cord nerves during locomotor training.
In order to facilitate the translation of study findings into clinical practice, this study uses a pragmatic design, meaning that the study will involve the use of real world clinical settings and practices. Participants will undergo their standard physical therapist directed locomotor training program while receiving transcutaneous spinal cord stimulation (TSS) as an additional treatment. The effects of locomotor training alone will be compared to the combination of locomotor training with TSS, specifically comparing the effects of these treatments on spasticity and walking function.
Investigators expect that the combination of TSS with locomotor training will provide 1) a greater reduction in spasticity and 2) a greater improvement of walking function compared to locomotor training alone.
The findings from this study have the potential to rapidly facilitate the translation of a novel combination treatment for the management of spasticity and improvement of walking function into real world clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subthreshold | Sham comparator | Device: Transcutaneous spinal stimulationIndividuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will briefly ramp up to the lowest intensity that is first detected by the participant and then ramped down to a level no longer detected by the participant. Participants will continue their locomotor training. |
| Active | Experimental | Device: Transcutaneous spinal stimulationIndividuals will undergo their standard physical therapist directed locomotor training while receiving transcutaneous spinal cord stimulation. The stimulation intensity will ramp up slowly to a level that produces parasthesia (tingling) throughout the lower extremity. This intensity will be applied for 30 minutes while participants continue their locomotor training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability and willingness to consent and/or authorize use of protected health information
- Be between 18-65 years of age
- Be enrolled in Spinal Cord Injury In-Patient or Day Program at the Shepherd Center
- Be eligible for locomotor training at the Shepherd Center
- Be able to take a step, with or without an assistive device
Key exclusion criteria (9 listed)
- Inability or unwillingness to consent and/or authorization for use of protected health information
- Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Neurologic level at or below spinal level T12
- History of cardiovascular irregularities
- Problems with following instructions
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: TSSFor TSS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz. | Device | Active, Subthreshold |
Primary outcome
Change in Walking Function - 10m Walk Walking Speed (m/s)
Time frame: Change in 10m Walk Speed (m/s) during the Intervention Phase (Week 2 test to Week 4 test)
You will walk over a mat that contains sensors to measure your walking speed as well as wear motion tracking sensors. You will be allowed to use whatever assistive devices you typically use (e.g., braces, walker, forearm crutches). In addition to walking speed, we will also assess your gait kinematics.
Change in Spasticity - Pendulum Test
Time frame: Pendulum angle (degrees) change during the Intervention Phase (Week 2 test to Week 4 test)
This test measures the amount of spasticity in your leg muscles. You will sit at the edge of a mat with your lower legs hanging over the edge of the mat. Motion capture sensors (Xsens) will be placed on both of your legs to record changes in your knee joint angles when your leg is dropped. The examiner will straighten your leg and then allow it to drop and swing over the edge of the mat. The angle of your knee and the movement of your leg will be recorded as it drops. This will be performed three times for each leg separately.
5 secondary outcomes
Change in Walking Function - 2 Minute Walk
Time frame: 2 Minute Walk test (distance) change during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Ankle Clonus Drop Test
Time frame: Change in number of clonic ankle oscillations elicited via Ankle Clonus Drop Test during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Muscle Co-contraction During Voluntary Activation
Time frame: Co-contraction change during the Intervention Phase (Week 2 test to Week 4 test)
Change in Spasticity - Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) Test
Time frame: SCATS scores change during the Intervention Phase (Week 2 test to Week 4 test)
Stimulation Tolerability
Time frame: Numerical rating scale of painfulness of stimulation in stimulation group only during stimulation weeks only (weeks 3 and 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Transcutaneous Spinal Stimulation
Not yet recruiting
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Not yet recruiting
Transcutaneous Spinal Cord Stimulation for Neurorehabilitation After Spinal Cord Injury
Spinal Cord Injury
Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Not yet recruiting
Transcutaneous Spinal Cord Stimulation for Blood Pressure Augmentation Immediately After Spinal Cord Injury
Spinal Cord Injury Cervical, Spinal Cord Injuries (SCI)
Recruiting
Locomotor Function Following Transcutaneous Electrical Spinal Cord Stimulation in Individuals With Hemiplegic Stroke
Stroke
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.
Edelle C Field-Fote, PT, PhD principal investigator
Shepherd Center, Inc
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 in people with Transcutaneous Spinal Stimulation and Walking, run by Shepherd Center, Atlanta GA 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 8 inclusion and 9 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 25 Jan 2022. 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. Some participants in this study may receive a placebo. 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 25 Jan 2022). 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 Walking Function - 10m Walk Walking Speed (m/s) (time frame: Change in 10m Walk Speed (m/s) during the Intervention Phase (Week 2 test to Week 4 test)). The study lists 2 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 25 Jan 2022.