Incomplete Spinal Cord InjuryNCT05429736
Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
A study testing Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS) in people with Incomplete Spinal Cord Injury and Spasticity, Muscle, run by Shepherd Center, Atlanta GA at 1 site in United States.
Trial summary
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Incomplete Spinal Cord Injury, Spasticity, Muscle
- What is being tested?
- Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18-70 years of age
- Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
- Have ISNCSCI severity classification C or D
- Able to stand for at least 5 minutes (with or without the aid of an assistive device)
- Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
- Able to rise from sit to stand with moderate assistance from one person
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- Use of prescription medication(s) for control of spasticity if the dosage has not changed in the last 2 weeks and you notify the study staff if your medication(s) change during study participation
- Ability and willingness to consent and authorize use of personal health information
- Ability to follow multiple instructions and communicate pain or discomfort
Who cannot join
- Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Injuries below the neurological spinal level of T12
- Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
- History of cardiovascular irregularities
- Presence of orthopedic conditions that would adversely affect participation in exercise
- Implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g., baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
Show all 9Show fewer
- Any cuts or sensitivity of the skin near the level of stimulation
- Active cancer or history of cancer
- Inability and unwillingness to consent and authorize use of personal health information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.
Read the detailed description
Individuals with SCI will be asked to participate in this study over a four-week period. During the first 2 weeks (wash-in phase), individuals will participate in 6 aerobic and exercise training sessions as part of either an existing outpatient clinical program or by completing a personalized exercise plan. During the intervention phase (last 2 weeks), participants will be randomized to complete 6 training sessions of: 1) motor skill training combined with TSS (MST+TSS group) or 2) motor skill training combined with shamTSS (MST+shamTSS). All participants will complete 3 testing sessions: baseline testing 1 (prior the wash-in phase), testing 2 (after the completion of the wash-in phase and prior the intervention phase), and testing 3 (after the completion of the intervention phase) to assess their walking ability, balance, strength, and spasticity. During the intervention phase and to monitor within-session changes, participants will also complete a short version of walking function and balance assessments prior to and after each training session.
- Conditions
- Incomplete Spinal Cord Injury, Spasticity, Muscle
- Being tested
- Motor Skill Training (MST), Transcutaneous Spinal Stimulation (TSS)
- Keywords
- spinal, cord, incomplete, motor, skill, training, transcutaneous, stimulation, TSS, tSCS, electrophysiology
- Medical subject headings
- Muscle Spasticity, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Skill Training (MST)Behavioural
During MST participants will perform a series of 6 motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Five of these activities will be performed while standing to promote upright control and one activity will be performed while seated (alternating toe-tapping) to provide opportunity for active recovery. Participants will perform each exercise for one minute each, until 4 cycles of the circuit have been completed (approximately 45 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). During MST, participants will wear a chest-worn heart rate monitor to ensure that the optimal HRR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcutaneous Spinal Stimulation (TSS)Device
Also called tSCS
TSS will be delivered using a commercially available neuromuscular electrical stimulator. The active electrode will be positioned directly over the spine at the T11/T12 spinous interspace, and the reference electrode will be positioned over the umbilicus. Stimulation intensity will be gradually increased until paresthesia of the lower legs and feet is achieved or to the highest level each participant can tolerate. Stimulation will be delivered for a total duration of 30 min after paresthesia/ maximum tolerability is reached.
| Study group | Role | What they receive |
|---|---|---|
| MST + TSS | Experimental | Individuals will participate in 6 training sessions of MST combined with TSS. Receives: Behavioral: Motor Skill Training (MST); Device: Transcutaneous Spinal Stimulation (TSS) |
| MST + ShamTSS | Sham comparator | Individuals will participate in 6 training sessions of MST while receiving shamTSS. Receives: Behavioral: Motor Skill Training (MST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 Meter Walk Test
Walking speed (as determined by the 10MWT) is the primary outcome measure for assessing walking function. Participants will complete 3 10MWT trials at each testing session, separated by 2 minutes of seated rest. The average walking speed of the 3 walks will be calculated and used in the analyses.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Secondary outcomes (11)
Change of Spatiotemporal Gait Characteristic (Cadence)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average cadence across three walks will be used in the analysis.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average stride length across three walks will be used in the analysis.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Gait quality will be assessed from spatiotemporal gait characteristics (cadence [strides/min], stride length [cm] of the weaker and stronger limbs, and step length symmetry) collected via instrumented walkway as participants completed three, 10MWT trials at each testing session. The average step length for each leg across three walks will be used to compute the symmetry index (%).
Measured: Testing 1(Day 1), Testing 2 (Day 12), Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Berg Balance Scale
Balance will be measured using the BBS. The BBS total score will be calculated for each participant at each testing session. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. A subset of the BBS will be assess before and after each training session.
Measured: Testing 1 (Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Falls Efficacy Scale-International Version (FES-I)
The FES-I total score will be calculated for each participant at each testing session to measure fear of falling. The total range of scores for the FES-I equals 16-64, with lower scores indicating decreased fear of falling.
Measured: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Spinal Cord Assessment Tool for Spastic Reflexes
The SCATS will be used to assess spasticity. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater spasticity severity.
Measured: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Modified 5-Times Sit-to-Stand
The modified 5-times sit-to-stand test will be used as a measure of functional lower extremity strength. The average time to complete the test will be calculated at each testing session.
Measured: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of 2 Minute Walk Test
Functional walking capacity will be measured based on the 2MWT distance. Total distance walked in 2-minutes will be recorded for each participant at each testing session.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Maximal Isometric Strength
Knee extensor (quadriceps) and ankle plantar flexors (gastrocnemius and soleus) strength will be measured using an isokinetic dynamometer. Maximum knee extensor force will be analyzed based on the maximum force produced over three attempts.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Torque vs Speed Production
Torque vs speed production will be using an isokinetic dynamometer. Maximum rate of torque production will be calculated based on the highest rate measured over three attempts.
Measured: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET)
The modified SCI-SET is a subjective measure used to assess the effects of spasticity on daily life in people with SCI. It requires participants to recall their past 7 days when rating the impact of spasticity. The scale uses a range of -2 (very problematic) to +1 (helpful).
Measured: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Mar 2022
- Primary completionSep 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete Spinal Cord InjuryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Edelle Field-Fote, PT, PhD, Shepherd Center, Atlanta GA
- Investigators
- Edelle Field-Fote, PT, PhD, Principal investigator, Shepherd Center, Atlanta GA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429736
- Sponsor's protocol ID
- 1842303
- Status last verified
- Aug 2026
- First submitted
- 2 May 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- 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 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCIMS Site Specific Project: Activating Spinal Circuits to Improve Walking, Balance, Strength, and Reduce Spasticity
- ClinicalTrials.gov ID
- NCT05429736
- Acronym / sponsor ID
- 1842303
- Conditions
- Incomplete Spinal Cord Injury, Spasticity, Muscle
- Keywords
- spinal, cord, incomplete, motor, skill, training, transcutaneous, stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 23 Jun 2022 (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.
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive spinal stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training (MST) with transcutaneous spinal stimulation (TSS) may further enhance the restoration of function in persons with SCI. Therefore, the purpose of this study is to determine if moderate-intensity, MST can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive TSS will result in greater improvements in function compared to training alone.
Detailed description
Individuals with SCI will be asked to participate in this study over a four-week period. During the first 2 weeks (wash-in phase), individuals will participate in 6 aerobic and exercise training sessions as part of either an existing outpatient clinical program or by completing a personalized exercise plan. During the intervention phase (last 2 weeks), participants will be randomized to complete 6 training sessions of: 1) motor skill training combined with TSS (MST+TSS group) or 2) motor skill training combined with shamTSS (MST+shamTSS). All participants will complete 3 testing sessions: baseline testing 1 (prior the wash-in phase), testing 2 (after the completion of the wash-in phase and prior the intervention phase), and testing 3 (after the completion of the intervention phase) to assess their walking ability, balance, strength, and spasticity. During the intervention phase and to monitor within-session changes, participants will also complete a short version of walking function and balance assessments prior to and after each training session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MST + TSS | Experimental | Behavioral: Motor Skill Training (MST), Device: Transcutaneous Spinal Stimulation (TSS)Individuals will participate in 6 training sessions of MST combined with TSS. |
| MST + ShamTSS | Sham comparator | Behavioral: Motor Skill Training (MST)Individuals will participate in 6 training sessions of MST while receiving shamTSS. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be 18-70 years of age
- Have a spinal cord injury (neurological level C3-T12) that occurred ≥3 months (sub-acute to chronic) prior to enrollment
- Have ISNCSCI severity classification C or D
- Able to stand for at least 5 minutes (with or without the aid of an assistive device)
- Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)
Key exclusion criteria (9 listed)
- Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- Injuries below the neurological spinal level of T12
- Pregnant, or if you have reason to believe you are or may become pregnant due to unknown risks to the fetus associated with TSS
- History of cardiovascular irregularities
- Presence of orthopedic conditions that would adversely affect participation in exercise
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 |
|---|---|---|
| Motor Skill Training (MST)During MST participants will perform a series of 6 motor skill exercises designed to challenge balance, lower extremity coordination, agility, and speed. Five of these activities will be performed while standing to promote upright control and one activity will be performed while seated (alternating toe-tapping) to provide opportunity for active recovery. Participants will perform each exercise for one minute each, until 4 cycles of the circuit have been completed (approximately 45 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). During MST, participants will wear a chest-worn heart rate monitor to ensure that the optimal HRR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test. | Behavioural | MST + ShamTSS, MST + TSS |
| Transcutaneous Spinal Stimulation (TSS)Also: tSCSTSS will be delivered using a commercially available neuromuscular electrical stimulator. The active electrode will be positioned directly over the spine at the T11/T12 spinous interspace, and the reference electrode will be positioned over the umbilicus. Stimulation intensity will be gradually increased until paresthesia of the lower legs and feet is achieved or to the highest level each participant can tolerate. Stimulation will be delivered for a total duration of 30 min after paresthesia/ maximum tolerability is reached. | Device | MST + TSS |
Primary outcome
Change in 10 Meter Walk Test
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Walking speed (as determined by the 10MWT) is the primary outcome measure for assessing walking function. Participants will complete 3 10MWT trials at each testing session, separated by 2 minutes of seated rest. The average walking speed of the 3 walks will be calculated and used in the analyses.
11 secondary outcomes
Change of Spatiotemporal Gait Characteristic (Cadence)
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Spatiotemporal Gait Characteristic (Stride Length - Both Lower Extremities)
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Berg Balance Scale
Time frame: Testing 1 (Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)
Change of Falls Efficacy Scale-International Version (FES-I)
Time frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Spinal Cord Assessment Tool for Spastic Reflexes
Time frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Modified 5-Times Sit-to-Stand
Time frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of 2 Minute Walk Test
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Maximal Isometric Strength
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Torque vs Speed Production
Time frame: Testing 1(Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Change of Modified Spinal Cord Injury Spasticity Evaluation Tool (modified SCI-SET)
Time frame: Testing 1 (Day 1), Testing 2 (Day 12), Testing 3 (Day 27)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Edelle Field-Fote, PT, PhD principal investigator
Shepherd Center, Atlanta GA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS) in people with Incomplete Spinal Cord Injury and Spasticity, Muscle, 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 9 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: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 10 Meter Walk Test (time frame: Testing 1(Day 1), Testing 2 (Day 12), Pre/Post Training 1-6 (Days 15, 17, 19, 22, 24, 26), Testing 3 (Day 27)). 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 1 Sep 2026.