Spinal Cord InjuriesNCT05091463
Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI
A study testing Biostim-5/Neostim transcutaneous spinal stimulator in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial summary
The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Biostim-5/Neostim transcutaneous spinal stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2021to 3 Oct 2025
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronic (> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
- Discharged from in-patient rehabilitation
- Moderate to severe trunk control deficit as assessed by the Segmental Assessment of Trunk Control (SATCo, score <16/20) OR unable to fully sit upright while lifting their arms or reaching outside of their base of support while maintaining posture
- Novice to activity-based locomotor training and transcutaneous spinal stimulation
Who cannot join
- Botox use within the past 3 months
- Current oral baclofen use and unwillingness or unable to wean under medical guidance
- Baclofen pump use
- Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation
- Prior surgery for scoliosis
- Unwillingness to wean from the use of thoraco-lumbosacral orthosis (TLSO) during study
- Spina Bifida as etiology of spinal cord injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Kentucky Spinal Cord Injury Res Center, University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric Spinal Cord Injury
The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury.
The investigators will recruit 12 participants, ages 3-12 with chronic, acquired SCI, T10 and above and non-ambulatory. The participants in this study will be novices to scTS and AB-LT.
Read the detailed description
This is a within subjects, repeated measures design study. Participants with chronic, acquired SCI (T10 and above and non-ambulatory), ages 3-12 years will serve as their own control and will participate in the studies for all three aims. The participants in this study will be novices to scTS and AB-LT. Medical history and demographics will be collected according to NINDS-Common Data Elements guidelines for pediatric SCI and recommended, standardized outcomes used.
The participants will participate in 60 sessions, 5 days/week for 90 minutes/session. The participants will be assessed at the following time points: Baseline (prior to intervention), after 20 sessions, after 40 sessions and after 60 sessions.
If possible, there will be follow-up assessments occur at 3 months post-60 sessions.
Aim 1: To determine the effects of 60 AB-LT + scTS therapy sessions on sitting posture and trunk control.
Participants will be tested over a total of 4 session (2 pre- and 2 post-60 session intervention). Sessions 1 and 2 will include testing for clinical (Segmental Assessment of Trunk Control (SATCo) and Modified Functional Reach (MFR)) and biomechanical outcomes (Sitting with best posture and MFR), respectively. The two sessions will be conducted within one week.
Aim 2: Determine a) the rate of change in sitting posture and trunk control across, 20, 40, and 60 sessions of AB-LT + scTS, b) the durability of training effects at 3-months follow-up, and c) responsiveness of clinical outcome measures (SATCo and MFR) of trunk control.
Aim 3: To determine residual activation of trunk muscle below the level of the lesion, functional neurophysiological assessment (FNPA) and trunk perturbations will be assess pre- and post-intervention.
The investigators will attain parent/guardian informed consent and participant assent for children > 7 years. Twelve total participants, ages 3-12 years will be recruited and enrolled for all three aims. Participants will be enrolled for 60 sessions (3 months) for the intervention and will be re-tested 3 months post-training.
- Conditions
- Spinal Cord Injuries
- Being tested
- Biostim-5/Neostim transcutaneous spinal stimulator
- Keywords
- Pediatric-onset, Transcutaneous spinal stimulation, Trunk deficit
- 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.
Biostim-5/Neostim transcutaneous spinal stimulatorDevice
Transcutaneous spinal stimulation (scTS): The 5-channel stimulator capable of generating pain-free biphasic rectangular waveform of 0.3 to 1.0 ms pulses with a frequency of 5-10 kHz will be used to stimulate at single or multi-site spinal levels. Transcutaneous stimulation will be delivered in combination with activity based locomotor training in 5-10 minute bouts of stimulation at sub-motor threshold during daily sessions (5x/week) lasting for 90 minutes for a total of 60 sessions of therapy. The sessions will consist of 55-60 minutes on the treadmill for facilitated standing/stepping followed by 30 minutes of activities off the treadmill in sitting, standing, or stepping.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal stimulation | Experimental | Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS). Receives: Device: Biostim-5/Neostim transcutaneous spinal stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Segmental Assessment of Trunk Control
Participants will be tested in a seated position with arms and back unsupported on a bench with hip and knee both at 90 degrees of flexion and feet supported. Trunk control will be examined with a therapist progressively changing the level of support, starting at the shoulder girdle and axilla to assess cervical (head) control. They will then progress to the inferior-scapula (mid-thoracic), lower-ribs (lower thoracic), below-ribs (upper lumbar), pelvis (lower lumbar) and no support, to measure full trunk control. Pelvis will be placed in a neutral position via manual support for all testing, except for the no support level.
Measured: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
Modified Function Reach (MFR)
Participants will be in a sitting position with hip, knees, and ankles in 90 degrees flexion, with feet flat on the floor. The initial reach will be measured using a yard stick with participant reaching (leaning) as far as possible (front, right, and left). Distance covered, in centimeters from initial position to furthest reaching at the level of the 3rd metacarpal, will be recorded in all 3 directions.
Measured: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
Secondary outcomes (2)
Center of Pressure (CoP) displacement
Center of pressure is the location on the supporting surface where the resultant vertical force vector would act if it could be considered to have a single point of application. A shift of CoP is an indirect measure of postural sway and thus a measure of a person's ability to maintain balance.
Measured: baseline (Pre-Intervention), After 60 intervention Sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Angular Excursions of the Trunk
Degrees of flexion/extension, adduction/abduction and rotation, using wireless motion sensors.
Measured: baseline (Pre-Intervention), After 60 Intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start31 Aug 2021
- Primary completion2 Oct 2025
- Study completion3 Oct 2025
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 LouisvilleThe 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Andrea L. Behrman, PhD, PT, University of Louisville
- Investigators
- Andrea L Behrman, PT, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05091463
- Sponsor's protocol ID
- 21.0303
- Status last verified
- Sep 2026
- First submitted
- 13 Aug 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05091463
- Acronym / sponsor ID
- 21.0303
- Conditions
- Spinal Cord Injuries
- Keywords
- Pediatric-onset, Transcutaneous spinal stimulation, Trunk deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 3 Oct 2025 (actual)
- First posted
- 25 Oct 2021 (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.
The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury.
The investigators will recruit 12 participants, ages 3-12 with chronic, acquired SCI, T10 and above and non-ambulatory. The participants in this study will be novices to scTS and AB-LT.
Detailed description
This is a within subjects, repeated measures design study. Participants with chronic, acquired SCI (T10 and above and non-ambulatory), ages 3-12 years will serve as their own control and will participate in the studies for all three aims. The participants in this study will be novices to scTS and AB-LT. Medical history and demographics will be collected according to NINDS-Common Data Elements guidelines for pediatric SCI and recommended, standardized outcomes used.
The participants will participate in 60 sessions, 5 days/week for 90 minutes/session. The participants will be assessed at the following time points: Baseline (prior to intervention), after 20 sessions, after 40 sessions and after 60 sessions.
If possible, there will be follow-up assessments occur at 3 months post-60 sessions.
Aim 1: To determine the effects of 60 AB-LT + scTS therapy sessions on sitting posture and trunk control.
Participants will be tested over a total of 4 session (2 pre- and 2 post-60 session intervention). Sessions 1 and 2 will include testing for clinical (Segmental Assessment of Trunk Control (SATCo) and Modified Functional Reach (MFR)) and biomechanical outcomes (Sitting with best posture and MFR), respectively. The two sessions will be conducted within one week.
Aim 2: Determine a) the rate of change in sitting posture and trunk control across, 20, 40, and 60 sessions of AB-LT + scTS, b) the durability of training effects at 3-months follow-up, and c) responsiveness of clinical outcome measures (SATCo and MFR) of trunk control.
Aim 3: To determine residual activation of trunk muscle below the level of the lesion, functional neurophysiological assessment (FNPA) and trunk perturbations will be assess pre- and post-intervention.
The investigators will attain parent/guardian informed consent and participant assent for children > 7 years. Twelve total participants, ages 3-12 years will be recruited and enrolled for all three aims. Participants will be enrolled for 60 sessions (3 months) for the intervention and will be re-tested 3 months post-training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous spinal stimulation | Experimental | Device: Biostim-5/Neostim transcutaneous spinal stimulatorParticipants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS). |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Chronic (> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
- Discharged from in-patient rehabilitation
- Moderate to severe trunk control deficit as assessed by the Segmental Assessment of Trunk Control (SATCo, score <16/20) OR unable to fully sit upright while lifting their arms or reaching outside of their base of support while maintaining posture
- Novice to activity-based locomotor training and transcutaneous spinal stimulation
Key exclusion criteria (7 listed)
- Botox use within the past 3 months
- Current oral baclofen use and unwillingness or unable to wean under medical guidance
- Baclofen pump use
- Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation
- Prior surgery for scoliosis
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 |
|---|---|---|
| Biostim-5/Neostim transcutaneous spinal stimulatorTranscutaneous spinal stimulation (scTS): The 5-channel stimulator capable of generating pain-free biphasic rectangular waveform of 0.3 to 1.0 ms pulses with a frequency of 5-10 kHz will be used to stimulate at single or multi-site spinal levels. Transcutaneous stimulation will be delivered in combination with activity based locomotor training in 5-10 minute bouts of stimulation at sub-motor threshold during daily sessions (5x/week) lasting for 90 minutes for a total of 60 sessions of therapy. The sessions will consist of 55-60 minutes on the treadmill for facilitated standing/stepping followed by 30 minutes of activities off the treadmill in sitting, standing, or stepping. | Device | Transcutaneous spinal stimulation |
Primary outcome
Segmental Assessment of Trunk Control
Time frame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
Participants will be tested in a seated position with arms and back unsupported on a bench with hip and knee both at 90 degrees of flexion and feet supported. Trunk control will be examined with a therapist progressively changing the level of support, starting at the shoulder girdle and axilla to assess cervical (head) control. They will then progress to the inferior-scapula (mid-thoracic), lower-ribs (lower thoracic), below-ribs (upper lumbar), pelvis (lower lumbar) and no support, to measure full trunk control. Pelvis will be placed in a neutral position via manual support for all testing, except for the no support level.
Modified Function Reach (MFR)
Time frame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)
Participants will be in a sitting position with hip, knees, and ankles in 90 degrees flexion, with feet flat on the floor. The initial reach will be measured using a yard stick with participant reaching (leaning) as far as possible (front, right, and left). Distance covered, in centimeters from initial position to furthest reaching at the level of the 3rd metacarpal, will be recorded in all 3 directions.
2 secondary outcomes
Center of Pressure (CoP) displacement
Time frame: baseline (Pre-Intervention), After 60 intervention Sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Angular Excursions of the Trunk
Time frame: baseline (Pre-Intervention), After 60 Intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
Andrea L Behrman, PT, PhD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biostim-5/Neostim transcutaneous spinal stimulator in people with Spinal Cord Injuries, run by University of Louisville 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 4 inclusion and 7 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 11 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Segmental Assessment of Trunk Control (time frame: Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)). 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 11 Sep 2026.