Spinal Cord Injury CervicalNCT06489106
Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
A study testing Activity based upper extremity training with and without stimulation in people with Spinal Cord Injury Cervical, run by University of Louisville at 1 site in United States.
Trial summary
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Activity based upper extremity training with and without stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2025to 31 Jul 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For aim 1 and 2, 10 participants with SCI:
- age 7-12 years;
- chronic (>6 months), acquired upper motor neuron SCI;
- cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
- Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
- For Aim 3, 4 participants with SCI who:
Show all 10Show fewer
- complete aim 1 and 2;
- consent/assent for aim 3
- demonstrate a minimum of 10% increase in HG force with scTS (aim1-2)
- confirmed volitional activation in hand muscles during hang grip assessment without scTS
Who cannot join
- For all 3 aims will include:
- Botox use within past 3 months (for upper or lower extremity);
- current oral baclofen (or pump);
- musculoskeletal impairment limiting range of motion;
- unhealed fracture or other medical condition limiting participation in AB-UET;
- etiology of spina bifida;
- total ventilator dependence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kentucky Spinal Cord Injury Research Center
Louisville, Kentucky, 40202
About this study
Official title: Optimization of Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
The main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.
Read the detailed description
After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, the investigators will recruit and enroll 10 participants. In the first week, participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function. On day 5, eligible participants will have experimental assessments to measure hand grip and control, both with and without spinal cord stimulation (scTS) at one or two neck sites optimized to improve hand grip. On day 6, participants will have similar assessments, this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control.
For the third aim, 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come, first-served basis. They will undergo 20 sessions of activity-based upper extremity training, followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2. After completing the training, participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Activity based upper extremity training with and without stimulation
- Keywords
- Pediatric onset, Transcutaneous spinal cord stimulation, Hand and arm function, Chronic spinal cord injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity based upper extremity training with and without stimulationDevice
Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session. For AB-UET+ stimulation (scTS), UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of ~ 10 minute/bouts.
| Study group | Role | What they receive |
|---|---|---|
| Activity based upper extremity training | Active comparator | Activity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session. Receives: Device: Activity based upper extremity training with and without stimulation |
| Activity based upper extremity training with stimulation | Experimental | Activity-based upper extremity training (AB-UET + scTS) will be administered 5d/week and 1 hour 30 minutes/session. UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of ~ 10 minute/bouts. Receives: Device: Activity based upper extremity training with and without stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip
Voluntary maximal hand grip force
Measured: 12 weeks
Hand control
Peak to peak distance on hand grip force
Measured: 12 weeks
Secondary outcomes (4)
Functional neurophysiological assessment-Upper extremity
Multi-muscle activation patterns
Measured: 12 weeks
Pediatric Neurorecovery scale
Pediatric Neurorecovery scale (NRS) is a validated clinical scale that assesses a child's (age 1-12 years) neuromuscular capacity to perform everyday tasks without behavioral compensation, physical assistance, or assistive device. The total score is the sum of all tasks on a scale from 1-12. For a total of 12 items, the highest score being 144 and lowest a sore of 12. Higher scores indicate improved function.
Measured: 12 weeks
Capabilities of upper extremity test
The Capabilities of the Upper Extremity Test (CUE-T) is a performance measure intended to assess upper extremity function following spinal cord injury. The CUE-T is an objective measure of the ability to complete actions and tasks involving the arm and hand in individuals with tetraplegia and can be used clinically, for research and in clinical trials. Respondents answer questions on a 7-point scale that represents their self-perceived difficulty in performing the action, with 1 indicating "totally limited, can't do at all" and 7 indicating "not at all limited". The total score is the sum of all responses, and ranges from 32 to 224, with higher scores indicating greater function.
Measured: 12 weeks
Box and block test
The Box and Block Test (BBT) measures unilateral gross manual dexterity and is validated in pediatric population. The score is the number of blocks carried from one compartment to the other in one minute. Each hand is scored separately. Higher scores within 1-minute indicate better manual dexterity.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start13 Jun 2025
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Goutam Singh, University of Louisville
- Investigators
- Goutam Singh, PhD, Principal investigator, University of Louisville and Spalding University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489106
- Sponsor's protocol ID
- 24.0267
- Status last verified
- Feb 2026
- First submitted
- 27 Jun 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Noninvasive Spinal Stimulation to Restore Hand Function in Children With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06489106
- Acronym / sponsor ID
- 24.0267
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Pediatric onset, Transcutaneous spinal cord stimulation, Hand and arm function, Chronic spinal cord injury
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Jul 2024 (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 main goal of this pilot study is to find the best ways to use transcutaneous spinal cord stimulation (scTS) to improve hand function in children with spinal cord injuries (SCI). The investigators will start by exploring the best places and strengths for applying scTS on the neck, the added benefits of applying scTS on the lower back (T11-T12), and comparing the effects of using activity based upper extremity training (a control treatment) alone versus combining it with scTS to help children with chronic SCI regain hand function.
Detailed description
After learning about the study and potential risks, parents/legal guardians and their eligible children with SCI will sign consent and assent forms, respectively. For the first two aims of the study, the investigators will recruit and enroll 10 participants. In the first week, participants will undergo clinical assessments from day 1 to day 4 to categorize the severity and level of their injuries and assess their current arm and hand function. On day 5, eligible participants will have experimental assessments to measure hand grip and control, both with and without spinal cord stimulation (scTS) at one or two neck sites optimized to improve hand grip. On day 6, participants will have similar assessments, this time adding stimulation to the trunk area to help with upright sitting and study its impact on hand grip and control.
For the third aim, 4 participants who showed improved hand grip and control with stimulation in aims 1 and 2 will be selected on a first-come, first-served basis. They will undergo 20 sessions of activity-based upper extremity training, followed by 20 more sessions with the optimal stimulation sites identified from aims 1 and 2. After completing the training, participants will be asked to follow up and repeat experimental and clinical assessments to determine how long the improvements last.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity based upper extremity training | Active comparator | Device: Activity based upper extremity training with and without stimulationActivity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session. |
| Activity based upper extremity training with stimulation | Experimental | Device: Activity based upper extremity training with and without stimulationActivity-based upper extremity training (AB-UET + scTS) will be administered 5d/week and 1 hour 30 minutes/session. UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of ~ 10 minute/bouts. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- age 7-12 years;
- chronic (>6 months), acquired upper motor neuron SCI;
- cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors
- Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip
- complete aim 1 and 2;
Key exclusion criteria (7 listed)
- Botox use within past 3 months (for upper or lower extremity);
- current oral baclofen (or pump);
- musculoskeletal impairment limiting range of motion;
- unhealed fracture or other medical condition limiting participation in AB-UET;
- etiology of spina bifida;
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 |
|---|---|---|
| Activity based upper extremity training with and without stimulationActivity-based upper extremity training (AB-UET) will be administered 5d/week and 1 hour 30 minutes/session. For AB-UET+ stimulation (scTS), UE tasks will be repeated with and without scTS so that scTS is administered intermittently for the duration of ~ 10 minute/bouts. | Device | Activity based upper extremity training, Activity based upper extremity training with stimulation |
Primary outcome
Hand grip
Time frame: 12 weeks
Voluntary maximal hand grip force
Hand control
Time frame: 12 weeks
Peak to peak distance on hand grip force
4 secondary outcomes
Functional neurophysiological assessment-Upper extremity
Time frame: 12 weeks
Pediatric Neurorecovery scale
Time frame: 12 weeks
Capabilities of upper extremity test
Time frame: 12 weeks
Box and block test
Time frame: 12 weeks
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 18 Feb 2026.
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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.
Goutam Singh, PhD principal investigator
University of Louisville and Spalding University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity based upper extremity training with and without stimulation in people with Spinal Cord Injury Cervical, 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 10 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: enrolling by invitation, as of the sponsor's last update on 18 Feb 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?
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?
Hand grip (time frame: 12 weeks). 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 18 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.