Spinal Cord InjuriesNCT04032990
Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury
A study testing Biostim-5 transcutaneous spinal stimulator in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial summary
Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm… Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Biostim-5 transcutaneous spinal stimulator
- 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
- 14 Nov 2019to Dec 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- history of chronic, acquired SCI, (>1 year since injury);
- SCI involves cervical and/or high thoracic (T1) levels
- moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)
- discharged from in-patient rehabilitation
Who cannot join
- botox use within past 3 months;
- current baclofen use
- unhealed upper extremity fracture
- any other medical complication limiting participation in the assessments and/or activity- based upper extremity training;
- congenital SCI
- 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
Department of Neurosurgery
Louisville, Kentucky, 40202
About this study
Official title: Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury
Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm and hand muscles while practicing grasping, pinching, and reaching movements. The long-term goal is to provide better therapies that will improve the ability of children with SCI to more successfully play and accomplish everyday tasks using their arms and hands, similar to before their injury.
Read the detailed description
Adults with cervical spinal cord injury (SCI) rank gaining arm and hand function as the highest priority for improving their quality of life. Children with SCI, similarly experience paralysis of hand and arm muscles that limits their engagement in play and exploration typical for child development . Furthermore, pediatric-onset SCI disrupts the acquisition of motor skills involved in activities of daily living such as feeding, dressing and grooming increasing the child's dependence on a parent/caregiver. Current interventions teach persons with SCI to use a brace or splint to compensate for paralysis or weakness of hand muscles. Others are invasive requiring nerve or tendon transplantation and/or electrode implantation for functional electrical stimulation. Transcutaneous electrical spinal cord stimulation (TcStim) is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord below the level of injury to generate patterned motor output. In adults with chronic SCI, TcStim acutely (immediately) augments trunk control and improves upper extremity function when combined with task-specific training. In children with cerebral palsy, TcStim in combination with locomotor training improves walking ability. Thus, the long-term objectives are 1) to investigate the therapeutic potential of TcStim for improving arm/hand function and 2) provide high quality scientific evidence to guide the clinical use of neurotherapeutic interventions promoting recovery in children with SCI. As children with SCI represent a vulnerable population, we first must establish the safety and feasibility of any potential novel therapeutic approach. Therefore, the specific aims of this proposal are to 1) determine proof-of-principle, safety and feasibility of TcStim for acute increase of hand/arm function in children with SCI and 2) determine the safety and feasibility of TcStim in combination with activity-based upper extremity training (AB-UET) across 40 sessions in children with SCI. For this pilot study 8-10 participants, ages 5-18 years with chronic, acquired SCI who have completed ≥ 40 sessions of activity-based upper extremity training (AB-UET) with neuromuscular stimulation will be recruited. For Aim 1, TcStim parameters will be optimized for arm/hand function. Arm/hand function will be assessed using the three tasks: overhead reach, forward reach and grasp and in-hand manipulation for no-TcStim and TcStim conditions measuring kinematics, electromyography of arm and hand muscles. For Aim 2 (safety and feasibility), two participants will undergo 40 sessions of AB-UET in combination with TcStim. To assess long-term safety and feasibility, participant compliance and any difficulties (i.e. risks, discomfort) will be documented and risk-likelihood/risk-benefit established. The long-term goal is to provide better therapies that will improve the ability of children with SCI to use their arms and hands with more success to grasp, reach and use their hands for everyday play and daily tasks.
- Conditions
- Spinal Cord Injuries
- Being tested
- Biostim-5 transcutaneous spinal stimulator
- Keywords
- pediatric-onset, transcutaneous spinal stimulation, upper extremity function
- 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 transcutaneous spinal stimulatorDevice
Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal stimulation - Acute and Training | Experimental | Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects. Receives: Device: Biostim-5 transcutaneous spinal stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of skin irritation
Skin color, particularly change in skin color to pink indicating irritation in the location of the stimulating electrode placement will be assessed prior to stimulation experiments and immediately after; incidence of pink- or redness or irritation and time (minutes-days) to dissipation will be recorded.
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Faces Pain Scale-Revised (scale 0-10)
Faces Pain Scale - Revised is a self-report measure of pain intensity developed for children (C.L. Hicks et al. Pain 93 (2001). It will be used to score the sensation of pain on 0 (min - no pain)-to-10 (max - worst pain ever) metric. The scale depicts 6 facial expressions: first - face with a neutral expression corresponds to pain score of 0, next facial expression is scored as 2, etc. The faces scale will be presented to the participant (ages 3-8) prior to the experiment for baseline measurement, during stimulation and following the experiment.
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Visual Analog Scale (0-10)
To assess pain in the participants ages 8 and above, Visual Analog Scale (self-reported measure) will be presented with 0 corresponding to no pain and 10 corresponding to the "worst pain ever"; the scale will be presented at baseline measurement, during stimulation and following the experiment.
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Blood pressure
continuous beat-by-beat blood pressure (mmHg) recordings will be made using Finapres finger cuff system for 5 minutes prior to and 5 minutes immediately following stimulation while the child is sitting; Brachial arm blood pressure will be periodically measured during stimulation (mmHg).
systolic and diastolic blood pressure values will be compared with the established norms for typically developing children (age and height matched);
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Number of requests to stop the stimulation
Number of participants requesting (or number of request per participant within experimental sessions) to stop stimulation due to pain, fatigue or any other reason (documented)
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Angular excursions of upper extremity and hand
degrees of flexion/extension, adduction/abduction in elbow, shoulder, wrist, fingers
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Hand Grip strength
A hand grip strength dynamometer will be used to assess strength (Newton)
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Secondary outcomes (3)
Heart Rate
heart rate (beats per minute) will be continuously monitored and recorded using 3-lead electrocardiogram.
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Compliance rate
Compliance - number of sessions missed and reason, willingness to continue participation.
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Angular excursions of trunk during trunk control assessments
trunk kinematics (degrees of flexion/extension) in cervical, thoracic and lumbar regions;
Measured: within 2 months for Aim 1, within 3 months for Aim 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start14 Nov 2019
- Primary completion18 Dec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- The Jewish Heritage Foundation for Excellence
- 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
- NCT04032990
- Sponsor's protocol ID
- 19.0810
- Status last verified
- May 2026
- First submitted
- 16 Jul 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh G, Keller A, Lucas K, Borders C, Stout D, King M, Parikh P, Stepp N, Ugiliweneza B, D'Amico JM, Gerasimenko Y, Behrman AL. Safety and Feasibility of Cervical and Thoracic Transcutaneous Spinal Cord Stimulation to Improve Hand Motor Function in Children With Chronic Spinal Cord Injury. Neuromodulation. 2024 Jun;27(4):661-671. doi: 10.1016/j.neurom.2023.04.475. Epub 2023 Jun 1.
PubMed 37269282
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
- Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04032990
- Acronym / sponsor ID
- 19.0810
- Conditions
- Spinal Cord Injuries
- Keywords
- pediatric-onset, transcutaneous spinal stimulation, upper extremity function
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- The Jewish Heritage Foundation for Excellence
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- 18 Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Jul 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.
Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test the safety, comfort, and practicality of a new therapy that stimulates the spinal cord to facilitate activation of arm and hand muscles while practicing grasping, pinching, and reaching movements. The long-term goal is to provide better therapies that will improve the ability of children with SCI to more successfully play and accomplish everyday tasks using their arms and hands, similar to before their injury.
Detailed description
Adults with cervical spinal cord injury (SCI) rank gaining arm and hand function as the highest priority for improving their quality of life. Children with SCI, similarly experience paralysis of hand and arm muscles that limits their engagement in play and exploration typical for child development . Furthermore, pediatric-onset SCI disrupts the acquisition of motor skills involved in activities of daily living such as feeding, dressing and grooming increasing the child's dependence on a parent/caregiver. Current interventions teach persons with SCI to use a brace or splint to compensate for paralysis or weakness of hand muscles. Others are invasive requiring nerve or tendon transplantation and/or electrode implantation for functional electrical stimulation. Transcutaneous electrical spinal cord stimulation (TcStim) is a non-invasive painless technique that augments the intrinsic capacity of the spinal cord below the level of injury to generate patterned motor output. In adults with chronic SCI, TcStim acutely (immediately) augments trunk control and improves upper extremity function when combined with task-specific training. In children with cerebral palsy, TcStim in combination with locomotor training improves walking ability. Thus, the long-term objectives are 1) to investigate the therapeutic potential of TcStim for improving arm/hand function and 2) provide high quality scientific evidence to guide the clinical use of neurotherapeutic interventions promoting recovery in children with SCI. As children with SCI represent a vulnerable population, we first must establish the safety and feasibility of any potential novel therapeutic approach. Therefore, the specific aims of this proposal are to 1) determine proof-of-principle, safety and feasibility of TcStim for acute increase of hand/arm function in children with SCI and 2) determine the safety and feasibility of TcStim in combination with activity-based upper extremity training (AB-UET) across 40 sessions in children with SCI. For this pilot study 8-10 participants, ages 5-18 years with chronic, acquired SCI who have completed ≥ 40 sessions of activity-based upper extremity training (AB-UET) with neuromuscular stimulation will be recruited. For Aim 1, TcStim parameters will be optimized for arm/hand function. Arm/hand function will be assessed using the three tasks: overhead reach, forward reach and grasp and in-hand manipulation for no-TcStim and TcStim conditions measuring kinematics, electromyography of arm and hand muscles. For Aim 2 (safety and feasibility), two participants will undergo 40 sessions of AB-UET in combination with TcStim. To assess long-term safety and feasibility, participant compliance and any difficulties (i.e. risks, discomfort) will be documented and risk-likelihood/risk-benefit established. The long-term goal is to provide better therapies that will improve the ability of children with SCI to use their arms and hands with more success to grasp, reach and use their hands for everyday play and daily tasks.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous spinal stimulation - Acute and Training | Experimental | Device: Biostim-5 transcutaneous spinal stimulatorSafety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while upper extremity function is assessed at 3 time points (acute) and/or in combination with activity-based upper extremity training (40 sessions, 1.5 hours/day, 5 days/week); stimulation will be applied intermittently for no more than 10 minutes at a time. Upper extremity training is based on usual care activities to challenge use of the hands and arms, e.g. reaching, grasping, manipulating objects. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- history of chronic, acquired SCI, (>1 year since injury);
- SCI involves cervical and/or high thoracic (T1) levels
- moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)
- discharged from in-patient rehabilitation
Key exclusion criteria (6 listed)
- botox use within past 3 months;
- current baclofen use
- unhealed upper extremity fracture
- any other medical complication limiting participation in the assessments and/or activity- based upper extremity training;
- congenital SCI
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 transcutaneous spinal stimulatorSafety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury | Device | Transcutaneous spinal stimulation - Acute and Training |
Primary outcome
Incidence of skin irritation
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
Skin color, particularly change in skin color to pink indicating irritation in the location of the stimulating electrode placement will be assessed prior to stimulation experiments and immediately after; incidence of pink- or redness or irritation and time (minutes-days) to dissipation will be recorded.
Faces Pain Scale-Revised (scale 0-10)
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
Faces Pain Scale - Revised is a self-report measure of pain intensity developed for children (C.L. Hicks et al. Pain 93 (2001). It will be used to score the sensation of pain on 0 (min - no pain)-to-10 (max - worst pain ever) metric. The scale depicts 6 facial expressions: first - face with a neutral expression corresponds to pain score of 0, next facial expression is scored as 2, etc. The faces scale will be presented to the participant (ages 3-8) prior to the experiment for baseline measurement, during stimulation and following the experiment.
Visual Analog Scale (0-10)
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
To assess pain in the participants ages 8 and above, Visual Analog Scale (self-reported measure) will be presented with 0 corresponding to no pain and 10 corresponding to the "worst pain ever"; the scale will be presented at baseline measurement, during stimulation and following the experiment.
Blood pressure
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
continuous beat-by-beat blood pressure (mmHg) recordings will be made using Finapres finger cuff system for 5 minutes prior to and 5 minutes immediately following stimulation while the child is sitting; Brachial arm blood pressure will be periodically measured during stimulation (mmHg). systolic and diastolic blood pressure values will be compared with the established norms for typically developing children (age and height matched);
Number of requests to stop the stimulation
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
Number of participants requesting (or number of request per participant within experimental sessions) to stop stimulation due to pain, fatigue or any other reason (documented)
Angular excursions of upper extremity and hand
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
degrees of flexion/extension, adduction/abduction in elbow, shoulder, wrist, fingers
Hand Grip strength
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
A hand grip strength dynamometer will be used to assess strength (Newton)
3 secondary outcomes
Heart Rate
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
Compliance rate
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
Angular excursions of trunk during trunk control assessments
Time frame: within 2 months for Aim 1, within 3 months for Aim 2
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 11 Sep 2026.
- Derived from this study: PubMed 37269282Singh G, Keller A, Lucas K, Borders C, Stout D, King M, Parikh P, Stepp N, Ugiliweneza B, D'Amico JM, Gerasimenko Y, Behrman AL. Safety and Feasibility of Cervical and Thoracic Transcutaneous Spinal Cord Stimulation to Improve Hand Motor Function in Children With Chronic Spinal Cord Injury. Neuromodulation. 2024 Jun;27(4):661-671. doi: 10.1016/j.neurom.2023.04.475. Epub 2023 Jun 1.
- 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.
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 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 6 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 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?
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?
Incidence of skin irritation (time frame: within 2 months for Aim 1, within 3 months for Aim 2). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04032990, which also lists 1 linked publication.
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.