Clinical trial NCT04032990: Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury
Official title: Transcutaneous Spinal Stimulation Promoting Recovery of Hand and Arm Function After Pediatric-onset Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: pediatric-onset
transcutaneous spinal stimulation
upper extremity function
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: The Jewish Heritage Foundation for Excellence
First posted: 2019-07-25
Enrollment: 10
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of skin irritation
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Faces Pain Scale-Revised (scale 0-10)
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Visual Analog Scale (0-10)
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Blood pressure
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Number of requests to stop the stimulation
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Angular excursions of upper extremity and hand
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Hand Grip strength
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
Secondary outcomes:
measure: Heart Rate
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Compliance rate
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
measure: Angular excursions of trunk during trunk control assessments
timeFrame: within 2 months for Aim 1, within 3 months for Aim 2
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Department of Neurosurgery
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Andrea L Behrman, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: