Spinal Cord Injury Cervical
Conditions
Keywords
Pediatric onset, Transcutaneous spinal cord stimulation, Hand and arm function, Chronic spinal cord injury
Brief 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). 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.
Interventions
DEVICEActivity based upper extremity training with and without stimulation
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.
Sponsors
University of Louisville
The Craig H. Neilsen Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
For aim 1 and 2, 10 participants with SCI: 1. age 7-12 years; 2. chronic (\>6 months), acquired upper motor neuron SCI; 3. cervical SCI at or above C8 neurological level with motor score of 1-3 for finger flexors 4. Pediatric Neurorecovery scale score of ≥2B and ≤ 4C for impaired grip For Aim 3, 4 participants with SCI who: 1. complete aim 1 and 2; 2. consent/assent for aim 3 3. demonstrate a minimum of 10% increase in HG force with scTS (aim1-2) 4. confirmed volitional activation in hand muscles during hang grip assessment without scTS
Exclusion criteria
For all 3 aims will include: 1. Botox use within past 3 months (for upper or lower extremity); 2. current oral baclofen (or pump); 3. musculoskeletal impairment limiting range of motion; 4. unhealed fracture or other medical condition limiting participation in AB-UET; 5. etiology of spina bifida; 6. total ventilator dependence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip | 12 weeks | Voluntary maximal hand grip force |
| Hand control | 12 weeks | Peak to peak distance on hand grip force |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional neurophysiological assessment-Upper extremity | 12 weeks | Multi-muscle activation patterns |
| Pediatric Neurorecovery scale | 12 weeks | 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. |
| Capabilities of upper extremity test | 12 weeks | 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. |
| Box and block test | 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGoutam Singh, PhD
University of Louisville and Spalding University
Outcome results
None listed