What this study is
Spinal cord injury (SCI) results in damage to the descending neural pathways and leads to the immediate dysfunction of multiple physiological systems below the level of injury. Like adults, children with SCI suffer from neuromuscular paralysis which results in the inability to sit, stand, and walk. Current therapeutic interventions largely aim to compensate for paralysis to achieve mobility based on the assumption that damage to the central nervous system is permanent and irreversible, e.g. use of braces, standers, and wheelchairs. The objective of this proposal is to investigate the use of transcutaneous spinal stimulation (TcStim) to enable stepping in children with chronic SCI.
The investigators will recruit 8 participants, ages 4-12 years with chronic, acquired SCI, T10 and above and non-ambulatory. The aims of this proposal are to 1) investigate the mechanisms of locomotor-specific regulation in the spinal neural circuitry of children with acquired SCI using single vs. multi-site TcStim, 2) investigate the capacity of the lumbosacral spinal cord for integration of task-specific input (e.g. load, speed) during facilitated stepping with and without TcStim, and 3) investigate the training effects of TcStim on the ability to step. Outcomes will provide a necessary initial step in the translation of scientific findings for neuromodulation from adults with SCI to children.
What's being tested
- Biostim-5 transcutaneous spinal stimulator
Intervention · DEVICE
Transcutaneous spinal stimulation (TcStim): The 5-channel stimulator capable of generating (41) 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. TcStim will be delivered in combination with activity based locomotor training in 5 - 10 minute of stimulation at sub-motor threshold daily (5x/week) for 60 sessions
- Transcutaneous Spinal Stimulator + Activity Based Locomotor Training
Intervention · OTHER
Participants will receive a combination of Activity-based locomotor training (AB-LT)+TcStim daily (5x/week) for 60 sessions and will consist of a minimum of 55-60 min on the TM for facilitated standing/stepping followed by 30 min of activities off TM in sitting, standing, or stepping.
Study details
- Sponsor
- University of Louisville
- Conditions
- Spinal Cord Injuries
- Enrolling
- 8 people
- Starts
- 2021-04-12
- Est. completion
- 2026-11
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 4 Years – 12 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Children with acquired, upper motor neuron (T10 and above) SCI, traumatic and non-traumatic,
- Chronic injury, defined as greater than one year post injury
- Age 4-12 years,
- Discharged from inpatient rehabilitation,
- Unable to stand, walk, or initiate steps.
You can't join if
- Botox use within past 3 months
- Current oral baclofen use,
- Baclofen pump in use,
- Musculoskeletal impairment limiting range of motion, unhealed fracture or other medical complication limiting participation,
- Prior surgery for scoliosis, post SCI
- Congenital SCI,
- Total ventilator dependence.
- For Aim 3, additional exclusionary criteria are:; Unwilling or unable to wean from baclofen during training,; Use of braces (trunk or lower limb brace).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDepartment of Neurosurgery, University of Louisville
Louisville, Kentucky, United States
Study team
Sponsor
University of Louisville
Study ID 19.0844
Principal investigator
Andrea L Behrman, PT, PhD
University of Louisville
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.