Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04077346 |
| Other study ID # |
19.0844 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 12, 2021 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
April 2024 |
| Source |
University of Louisville |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Like in adults, children with spinal cord injury (SCI) in children suffer from neuromuscular
paralysis which results in the inability to sit, stand, and walk. Current therapeutic
interventions, e.g. leg braces, wheelchairs, largely aim to compensate for paralysis based on
the assumption that damage to the central nervous system is permanent and irreversible.The
discovery of the "intelligent" spinal cord, known as the central pattern generator (CPG), has
demonstrated that complex neuronal networks are capable of generating rhythmic and
coordinated motor patterns and has set forth a major paradigm shift in the investigators
expectation of the possibility for recovery even with severe SCI. Studies have demonstrated,
first, that after SCI, the CPG can be "accessed", reactivated, and retrained via sensory
feedback arising from the muscles and joints during activity-based locomotor training
(AB-LT). Second, application of epidural and transcutaneous stimulation (TcStim) to the
spinal cord below the level of lesion can augment the neuromuscular capacity for voluntary
movement, standing and stepping in adults with chronic motor complete SCI. While neural
mechanisms for stepping regulation have been demonstrated in adults testing single vs.
multi-site stimulation, this inherent capacity must be examined in children with SCI.
Similarly, the addition of stimulation during AB-LT in adults with motor complete SCI has
resulted in remarkable recovery of over ground walking. The immediate and long-term response
of such combined therapeutic exposure and subsequent training has yet to be examined in
children. Children with SCI may not only benefit from these novel therapeutic approaches but
also demonstrate greater improvements in neuromuscular recovery due to inherent plasticity.
The investigators' preliminary work has demonstrated the safety and feasibility of TcStim in
children with SCI. Therefore, the specific aims of this proposal are to 1) investigate the
spinal mechanisms for regulation of locomotor circuitry in children with SCI using TcStim, 2)
assess whether the combination of task-specific AB-LT and TcStim can acutely potentiate lower
limb muscle activity during facilitated stepping, and 3) assess training effects of TcStim
combined with AB-LT to promote stepping capacity in non-ambulatory children with SCI.
For this pilot study 8 participants, ages 4-12 years with chronic, acquired SCI, T10 and
above and non-ambulatory will be recruited.
For Aim 1, n=8, TcStim will be used to stimulate a single or multi site spinal levels to
produce stepping/locomotor activity in lower limbs. Knee, hip, ankle kinematics and
electromyography (EMG) of the lower limb muscles in response to stimulation will be recorded
during the experiments. The investigators will determine the stimulation parameters that
produce rhythmic movements with the greatest increase in lower limb joint excursions as well
as EMG amplitude.
For Aim 2, n=8, TcStim will be delivered while participants attempt to take a step overground
and while stepping on a computerized treadmill with an overhead partial body weight support
(BWS) system. The participants will be stepped at age-appropriate speeds and BWS optimizing
the stepping kinematics. The speed and the amount of body weight support provided during the
assessment as well as full body kinematics and EMG signals from trunk and lower limb muscles
will be recorded during facilitated stepping with and without TcStim.
For Aim 3, n=6, participants will receive 60 sessions of AB-LT+Tcstim. Ability to initiate
and complete a step overground with and without stimulation along with full body kinematics
and electromyographic (EMG) signals from trunk and lower limb muscles will be recorded at
baseline, 20, 40, and 60 sessions of the combined therapy of AB-LT plus TcStim.
