A pilot study combining noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children with cerebral palsy

Abstract

Cerebral Palsy (CP) is the most common pediatric motor disability with multiple symptoms and etiologies. CP is exhibited through sensorimotor delays, impaired posture resulting in limited activities and participation. Our recently concluded, single arm, unblinded, pilot study (NCT04882592) explored whether an intervention combining non-invasive spinal neuromodulation during an activity-based neurorehabilitation therapy (ABNT) can improve voluntary sensory-motor function captured via the Gross Motor Function Measure (GMFM-88) scores (primary outcome). Sixteen children diagnosed with CP with Gross Motor Function Classification Scale levels I-V were recruited and received the same intervention (2x/week for 8 weeks) to correct the dysfunctional connectivity between supraspinal and spinal networks using the normally developed proprioception. We demonstrate that the intervention was associated with clinically and statistically significant improvement in GMFM-88 scores in all children, thus meeting the prespecified primary endpoint. However, the improvement with ABNT alone needs further exploration. No serious adverse events were observed (safety endpoint).

First Use of Non-Invasive Spinal Cord Stimulation in Motor Rehabilitation of Children with Spinal Muscular Atrophy

“…One or two regions of the spinal cord were stimulated, above the cervical or lumbar enlargement of the spinal cord and/or above the cauda equina of the spinal cord, as previously described [ 6 , 7 , 8 , 9 , 11 , 12 , 15 ]. When exposed to the muscles of the upper extremities, stimulation of the neck and upper thoracic region was used.…”

“…The efficiency and safety of using electrical transcutaneous spinal cord stimulation (tSCS) in motor rehabilitation of the adult and pediatric patients with severe spinal cord injury have been demonstrated [ 6 , 7 , 8 , 9 , 10 ]. Additionally, tSCS is being used in the rehabilitation of children with cerebral palsy [ 11 , 12 ]. In [ 11 ], the experimental group received tSCS at 2 levels, above the T11 and L2 vertebrae, in combination with locomotor training on a treadmill, while the control group received similar training without stimulation.…”

“…This complex shape makes it possible to increase the strength of the current to excite the afferents of the posterior roots of the spinal cord and thereby modulate the motor neurons activity [ 14 ]. The tSCS is well tolerated by healthy subjects with normal sensitivity [ 15 ], by pediatric patients with spinal injury [ 12 ] and with cerebral palsy [ 11 ]. In last two years, it has been revealed that the kilohertz carrier frequency does not affect pain tolerance and the posterior radicular motor evoked responses in adult healthy subjects [ 16 , 17 ].…”

Neuromodulation of the peripheral nervous system: Bioelectronic technology and prospective developments

“…[52] Additionally, neuromodulation can promote neuroplasticity, which further leads to improved motor and cognitive function over time. [53] Overall, neuromodulation of the PNS can offer significant benefits for individuals with CP and can help improve their quality of life.…”

“…As electrical stimulation of the peripheral nerves and muscles can activate paralyzed or weakened muscles, improving their range of motion, strength, and overall functionality, neuromodulation can help individuals with CP not only by reducing the pain associated with muscle spasticity but also by improving motor function, reducing muscle spasticity, and improving bladder and bowel function [52] . Additionally, neuromodulation can promote neuroplasticity, which further leads to improved motor and cognitive function over time [53] . Overall, neuromodulation of the PNS can offer significant benefits for individuals with CP and can help improve their quality of life.…”