NCT05091463

Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric SCI

Non-invasive Spinal Stimulation as an Adjuvant Therapy for Trunk Control After Pediatric Spinal Cord Injury

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The overall purpose of this study is to test the efficacy of multi-modal training combining activity-based locomotor training and transcutaneous spinal stimulation (ABLT+scTS) to improve sitting posture and trunk control in children with a chronic spinal cord injury. The investigators will recruit 12 participants, ages 3-12 with chronic, acquired SCI, T10 and above and non-ambulatory. The participants in this study will be novices to scTS and AB-LT.

Detailed description

This is a within subjects, repeated measures design study. Participants with chronic, acquired SCI (T10 and above and non-ambulatory), ages 3-12 years will serve as their own control and will participate in the studies for all three aims. The participants in this study will be novices to scTS and AB-LT. Medical history and demographics will be collected according to NINDS-Common Data Elements guidelines for pediatric SCI and recommended, standardized outcomes used. The participants will participate in 60 sessions, 5 days/week for 90 minutes/session. The participants will be assessed at the following time points: Baseline (prior to intervention), after 20 sessions, after 40 sessions and after 60 sessions. If possible, there will be follow-up assessments occur at 3 months post-60 sessions. Aim 1: To determine the effects of 60 AB-LT + scTS therapy sessions on sitting posture and trunk control. Participants will be tested over a total of 4 session (2 pre- and 2 post-60 session intervention). Sessions 1 and 2 will include testing for clinical (Segmental Assessment of Trunk Control (SATCo) and Modified Functional Reach (MFR)) and biomechanical outcomes (Sitting with best posture and MFR), respectively. The two sessions will be conducted within one week. Aim 2: Determine a) the rate of change in sitting posture and trunk control across, 20, 40, and 60 sessions of AB-LT + scTS, b) the durability of training effects at 3-months follow-up, and c) responsiveness of clinical outcome measures (SATCo and MFR) of trunk control. Aim 3: To determine residual activation of trunk muscle below the level of the lesion, functional neurophysiological assessment (FNPA) and trunk perturbations will be assess pre- and post-intervention. The investigators will attain parent/guardian informed consent and participant assent for children \> 7 years. Twelve total participants, ages 3-12 years will be recruited and enrolled for all three aims. Participants will be enrolled for 60 sessions (3 months) for the intervention and will be re-tested 3 months post-training.

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Biostim-5/Neostim transcutaneous spinal stimulator	Transcutaneous spinal stimulation (scTS): The 5-channel stimulator capable of generating 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. Transcutaneous stimulation will be delivered in combination with activity based locomotor training in 5-10 minute bouts of stimulation at sub-motor threshold during daily sessions (5x/week) lasting for 90 minutes for a total of 60 sessions of therapy. The sessions will consist of 55-60 minutes on the treadmill for facilitated standing/stepping followed by 30 minutes of activities off the treadmill in sitting, standing, or stepping.

Timeline

• Start date: 2021-08-31
• Primary completion: 2025-07-30
• Completion: 2026-07-30
• First posted: 2021-10-25
• Last updated: 2024-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study