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

NCT05091463 | Enrolling By Invitation FDA Device

• 1 other identifier: 21.0303
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injuries

Keywords

Pediatric-onset; Transcutaneous spinal stimulation; Trunk deficit

Outcome Measures

Primary Outcomes (2)

• Segmental Assessment of Trunk Control

  Participants will be tested in a seated position with arms and back unsupported on a bench with hip and knee both at 90 degrees of flexion and feet supported. Trunk control will be examined with a therapist progressively changing the level of support, starting at the shoulder girdle and axilla to assess cervical (head) control. They will then progress to the inferior-scapula (mid-thoracic), lower-ribs (lower thoracic), below-ribs (upper lumbar), pelvis (lower lumbar) and no support, to measure full trunk control. Pelvis will be placed in a neutral position via manual support for all testing, except for the no support level.

  Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)

• Modified Function Reach (MFR)

  Participants will be in a sitting position with hip, knees, and ankles in 90 degrees flexion, with feet flat on the floor. The initial reach will be measured using a yard stick with participant reaching (leaning) as far as possible (front, right, and left). Distance covered, in centimeters from initial position to furthest reaching at the level of the 3rd metacarpal, will be recorded in all 3 directions.

  Change from baseline (Pre-Intervention), after 20 sessions, after 40 sessions, after 60 sessions and after 3 months post 60 sessions(each session is 1.5 hours)

Secondary Outcomes (2)

• Center of Pressure (CoP) displacement

  baseline (Pre-Intervention), After 60 intervention Sessions (each session is 1.5 hours) and 3 months after 60 sessions end

• Angular Excursions of the Trunk

  baseline (Pre-Intervention), After 60 Intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end

Study Arms (1)

Transcutaneous spinal stimulation

EXPERIMENTAL

Participants with chronic SCI will receive 60 sessions of activity based-locomotor training (AB-LT) combined with transcutaneous stimulation (scTS).

Device: Biostim-5/Neostim transcutaneous spinal stimulator

Interventions

Biostim-5/Neostim transcutaneous spinal stimulator DEVICE

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.

Transcutaneous spinal stimulation

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Chronic (\> 1 year since injury), Acquired Upper motor Neuron injury (T10 and above)
• Discharged from in-patient rehabilitation
• Moderate to severe trunk control deficit as assessed by the Segmental Assessment of Trunk Control (SATCo, score \<16/20) OR unable to fully sit upright while lifting their arms or reaching outside of their base of support while maintaining posture
• Novice to activity-based locomotor training and transcutaneous spinal stimulation

You may not qualify if:

• Botox use within the past 3 months
• Current oral baclofen use and unwillingness or unable to wean under medical guidance
• Baclofen pump use
• Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation
• Prior surgery for scoliosis
• Unwillingness to wean from the use of thoraco-lumbosacral orthosis (TLSO) during study
• Spina Bifida as etiology of spinal cord injury

Sponsors & Collaborators

• University of Louisville: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Kentucky Spinal Cord Injury Res Center, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andrea L Behrman, PT, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 25, 2021
• Study Start: August 31, 2021
• Primary Completion: July 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)