Transcutaneous Spinal Stimulation: Safety and Feasibility for Trunk Control in Children With Spinal Cord Injury

NCT03975634 | Active Not Recruiting FDA Device

• 1 other identifier: 19.0377
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Paralysis of trunk muscles and the inability to sit upright is one of the major problems facing adults and children with spinal cord injury (SCI). Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all children. Transcutaneous spinal stimulation' (TcStim), a stimulation applied over the skin to the sensory nerves and spinal cord, is a promising tool that may further enhance improvements to trunk control. The purpose of this study is to determine the feasibility (can we do it) and safety of Transcutaneous Stimulation (TcStim) in children with SCI to acutely improve sitting upright and when used with activity-based locomotor training (AB-LT). Thus, can we provide this therapy to children and do so safely examining a child's immediate response and cumulative response relative to safety and comfort. Eight participants in this study will sit as best they can with and without the stimulation (i.e. stimulation applied across the skin to the nerves entering the spinal cord and to the spinal cord) and their immediate response (safety, comfort, trunk position) recorded. Then, two participants will receive approximately 40 sessions of activity-based locomotor training in combination with the stimulation. Their cumulative response of stimulation (i.e. safety, comfort, feasibility) across time will be documented. Participation in this study may last up to 3 days for the 8 participants being observed for acute response to stimulation and up to 9 weeks for the participants being observed for cumulative response to training with stimulation. We will monitor the participants throughout the testing and training for their response to the stimulation (i.e. safety) and their comfort.

Conditions

Spinal Cord Injuries

Keywords

pediatric-onset; transcutaneous spinal stimulation; trunk control

Outcome Measures

Primary Outcomes (6)

• Incidence of skin irritation

  Skin color, particularly change in skin color to pink indicating irritation in the location of the stimulating electrode placement will be assessed prior to stimulation experiments and immediately after; incidence of pink- or redness or irritation and time (minutes-days) to dissipation will be recorded.

  1 week for Aim 1, 9 weeks for Aim 2

• Faces Pain Scale-Revised (scale 0-10)

  Faces Pain Scale - Revised is a self-report measure of pain intensity developed for children (C.L. Hicks et al. Pain 93 (2001). It will be used to score the sensation of pain on 0 (min - no pain)-to-10 (max - worst pain ever) metric. The scale depicts 6 facial expressions: first - face with a neutral expression corresponds to pain score of 0, next facial expression is scored as 2, etc. The faces scale will be presented to the participant (ages 3-8) prior to the experiment for baseline measurement, during stimulation and following the experiment.

  1 week for Aim 1, 9 weeks for Aim 2

• Visual Analog Scale (0-10)

  To assess pain in the participants ages 8 and above, Visual Analog Scale (self-reported measure) will be presented with 0 corresponding to no pain and 10 corresponding to the "worst pain ever"; the scale will be presented at baseline measurement, during stimulation and following the experiment.

  1 week for Aim 1, 9 weeks for Aim 2

• Blood pressure

  continuous beat-by-beat blood pressure (mmHg) recordings will be made using Finapress finger cuff system for 5 minutes prior to and 5 minutes immediately following stimulation while the child is sitting; Brachial arm blood pressure will be periodically measured during stimulation (mmHg). systolic and diastolic blood pressure values will be compared with the established norms for typically developing children (age and height matched);

  1 week for Aim 1, 9 weeks for Aim 2

• number of requests to stop the stimulation

  Number of participants requesting (or number of request per participant within experimental sessions) to stop stimulation due to pain, fatigue or any other reason (documented)

  1 week for Aim 1, 9 weeks for Aim 2

• Angular excursions of trunk during trunk control assessments

  trunk kinematics (degrees of flexion/extension) in cervical, thoracic and lumbar regions;

  3 days for Aim 1, 9 weeks for Aim 2

Secondary Outcomes (3)

• Heart rate

  1 week for Aim 1, 9 weeks for Aim 2

• Compliance rate

  1 week for Aim 1, 9 weeks for Aim 2

• Center of pressure displacement during trunk control assessment

  1 week for Aim 1, 9 weeks for Aim 2

Study Arms (1)

Transcutaneous spinal stimulation

EXPERIMENTAL

Safety and feasibility outcome measures are collected during application of transcutaneous spinal stimulation while trunk control is assessed at 3 time points (acute) and/or while transcutaneous stimulation is applied in combination with activity-based locomotor training (40 sessions, 1.5 hours/day, 5 days/week; stimulation will be applied intermittently for no more than 10 minutes at a time during training)

Device: Transcutaneous Spinal Stimulation

Interventions

Transcutaneous Spinal Stimulation DEVICE

Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury

Transcutaneous spinal stimulation

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• history of chronic, acquired upper motor neuron SCI (traumatic or non-traumatic);
• discharged from in-patient rehabilitation
• moderate to severe trunk control deficit as either documented with the Segmental Assessment of Trunk Control (SATCo, score \< 15/20) or reported/observed inability to sit fully upright and without use of arm support
• history of completion of a minimum of 60 sessions of activity-based locomotor training/therapy at Frazier Rehab

You may not qualify if:

• botox use within past 3 months;
• current baclofen use
• unhealed fracture
• any other medical complication limiting participation in the assessments and/or activity-based locomotor training;
• prior surgery for scoliosis;
• congenital SCI
• total ventilator dependence

Sponsors & Collaborators

• University of Louisville: lead
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

Kentucky Spinal Cord Injury Res Center, University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Keller A, Singh G, Sommerfeld JH, King M, Parikh P, Ugiliweneza B, D'Amico J, Gerasimenko Y, Behrman AL. Noninvasive spinal stimulation safely enables upright posture in children with spinal cord injury. Nat Commun. 2021 Oct 6;12(1):5850. doi: 10.1038/s41467-021-26026-z.

  PMID: 34615867 DERIVED

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, PhD, PT

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: June 5, 2019
• Study Start: August 12, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2025
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)