What side effects are associated with this type of intervention?

The known side effects of treatments similar to Activity-Based Locomotor Training (ABLT) and Transcutaneous Spinal Stimulation (scTS) for Spinal Cord Injury (SCI) include mild device-associated adverse events such as a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. There were no serious adverse events reported for these treatments.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments that directly mirror the combination of Activity-Based Locomotor Training (ABLT) and Transcutaneous Spinal Stimulation (scTS) for spinal cord injury (SCI). However, various neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), have been explored for their potential benefits in neural activation and motor control. These methods aim to enhance motor function through non-invasive electrical stimulation, similar to scTS. While these techniques show promise, they are generally used for other conditions like chronic pain and migraine, and their application in SCI is still under investigation.

What other types of research exist?

Promising, novel alternatives to Activity-Based Locomotor Training (ABLT) and Transcutaneous Spinal Stimulation (scTS) for Spinal Cord Injury (SCI) patients include: 1. Exoskeleton-assisted walking therapy, which uses wearable robotic devices to facilitate movement and improve gait. 2. Epidural electrical stimulation (EES), which involves implanting electrodes near the spinal cord to enhance motor function and neural activation. 3. Brain-computer interface (BCI) systems, which enable direct communication between the brain and external devices to assist in motor control and rehabilitation. 4. Virtual reality (VR)-based rehabilitation, which provides immersive, task-specific training environments to enhance motor learning and engagement.

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Non-invasive Spinal Stimulation for Spinal Cord Injury

N/A

Waitlist Available

Led By Andrea L Behrman, PT, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Musculoskeletal impairment limiting range of motion, unhealed fracture, or other medical complication limiting participation

Spina Bifida as etiology of spinal cord injury

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of exercises and electrical stimulation to improve sitting and trunk control in children with severe spinal injuries. It targets children aged 3-12 who cannot walk due to their injuries. The treatment aims to strengthen muscles and activate nerves to improve posture and control.

Who is the study for?

This trial is for children aged 3-12 with chronic spinal cord injuries at T10 or above, who are not able to walk and have moderate to severe trunk control issues. They should be new to both activity-based locomotor training and transcutaneous spinal stimulation, and must have been out of in-patient rehab for over a year.

What is being tested?

The study tests if combining locomotor training with non-invasive spinal stimulation can help improve sitting posture and trunk control in kids with long-term spinal cord injuries. It will involve 12 participants who haven't tried this method before.

What are the potential side effects?

Potential side effects aren't specified here, but similar treatments may cause discomfort at the stimulation site, skin irritation, or muscle fatigue during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been discharged from in-patient rehab.

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I struggle with sitting up straight or reaching without losing my balance.

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I have never had locomotor training or spinal stimulation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a physical condition that limits my movement or an unhealed fracture.

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My spinal cord injury is due to Spina Bifida.

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I am currently taking oral baclofen and cannot or do not want to stop under a doctor's advice.

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I have had surgery for scoliosis.

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I am not willing to stop using my back brace during the study.

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I have not used Botox in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (pre-intervention), after 60 intervention sessions (each session is 1.5 hours) and 3 months after 60 sessions end for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Modified Function Reach (MFR)

Segmental Assessment of Trunk Control

Secondary study objectives

Angular Excursions of the Trunk

Center of Pressure (CoP) displacement

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transcutaneous spinal stimulationExperimental Treatment1 Intervention

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

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Activity-Based Locomotor Training (ABLT) and Transcutaneous Spinal Stimulation (scTS) are promising treatments for Spinal Cord Injury (SCI). ABLT enhances motor function through repetitive, task-specific training, which helps re-establish neural pathways and improve muscle strength and coordination. scTS involves non-invasive electrical stimulation of the spinal cord, facilitating neural activation and improving motor control by enhancing the excitability of spinal neurons. These treatments are crucial for SCI patients as they can significantly improve functional outcomes, enhance quality of life, and promote greater independence.