Non-invasive Spinal Stimulation for Spinal Cord Injury

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Botox, Baclofen

Disqualifiers: Musculoskeletal impairment, Scoliosis surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 65

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help children with spinal cord injuries improve sitting posture and trunk control. Researchers combine two treatments: activity-based exercises and a non-invasive device called the Biostim-5/Neostim transcutaneous spinal stimulator, which sends gentle electrical signals to the spine. It targets children aged 3–12 who have had a spinal cord injury for over a year, cannot walk, and struggle to sit upright. Children who have not tried these specific treatments and have difficulty with trunk control may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for children to potentially benefit from innovative treatments tailored to their needs.

Will I have to stop taking my current medications?

If you are currently using oral baclofen, you will need to stop taking it and wean off under medical guidance to participate in the trial.

What prior data suggests that this method is safe for children with spinal cord injury?

Research has shown that devices like the Biostim-5/Neostim for spinal stimulation are generally safe and have few complications. Studies have found that this treatment is well-tolerated, especially in children with spinal cord injuries. One study provided the first evidence that this method is safe for children, demonstrating successful application.

When combined with activity-based training, this stimulation has shown promising results. This combination can improve trunk control in children with spinal cord injuries, though it may not lead to complete recovery. Importantly, past participants completed multiple sessions of this combined treatment without major problems. This suggests that the treatment is not only safe but also potentially helpful for improving function after a spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for spinal cord injury, which often involve surgery or medication, the Biostim-5/Neostim transcutaneous spinal stimulator offers a non-invasive approach. This device delivers electrical stimulation through the skin, aiming to enhance nerve function and promote movement without the need for surgical intervention. Researchers are excited about this treatment because it combines spinal stimulation with activity-based locomotor training, potentially leading to improved mobility and independence for individuals with chronic spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for improving sitting posture and trunk control in children with chronic spinal cord injury?

Studies have shown that transcutaneous spinal cord stimulation, a non-invasive method using electrical currents, can improve muscle strength and function in people with spinal cord injuries. In this trial, participants will receive transcutaneous spinal stimulation combined with activity-based locomotor training. Research suggests that this stimulation can also enhance breathing muscle function, aiding in sitting posture and trunk control. The treatment sends electrical signals through the skin to activate nerve pathways in the spinal cord, improving nervous system communication and potentially enhancing movement. Initial findings indicate that combining this stimulation with exercises could be effective for rehabilitation in children with spinal injuries. ^{1 6 7 8 9}

Who Is on the Research Team?

Andrea L Behrman, PT, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been discharged from in-patient rehab.

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

I have had an upper body nerve injury for over a year.

Exclusion Criteria

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

My spinal cord injury is due to Spina Bifida.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments for clinical and biomechanical outcomes

1 week

2 visits (in-person)

Treatment

Participants receive 60 sessions of activity-based locomotor training combined with transcutaneous spinal stimulation

12 weeks

60 visits (in-person, 5 days/week)

Post-Treatment Assessment

Participants are assessed for changes in trunk control and posture after completing the treatment sessions

1 week

2 visits (in-person)

Follow-up

Participants are monitored for the durability of training effects and responsiveness of clinical outcome measures

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biostim-5/Neostim transcutaneous spinal stimulator

Trial Overview 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.

How Is the Trial Designed?

Group I: Transcutaneous spinal stimulation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

The Craig H. Neilsen Foundation

Collaborator

Trials

62

Recruited

3,100+

Published Research Related to This Trial

Epidural electrical stimulation and transcutaneous spinal cord stimulation (SCS) both effectively activate similar neural pathways in the lumbar spinal cord, as evidenced by comparable electromyographic (EMG) responses in individuals with spinal cord injury (SCI).

The study confirmed that both stimulation techniques produce similar muscle responses, supporting the idea that transcutaneous SCS can be a noninvasive alternative to epidural stimulation for enhancing motor function in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Common neural structures activated by epidural and transcutaneous lumbar spinal cord stimulation: Elicitation of posterior root-muscle reflexes. Hofstoetter, US., Freundl, B., Binder, H., et al.[2019]

Cervical intraspinal microstimulation (ISMS) shows promise in improving forelimb function after incomplete spinal cord injuries, suggesting it can activate spinal circuits below the injury site.

Therapeutic ISMS may support long-term recovery by promoting neuron survival and growth, indicating its potential as a treatment for enhancing motor control in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic intraspinal stimulation to generate activity and promote long-term recovery. Mondello, SE., Kasten, MR., Horner, PJ., et al.[2021]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

The Parastep method, a functional electrical stimulation device, enabled 13 out of 15 spinal cord-injured patients to achieve independent ambulation with a walker after an average of 20 training sessions, demonstrating its potential for improving mobility.

Despite its benefits, the Parastep method has limited applications for daily mobility due to high energy costs and cardiovascular strain, although it can still provide significant psychological and physical fitness benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. Brissot, R., Gallien, P., Le Bot, MP., et al.[2019]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452666/

Transcutaneous Spinal Cord Stimulation Improves ... Transcutaneous spinal cord stimulation improves respiratory muscle strength and function in subjects with cervical spinal cord injury.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05731986

Spinal Cord Transcutaneous Stimulation Effect on Blood ... The goal of this clinical trial is to evaluate the effect of transcutaneous spinal cord stimulation on blood pressure in individuals with an acute spinal ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11462428/

Neuromodulation in Spinal Cord Injury Using ... The primary outcome was the impact of stimulation on SBP. Utilizing the calibrated data, the collected information for participants for each stimulated location ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05157282

Study Details | NCT05157282 | Spinal Cord Stimulation for ... Current studies demonstrate that electrical spinal stimulation, either invasive or noninvasive, can play an important role in rehabilitation strategies aimed at ...

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-7-2021-9febb

Non-invasive Spinal Stimulation for Spinal Cord Injury This trial tests a combination of exercises and electrical stimulation to improve sitting and trunk control in children with severe spinal injuries.

6. liebertpub.com liebertpub.com/doi/10.1177/08977151251371710?doi=10.1177/08977151251371710

Combining Therapeutic Strategies to Treat the Injured Spinal Cord It is widely recognized that combinations of treatments will be needed to achieve effective recovery from a spinal cord injury (SCI). In the past three decades, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293838/

Cumulative Transcutaneous Spinal Stimulation with ... Conclusions: These findings provide the first evidence supporting the safety and feasibility of this combinatorial approach in pediatric SCI ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03975634

Transcutaneous Spinal Stimulation: Safety and Feasibility ... Activity-based locomotor training has resulted in improved trunk control in children with spinal cord injury, though full recovery is not achieved in all ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998450

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...