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

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Biostim-5/Neostim transcutaneous spinal stimulator for spinal cord injury?

Research shows that adding transcutaneous spinal cord stimulation (tSCS) to sit-to-stand training in people with spinal cord injury led to improvements in motor scores and muscle activity in some participants, suggesting potential benefits of this treatment. ^{1 2 3 4 5}

Is non-invasive spinal stimulation generally safe for humans?

Research on spinal cord stimulation, including cervical spinal cord stimulation (cSCS), shows it is generally safe with low rates of complications. For example, a study found a 0.5% rate of spinal cord injury and no deaths among 2053 cases. Another study on cSCS for aneurysmal subarachnoid hemorrhage patients reported no complications or long-term side effects during a one-year follow-up. ^{6 7 8 9 10}

How does non-invasive spinal stimulation differ from other treatments for spinal cord injury?

Non-invasive spinal stimulation is unique because it uses surface electrodes to stimulate the spinal cord without surgery, targeting both ventral and dorsal nerve roots to activate spared neural circuits. This approach is different from traditional methods like epidural stimulation, which requires surgical implantation, and it offers a safer, more accessible option for patients. ^{2 5 11 12 13}

Research Team

Andrea L Behrman, PT, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fantastic Four: Age, Spinal Cord Stimulator Waveform, Pain Localization and History of Spine Surgery Influence the Odds of Successful Spinal Cord Stimulator Trial. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic intraspinal stimulation to generate activity and promote long-term recovery. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Adding Transcutaneous Spinal Cord Stimulation (tSCS) to Sit-To-Stand Training in People with Spinal Cord Injury: A Pilot Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Pain tolerance threshold: a pilot study of an objective measurement of spinal cord stimulator trial results. [2004]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Use of cervical spinal cord stimulation in treatment and prevention of arterial vasospasm after aneurysmal subarachnoid hemorrhage. Technical details. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Evaluating the incidence of spinal cord injury after spinal cord stimulator implant: an updated retrospective review. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Provides Pain Relief with Improved Psychosocial Function: Results from EMP3OWER. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Posteroanterior cervical transcutaneous spinal stimulation targets ventral and dorsal nerve roots. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Clinical experience with functional electrical stimulation-assisted gait with Parastep in spinal cord-injured patients. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Common neural structures activated by epidural and transcutaneous lumbar spinal cord stimulation: Elicitation of posterior root-muscle reflexes. [2019]