Spinal Cord Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Ismael Seanez, PHD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Analgesics, Caffeine

Disqualifiers: Pain, Neurologic disease, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how spinal cord stimulation, combined with various physical training types, can improve movement for people with spinal cord injuries. Researchers aim to understand how these treatments affect nerve circuits and assist with motor function. Participants will be divided into groups to try spinal cord stimulation alone, activity-based training (a type of neurological rehabilitation training), or a combination of both. The trial targets individuals who have experienced a traumatic spinal cord injury from the neck to the upper back, have been injured for at least a year, and struggle to move their legs independently in daily life. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance mobility and quality of life.

Will I have to stop taking my current medications?

The trial requires that you do not use analgesics (pain relievers) within 24 hours before the study period. Other medications are not specifically mentioned, so it's best to discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both transcutaneous spinal cord stimulation (TSCS) and activity-based training (ABT) are generally safe for people. Studies have found that TSCS is safe and practical for children with spinal cord injuries, enhancing their strength and function without major side effects. Research indicates that ABT can be safely initiated soon after a spinal cord injury, with no major negative effects reported. Combining TSCS with ABT has also proven safe and effective for adults with long-term spinal cord injuries. Overall, these treatments are well-tolerated and have a strong safety record in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for spinal cord injury because they explore non-invasive spinal cord stimulation combined with activity-based training to potentially improve motor function. Unlike standard treatments, which often focus on rehabilitation exercises alone, this approach uses electrical stimulation to activate nerve circuits, which could enhance recovery. Moreover, integrating stimulation with precision training or long-term activity-based programs might offer more comprehensive benefits by targeting both strength and dexterity. This innovative method could represent a significant advancement in improving mobility and quality of life for individuals with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS), which participants in this trial may receive, can improve movement and walking, especially after spinal cord injuries. Some studies suggest that combining tSCS with activity-based training (ABT), another treatment option in this trial, can further enhance recovery. This combination has effectively increased mobility for people with long-term spinal cord injuries. Even on its own, activity-based training has improved independence and mobility in various groups of spinal cord injury patients. Overall, these treatments offer promising ways to regain movement and function. ^{6 7 8 9 10}

Who Is on the Research Team?

Ismael Seanez, PhD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 16-65 with a traumatic spinal cord injury between C4-T9 levels, classified as ASIA C or D. They should have difficulty moving their legs independently and be at least one year post-injury. Healthy volunteers in the same age range without major health issues can also participate. Exclusions include severe comorbidities, implanted devices like pacemakers, drug use affecting the study, pregnancy, uncontrolled infections or illnesses that could interfere with exercises.

Inclusion Criteria

I am between 16 and 65 years old and do not have any major health issues.

I am 16-65 with a spinal injury at C4-T9, can follow commands, and have trouble moving my legs.

Exclusion Criteria

Healthy Volunteers younger than 16 or older than 65 years old, not providing consent or not able to consent, with any acute or chronic pain condition, with any acute or chronic disease of a major organ system, use of analgesics within 24 hours prior to the study period, use of caffeine within 3 hours of the study appointment

Participants with spinal cord injury (SCI) younger than 16 or older than 65 years old, not willing or able to provide consent, with any acute or chronic pain condition, with any acute or chronic disease of a major organ system, use of analgesics within 24 hours prior to the study appointment, use of caffeine within 3 hours of the study appointment, presence of tremors, spasms, and other significant involuntary movements, etiology of SCI other than trauma, concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy, history of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc.), severe joint contractures disabling or restricting lower limb movements, unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities, depression, anxiety, or cognitive impairment, deficit of visuospatial orientation, sitting tolerance less than 1 hour, severe hearing or visual deficiency, miss more than 3 appointments without notification, unable to comply with any of the procedures in the protocol, botulinum toxin injection in lower extremity muscles in the prior six months, any passive implants (osteosynthesis material, metallic plates or screws) below T9, any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.), history of alcoholism or another drug abuse, pregnancy (or possible pregnancy), having an Intrathecal Baclofen Therapy Pump (ITB pump), history of epilepsy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Short-term Intervention

Participants receive 30 minutes of transcutaneous spinal cord stimulation and/or activity-based training to assess short-term neural excitability changes

30 minutes

1 visit (in-person)

Long-term Training

Participants undergo 4 weeks of activity-based training with transcutaneous spinal cord stimulation to assess long-term neural plasticity changes

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Activity-based training
• Electrophysiology assessment - corticospinal tract
• Electrophysiology assessment - reticulospinal tract
• Electrophysiology assessment - spinal motoneuron
• Transcutaneous spinal cord stimulation

Trial Overview

The study examines how spinal cord stimulation (SCS) affects motor function recovery in people with spinal injuries by assessing changes in neural circuits' excitability and plasticity. It involves electrophysiology assessments of different neural tracts and activity-based training combined with transcutaneous SCS.

How Is the Trial Designed?

Group I: Experimental: Non-invasive spinal cord stimulation and strength training Experimental Treatment 5 Interventions

This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.

Group II: Experimental: Non-invasive spinal cord stimulation and precision training Experimental Treatment 5 Interventions

This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.

Group III: Experimental: Non-invasive spinal cord stimulation Experimental Treatment 4 Interventions

This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.

Group IV: Experimental: Long-term activity-based training with non-invasive spinal cord stimulation Experimental Treatment 5 Interventions

This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation

Group V: Experimental: Activity-based training wtih non-invasive spinal cord stimulation Experimental Treatment 5 Interventions

This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.

Group VI: Experimental: Activity-based training Experimental Treatment 4 Interventions

This arm will perform 30 minutes of activity-based training using leg movements.

Activity-based training is already approved in United States, European Union for the following indications:

Approved in United States as Activity-Based Training for:

• Spinal cord injury recovery
• Traumatic brain injury rehabilitation
• Neurological condition management

Approved in European Union as Activity-Based Training for:

• Spinal cord injury rehabilitation
• Neurological condition management
• Physical therapy for neurological disorders

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) can non-invasively enhance sensorimotor rehabilitation by modulating spinal cord circuitry, showing promise for improving recovery after spinal cord injuries.

Single-site tSCS can influence excitability across multiple spinal cord segments, while multi-site tSCS can enhance spinal reflexes and corticospinal networks, indicating its potential for more effective rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. Barss, TS., Parhizi, B., Porter, J., et al.[2022]

A multicenter randomized clinical trial is investigating the effectiveness of combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) for improving upper extremity function in individuals with cervical spinal cord injury, showing promising preliminary results.

In a small sample of four participants, the combination of scTS and ABT led to immediate and sustained improvements in upper extremity function, with one participant experiencing a remarkable 5-fold increase in function, indicating potential for significant rehabilitation benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining Spinal Cord Transcutaneous Stimulation with Activity-based Training to Improve Upper Extremity Function Following Cervical Spinal Cord Injury. Zhang, F., Carnahan, J., Ravi, M., et al.[2023]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

Transcutaneous spinal cord stimulation (TSS) significantly affects brain activity, activating key areas related to movement control and planning, as shown by EEG analysis in five participants performing lower-limb tasks.

TSS resulted in notable changes in functional connectivity in the brain during stimulation, unlike functional electrical stimulation (FES), suggesting TSS may be more effective for enhancing cortical engagement in rehabilitation strategies for spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. Steele, AG., Manson, GA., Horner, PJ., et al.[2022]

Activity-Based Restorative Therapies (ABRT) is a promising approach for improving recovery in individuals with spinal cord injury (SCI) by utilizing neuroplasticity principles and focusing on repetitive, task-specific training.

ABRT incorporates key components like weight-bearing activities and functional electrical stimulation, which have been shown to enhance functional mobility and reduce the risk of secondary health issues after SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activity-Based Restorative Therapies after Spinal Cord Injury: Inter-institutional conceptions and perceptions. Dolbow, DR., Gorgey, AS., Recio, AC., et al.[2020]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

In a study involving 15 participants with chronic spinal cord injury, a 2-hour session of activity-based therapy (ABT) did not lead to acute changes in brain-derived neurotrophic factor (BDNF) levels, which are important for neuroplasticity.

However, the therapy did result in a significant reduction in prolactin levels, suggesting that ABT may influence other neurobiological pathways, although further research is needed to explore the effects of different intensities or modalities on BDNF levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in neuroplasticity-related proteins in response to acute activity-based therapy in persons with spinal cord injury. Harness, ET., Astorino, TA., Knoblach, SM., et al.[2018]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

Spasticity affects 65-70% of individuals after spinal cord injury, and combining spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) may help reduce this condition.

Preliminary data suggests that neuromodulation through scTS can improve neurorehabilitation outcomes by potentially decreasing spasticity, which is crucial for enhancing function in people with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation with Activity-Based Training: Effect on Spasticity. Bheemreddy, A., Anjaria, M., Bayram, M., et al.[2023]

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Therapy + Stimulation for Spinal Cord Injury

Additionally, studies on ABT suggest it is aimed at regaining motor and sensory function through repetitive training, which is generally considered safe.