Spinal Cord Stimulation + Training for Spinal Cord Injury

Overseen By Gail Forrest, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Anti-spasticity medications

Disqualifiers: Seizures, Head trauma, Cognitive deficit, others

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

Compensation: Varies

Number of Visits: 13

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and practicality of using spinal cord transcutaneous stimulation (a non-invasive technique) combined with activity-based training to help individuals with recent spinal cord injuries improve arm, hand, and trunk function. It tests three approaches: the combination of stimulation and training, a placebo version, and training alone. Participants will engage in 10 sessions over two weeks, with follow-up visits to assess progress. Ideal candidates are those who have sustained a spinal cord injury in the neck area within the last eight weeks and experience difficulty using their hands.

As an unphased trial, this study provides a unique opportunity to contribute to pioneering research that could enhance rehabilitation options for spinal cord injury patients.

Will I have to stop taking my current medications?

The trial requires participants to stop taking anti-spasticity medications (like baclofen, Xeomin, and Lioresal) if they are unable or unwilling to wean off them.

What prior data suggests that spinal cord transcutaneous stimulation combined with activity-based training is safe for individuals with spinal cord injury?

Research has shown that spinal cord transcutaneous stimulation (scTS) is generally safe for people with spinal cord injuries. Studies have found that combining scTS with activity-based training (ABT) poses no major problems. For example, patients in various studies did not experience serious side effects. Some minor issues, such as skin irritation, were noted but remained manageable.

Activity-based training alone has also been evaluated for safety. Results indicate that it is well-tolerated even shortly after severe spinal cord injuries, with no serious side effects reported in early sessions.

Overall, both treatments appear safe and manageable for participants. They are carefully used to help improve movement and strength. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord transcutaneous stimulation (scTS) combined with activity-based training (ABT) for spinal cord injury because it offers a unique approach that differs from traditional rehabilitation methods. Unlike other treatments, which often focus solely on physical therapy, this method uses customized electrical stimulation to target specific spinal segments, potentially enhancing neural plasticity and recovery. The stimulation is applied non-invasively through electrodes placed on the skin, making it less intrusive than surgical options. Additionally, by combining scTS with ABT, there's potential for improved motor function and quality of life, as the stimulation might amplify the benefits of physical training.

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

Research has shown that spinal cord transcutaneous stimulation (scTS) combined with activity-based training (ABT) may improve hand and arm function in people with spinal cord injuries. In this trial, one group will receive active scTS with ABT, while another group will receive sham scTS with ABT to control for placebo effects. In one study, 72% of participants experienced improved strength and function in their hands and arms with the combination of scTS and ABT. Another study found that scTS with ABT led to significant recovery in people with long-term spinal cord injuries, although it required several sessions. These findings suggest that this combined approach might lead to better recovery than traditional methods. ^{6 7 8 9 10}

Who Is on the Research Team?

Gail Forrest, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for individuals with recent cervical spinal cord injuries who are currently in an inpatient rehabilitation program. It's designed to see if a combination of skin-level spinal stimulation and activity-based training can help improve the use of their hands, arms, and trunk.

Inclusion Criteria

I can understand and am willing to sign the informed consent.

My spinal cord injury is in the neck area and is severe.

I am medically fit to engage in physical recovery activities.

Exclusion Criteria

Unable to meet the attendance requirements

Currently enrolled in another interventional research study

I struggle to stay alert or follow instructions during medical assessments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the three interventions (scTS+ABT, sham scTS+ABT, or ABT only) for 10 sessions over 2 weeks.

2 weeks

10 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1-month, 2-month, and 3-month follow-up visits.

3 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Activity-based Training
• Spinal Cord Transcutaneous Stimulation

Trial Overview

The study tests three different interventions: actual spinal stimulation combined with training (scTS+ABT), fake stimulation with training (sham scTS+ABT), and just the training on its own (ABT only). Participants will be randomly assigned to one group for ten sessions over two weeks.

How Is the Trial Designed?

Group I: Activity-based Training Only Experimental Treatment 1 Intervention

Participants in ABT group will receive ABT only. ABT will concentrate on activities of gross UE movement, grasping, pinching, gross and fine motor skill. The hand grasp task will focus on grasping objects with different shapes and weights (i.e. weighted container and tennis ball) and placing/removing them from small storage container; the pinch task involves picking up, translating, and releasing small objects with varied sizes (i.e. blocks, dices, marble balls, nuts, etc.). The training therapist selects tasks based on participant's level of impairment and individual goals. The dosage of ABT will be 30 minutes/session, with approximately 15 minutes allocated on each side.

Group II: Active Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training Active Control 1 Intervention

Participants will receive activity-based training (ABT) while receiving concomitant, active spinal stimulation (scTS) applied at the cervical and thoracic spinal segments over the dorsal skin with optimized and customized stimulation parameters. Round self-adhesive electrodes will be placed over the skin at the midline of spinous processes as cathodes and a pair of rectangular anodes electrodes will be placed over the anterior iliac crests of the pelvis. The stimulation waveform is rectangular pulse with 1-ms duration filled with a carrier frequency of 5kHz. Target simulation will be sub-threshold for UE muscle activation and verified by the absence of visible muscle contraction. The stimulation parameters will be adjusted as needed throughout the intervention course based on the participant's performance and comfort level. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.

Group III: Sham Spinal Cord Transcutaneous Stimulation Combined with Activity-based Training Placebo Group 1 Intervention

The sham-control group will go through ABT paired with sham stimulation to control for placebo effects associated with the perception of scTS. Stimulation will be delivered at one cervical location. No stimulation mapping procedure will be performed. During the training session, the stimulation intensity will be briefly ramped up to a level at which the participants report perceiving the stimulation, and then ramped down to 0mA at both the start and the end of session. The stimulator and electrodes will remain attached to the participant while receiving ABT training. The intervention will be administered over 2 consecutive weeks, for 30mins/session and 5 sessions/week, as a part of their daily 3-hour therapy.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Transcutaneous electrical stimulation of the spinal cord (TESS) significantly enhances motor-evoked potentials in arm muscles for up to 75 minutes after stimulation, indicating its potential to promote functional recovery in individuals with spinal cord injury (SCI).

The study found that TESS has a dual effect: it excites spinal networks while inhibiting cortical activity, which may contribute to improved hand and arm function, especially when using a specific 5 kHz carrier frequency during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical and Subcortical Effects of Transcutaneous Spinal Cord Stimulation in Humans with Tetraplegia. Benavides, FD., Jo, HJ., Lundell, H., et al.[2021]

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]

A case study of a 27-year-old male with chronic spinal cord injury showed that combining locomotor training with multi-segmental spinal cord transcutaneous electrical stimulation (scTS) can enhance recovery of locomotion by reactivating dormant spinal networks.

After a 3-month training regimen, improvements in stepping coordination were observed, indicating that scTS may facilitate neuroplastic changes and better sensory-motor integration, which are crucial for functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Noninvasive Spinal Neuromodulation Strategy Facilitates Recovery of Stepping after Motor Complete Paraplegia. Siu, R., Brown, EH., Mesbah, S., et al.[2022]

Targeted transcutaneous spinal cord stimulation (tSCS) in two individuals with motor-complete spinal cord injury led to a remarkable increase in exerted force by up to 1,136% when combined with weekly activity-based training.

This study is the first to report a significant improvement in tactile sensation, with a 2-point increase in clinical assessments, and the benefits persisted for at least one month after stimulation, indicating potential for lasting recovery of motor and sensory functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. Chandrasekaran, S., Bhagat, NA., Ramdeo, R., et al.[2023]

In a study involving 122 participants with chronic low back and/or leg pain, multiphase spinal cord stimulation (SCS) significantly reduced pain levels, with mean reductions of -4.3 and -4.7 on the numerical rating scale for two different multiphase therapies.

The multiphase SCS therapies were found to be safe, with only one non-serious device-related adverse event reported and no infections, suggesting a favorable safety profile for this new stimulation paradigm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Kapural, L., Patterson, DG., Li, S., et al.[2023]

A new animal model for transcutaneous spinal cord stimulation (tSCS) was developed, which accurately mimics human responses and allows for stable, repeated treatments after spinal cord injury (SCI) with minimal restraint.

The study demonstrated that tSCS can effectively modulate motor output in rats after complete spinal cord transection, suggesting its potential for promoting neuroplasticity and functional recovery in SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. Malloy, DC., Knikou, M., Côté, MP.[2023]

Transvertebral spinal cord stimulation (SCS) was tested in rats and showed specific effects on muscle activation in the lower thoracic and lumbosacral spinal cord, indicating its potential for targeted neuromodulation after spinal cord injuries.

The study found that transvertebral SCS produced similar muscle activation patterns and neuroanatomical effects as traditional transcutaneous stimulation, suggesting it could be an effective alternative for recovery therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping of the Spinal Sensorimotor Network by Transvertebral and Transcutaneous Spinal Cord Stimulation. Shkorbatova, P., Lyakhovetskii, V., Pavlova, N., et al.[2020]

Spinal cord transcutaneous stimulation (scTS) has shown promise in enhancing recovery of motor, sensory, and autonomic functions after spinal cord injuries, but the specific mechanisms behind its effects are not fully understood.

Preliminary findings suggest that scTS-based motor training may differentially affect cortical connectivity and corticospinal excitability in both able-bodied individuals and those with spinal cord injuries, indicating a need for further research to optimize this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Corticospinal Excitability and Cortical Functional Connectivity Modulation by Spinal Cord Transcutaneous Stimulation-based Motor Training versus Motor Training alone in Able-bodied and SCI participants: A Multiple Case Study. Brihmat, N., Bayram, MB., Ravi, M., et al.[2023]

In a study involving 18 individuals with subacute motor-incomplete spinal cord injury, combining locomotor training (LT) with transcutaneous spinal stimulation (TSS) showed promising improvements in walking speed and distance after a 4-week program, although no significant differences were found between the TSS and sham groups.

The results suggest that TSS is a feasible addition to LT during rehabilitation, potentially enhancing walking outcomes, but did not significantly affect spasticity, possibly due to high variability in spasticity measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Transcutaneous Spinal Stimulation and Locomotor Training to Improve Walking Function and Reduce Spasticity in Subacute Spinal Cord Injury: A Randomized Study of Clinical Feasibility and Efficacy. Estes, S., Zarkou, A., Hope, JM., et al.[2022]

In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).

Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]

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