Upper Extremity Stimulation for Spinal Cord Injury

Overseen By LeighAnn Martinez, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Anti-spasticity medications

Disqualifiers: Ventilator dependent, Fractures, Cardiac, others

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

Compensation: Varies

Number of Visits: 6

Duration: 20-60 sessions over approximately 5 months

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how combining activity-based recovery training with targeted spinal cord transcutaneous stimulation (scTS) can improve the use of hands, arms, and core muscles in people with spinal cord injuries. The treatment involves sessions of varying lengths using non-invasive stimulation techniques. It suits participants who have had a spinal cord injury at the neck level for at least six months and experience difficulty with arm and hand movements. As an unphased trial, this study offers participants a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation methods for spinal cord injuries.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you must be able to wean off anti-spasticity medication. If you have an implanted pump or have had Botox injections in the last 12 months, you may not be eligible.

What prior data suggests that upper extremity stimulation and training are safe for improving hand, arm, and core function in spinal cord injury patients?

Research has shown that transcutaneous spinal cord stimulation (scTS) is generally safe. Participants in studies experienced noticeable improvements in arm and hand function. Most handled the treatment well, with no serious side effects reported. For instance, one study found that 72% of participants experienced improved strength and function after treatment. Another study confirmed that using scTS with upper and lower body exercises was safe for individuals with spinal cord injuries. Overall, evidence suggests that scTS is well-tolerated and could be a promising method to enhance upper body function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous stimulation for spinal cord injury because it offers a non-invasive approach to enhancing upper extremity function. Unlike traditional therapies that often involve physical rehabilitation or surgical interventions, this method uses electrical stimulation applied through the skin to activate the nerves and muscles. This innovative technique has the potential to improve motor function with varying session intensities, providing a customizable and less intrusive alternative to existing treatments.

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

Research has shown that transcutaneous spinal cord stimulation (scTS), a treatment available to participants in this trial, can improve hand and arm movements in people with spinal cord injuries. In one study, 72% of participants achieved the main goal of better hand function. Another study found that combining scTS with activity-based exercises aided long-term recovery, particularly for those who completed 60 or more sessions. This treatment appears to enhance the nervous system's ability to heal itself over time. Overall, evidence suggests that scTS could be a promising method for regaining arm and hand use after a spinal cord injury. ^{2 3 4 6 7}

Who Is on the Research Team?

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a spinal cord injury at the neck level for at least 6 months. It aims to help them improve the use of their hands, arms, and core muscles.

Inclusion Criteria

I have a spinal cord injury in my neck area.

I have had a spinal cord injury for at least 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo upper extremity training with transcutaneous spinal stimulation and rehabilitation therapy

20-60 sessions over approximately 5 months

3-4 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Upper extremity stimulation
• Upper Extremity Training

Trial Overview The study tests how well activity-based recovery training combined with targeted spinal cord stimulation can enhance upper body function in individuals with chronic cervical spinal cord injuries.

How Is the Trial Designed?

Group I: transcutaneous stimulation Experimental Treatment 1 Intervention

1. transcutaneous stimulation 60 sessions 2. Transcutaneous stimulation 40sessions 3. Transcutaneous stimulation 20 sessions

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

Transcutaneous electrical spinal cord stimulation combined with physical therapy led to significant improvements in upper extremity function for a 62-year-old male with a chronic incomplete spinal cord injury, including a 52-point increase in strength and sensation scores after four weeks of treatment.

Remarkably, the functional gains achieved persisted for over three months after the treatment ended, indicating that this noninvasive approach can promote lasting neuroplasticity and recovery in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. Inanici, F., Samejima, S., Gad, P., et al.[2020]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6986544/

Transcutaneous Electrical Spinal Stimulation Promotes Long ... These data suggest that noninvasive electrical stimulation of spinal networks can promote neuroplasticity and long-term recovery following SCI.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

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 ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000205724

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Of sixty participants who completed the in-clinic ARCEX Therapy phase, 72% met the predefined primary effectiveness endpoint. CUE-T scores and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9396932/

Transcutaneous Electrical Spinal Cord Stimulation to ... TSCS has also been shown to improve LE function and standing ability after SCI (5, 13). Gerassimenko et al. (5) reported on five individuals ...

5. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

6. 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 ...

7. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... Augmenting UE and LE training using TSCS in the clinical setting was shown to be safe and feasible in seven individuals with SCI who had already ...