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

Trial Summary

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 data supports the effectiveness of the treatment Upper extremity stimulation, Upper Extremity Training for Spinal Cord Injury?

Research shows that combining upper extremity training with electrical stimulation can improve arm function and strength in people with spinal cord injuries. Studies have found that these treatments can lead to long-lasting improvements in motor control and quality of movement, even after the therapy ends. ^{1 2 3 4 5}

Is upper extremity stimulation safe for humans?

The safety reporting in clinical trials for spinal cord injury treatments, including upper extremity stimulation, is often not optimal, with many studies failing to adequately distinguish severe adverse events. However, some trials have satisfactory reporting of clinical adverse events and discontinuations, suggesting that while safety data is available, it may not always be comprehensive. ^{3 6 7 8 9}

How does Upper Extremity Training differ from other treatments for spinal cord injury?

Upper Extremity Training for spinal cord injury is unique because it combines non-invasive spinal cord transcutaneous stimulation (scTS) with activity-based training (ABT) to enhance recovery of arm function. This approach increases the excitability of spinal circuits and promotes neuroplasticity, leading to sustained improvements in motor and sensory functions, which are not typically achieved with conventional therapies alone. ^{2 5 10 11 12}

What is the purpose of this trial?

This study is to understand how the combination of activity-based recovery training and targeted spinal cord transcutaneous stimulation (scTS) can improve participants' ability to use their hand, arms, and core.

Research Team

Gail F Forrest, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of training on upper limb function after cervical spinal cord injury: a systematic review. [2022]

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

Upper Limb Robotic Rehabilitation for Patients with Cervical Spinal Cord Injury: A Comprehensive Review. [2021]

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

Improving Upper Extremity Strength, Function, and Trunk Stability Using Wide-Pulse Functional Electrical Stimulation in Combination With Functional Task-Specific Practice. [2023]

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

Robot-assisted upper extremity rehabilitation for cervical spinal cord injuries: a systematic scoping review. [2019]

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

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. [2020]

6. England pubmed.ncbi.nlm.nih.gov

International spinal cord injury upper extremity basic data set. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Assessment of the ability of wheelchair subjects with spinal cord injury to perform a specific protocol of shoulder training: a pilot study. [2021]

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

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

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

Systematic review of the effects of exercise therapy on the upper extremity of patients with spinal-cord injury. [2018]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Upper limb effort does not increase maximal voluntary muscle activation in individuals with incomplete spinal cord injury. [2021]

11. Switzerland 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. [2023]

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

Combining Spinal Cord Transcutaneous Stimulation with Activity-based Training to Improve Upper Extremity Function Following Cervical Spinal Cord Injury. [2023]