Spinal Cord Stimulation for Upper Extremity Function

Recruiting at 1 trial location

Overseen By Jessica D'Amico, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Alberta

Must not be taking: Seizure threshold reducers

Disqualifiers: Pregnancy, Aphasia, Seizures, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals regain arm and hand movement after a spinal cord injury or stroke. It employs a non-invasive treatment called transcutaneous spinal cord stimulation (tSCS), which delivers small electrical currents to the spinal cord. The goal is to determine the most effective ways to use this treatment to improve arm function. Individuals with a spinal cord injury at the neck level or a stroke affecting arm movement may be suitable candidates, particularly if their condition has been stable for some time. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants the opportunity to contribute to groundbreaking advancements in therapy.

Will I have to stop taking my current medications?

The trial requires that if you are taking medications for muscle relaxation or spasm control, your dose and schedule must be stable for at least 4 weeks before the trial starts. You don't need to stop these medications, but you can't change the dose or schedule right before joining.

What prior data suggests that transcutaneous spinal cord stimulation is safe for restoring upper extremity function?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for individuals with spinal cord injuries. Studies have found that, when combined with rehabilitation exercises, tSCS does not cause serious side effects. It has been tested in various settings, such as clinics and at home, and has improved upper body strength and function.

One study confirmed that tSCS is safe and effective, particularly for enhancing hand and arm functions. This indicates that the treatment is well-tolerated and beneficial without causing significant harm.

In summary, current research supports the safety of tSCS, especially when used with rehabilitation exercises, making it a promising option for improving upper body function after a spinal cord injury. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Transcutaneous Spinal Cord Stimulation (tSCS) is unique because it offers a non-invasive approach to improving upper extremity function, unlike traditional treatments that often rely on physical therapy alone. Researchers are excited about tSCS because it delivers electrical stimulation over the cervical spinal cord, potentially enhancing neural connections and motor function more effectively than standard rehab techniques. This method could provide a significant boost in recovery time and outcomes for individuals with impaired arm and hand mobility.

What evidence suggests that transcutaneous spinal cord stimulation is effective for improving upper extremity function after spinal cord injury or stroke?

Research has shown that transcutaneous spinal cord stimulation (tSCS) can enhance arm and hand movement in individuals with spinal cord injuries (SCI). One study demonstrated that tSCS, when combined with rehabilitation exercises, significantly improved arm and hand function in SCI patients. Another study found tSCS to be safe and effective, providing hope for restoring movement in the arms and hands. This trial will assess the effects of tSCS combined with rehabilitation exercises on upper extremity function. Although the exact effects on stroke patients remain under investigation, the results for SCI patients are promising. ^{3 4 5 6 7}

Who Is on the Research Team?

Jessica D'Amico, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a stroke or spinal cord injury and are seeking to improve their upper extremity function. Specific eligibility criteria details were not provided, so interested participants should inquire further.

Inclusion Criteria

I had a stroke over 6 months ago and still have some arm movement.

I am between 18 and 75 years old with a spinal cord injury from C3 to C8, and it has been over a year since my injury.

My muscle relaxant dosage has been stable for at least 4 weeks.

Exclusion Criteria

I am taking medication that could lower my seizure threshold.

My muscle stiffness is severe.

I have difficulty speaking or understanding language.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive transcutaneous spinal cord stimulation over the cervical spinal cord with upper extremity training utilizing the ReJoyce system

8 weeks

Regular visits for stimulation and training sessions

Follow-up

Participants are monitored for changes in intracortical, corticospinal, and spinal excitability, as well as upper extremity function

6 months

Assessments at baseline, end of intervention, and 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation

Trial Overview The study tests noninvasive transcutaneous electrical stimulation (tcES) of the spinal cord to enhance arm function in those with spinal injuries or post-stroke. It explores how different settings affect nervous system activity and recovery.

How Is the Trial Designed?

Group I: tSCS + Rehab Experimental Treatment 2 Interventions

In this single arm study, individuals will receive transcutaneous spinal cord stimulation over the cervical spinal cord with upper extremity training utilizing the ReJoyce system.

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Glenrose Foundation

Collaborator

Trials

10

Recruited

2,500+

Published Research Related to This Trial

Transcutaneous spinal cord stimulation (tSCS) can enhance muscle recruitment selectivity when using multielectrode configurations, as shown in a study with 16 participants, which may improve rehabilitation outcomes for paralyzed muscles after spinal cord injury.

The study found that spatially selective tSCS activates specific motor neurons through proprioceptive fibers, indicating a mechanism that could lead to more effective rehabilitation protocols targeting single-joint movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. Bryson, N., Lombardi, L., Hawthorn, R., et al.[2023]

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]

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]

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]

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]

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]

Transcutaneous spinal direct current stimulation (tsDCS) is a safe technique that can effectively modulate spinal cord excitability, as shown by changes in motor-evoked potentials (MEPs) in healthy subjects after stimulation.

The study found that cathodal tsDCS increased MEP amplitudes indicating enhanced inhibitory GABA(A)ergic drive, while anodal tsDCS had the opposite effect, suggesting tsDCS could be a promising rehabilitation strategy for patients with acute brain lesions or spinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. Bocci, T., Barloscio, D., Vergari, M., et al.[2022]

In a study involving 22 participants with cervical spinal cord injury, the combination of transcutaneous spinal cord stimulation (tSCS) and an exoskeleton significantly improved upper extremity motor strength and functionality compared to the exoskeleton alone.

The intervention group showed greater enhancements in strength and prehension ability, as measured by the GRASSP assessment, indicating that tSCS can effectively optimize rehabilitation outcomes for individuals with cSCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Cervical Spinal Cord Stimulation Combined with Robotic Exoskeleton Rehabilitation for the Upper Limbs in Subjects with Cervical SCI: Clinical Trial. García-Alén, L., Kumru, H., Castillo-Escario, Y., 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38958629/

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924001119

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

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

Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy ... Transcutaneous Spinal Cord Stimulation (ARC-EX Therapy) Is Safe and Effective at Improving Upper Extremity Function Following Spinal Cord Injury (P7-11.001).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07147816

NCT07147816 | Cervical Transcutaneous SCS for TBI The goal of this study is to test the effects of non-invasive electrical stimulation of the spinal cord (called transcutaneous spinal cord stimulation, ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury. The lack of ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Objective. Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) ...