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

Trial Summary

What is the purpose of this trial?

Transcutaneous electrical stimulation (tcES) of the spinal cord has shown great promise in restoring upper extremity function after spinal cord injury (SCI). More recently, the use of invasive, epidural electrical stimulation of the spinal cord has also demonstrated promise in restoring upper extremity function post-stroke. However, the effect of stimulation parameters such as electrode configuration and stimulation frequency on excitability of the nervous system remains unknown preventing the opportunity to fully exploit this noninvasive stimulation paradigm. Additionally, the utility of noninvasive tcES in the stroke population remains unexplored. This project utilizes a comprehensive set of neurophysiological techniques, in combination with carefully chosen motor tasks, to directly link and assess the effects of stimulation parameters on neural excitability and upper extremity function during and following the delivery of cervical tcES in individuals with SCI and stroke. The fundamental knowledge gained from this project will ultimately improve the implementation of this novel and non-invasive neuromodulatory tool through an improved understanding of how tcES can facilitate recovery of function.

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 data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation for improving upper extremity function?

Research shows that transcutaneous spinal cord stimulation (tSCS) can help improve movement and recovery in people with spinal cord injuries by stimulating the spinal cord non-invasively. Studies have found that tSCS can enhance motor recovery and sensorimotor function, suggesting it may be effective for improving upper limb function. ^{1 2 3 4 5}

Is transcutaneous spinal cord stimulation safe for humans?

Research indicates that transcutaneous spinal cord stimulation (tSCS) is generally considered safe for humans, as it is a non-invasive technique used to stimulate the spinal cord and has been evaluated in various studies without significant safety concerns. ^{1 4 6 7 8}

How is transcutaneous spinal cord stimulation (tSCS) different from other treatments for improving upper extremity function?

Transcutaneous spinal cord stimulation (tSCS) is unique because it is a non-invasive treatment that uses electrodes placed on the skin to stimulate the spinal cord, potentially enhancing motor function and strength in both upper and lower limbs. Unlike other treatments, tSCS can modulate spinal cord circuitry without surgery, offering a novel approach to rehabilitation for individuals with spinal cord injuries. ^{1 2 4 5 9}

Research Team

Jessica D'Amico, PhD

Principal Investigator

University of Alberta

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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]

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 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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]

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

Neural Substrates of Transcutaneous Spinal Cord Stimulation: Neuromodulation across Multiple Segments of the Spinal Cord. [2022]

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

Enhanced selectivity of transcutaneous spinal cord stimulation by multielectrode configuration. [2023]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

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

Effects of transcutaneous spinal stimulation on spatiotemporal cortical activation patterns: a proof-of-concept EEG study. [2022]

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

Spinal Direct Current Stimulation Modulates Short Intracortical Inhibition. [2022]

8. Switzerland 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. [2023]

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

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]