Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Andrea Maharaj, BSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Intrathecal baclofen

Disqualifiers: Ventilator, Depression, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 19

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how transcutaneous spinal cord stimulation (tSCS) can improve heart and lung functions in individuals with long-term spinal cord injuries. The focus is on those with motor-complete injuries, characterized by a loss of movement and sensation, to determine if tSCS can aid blood flow and breathing. Individuals who have had a spinal cord injury for over a year and have stable condition management might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for those with spinal cord injuries.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using any medication or treatment that the investigator believes is not in your best interest for the study, you may be excluded.

What prior data suggests that transcutaneous spinal cord stimulation is safe for individuals with spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for people with spinal cord injuries. In one study, tSCS proved safe and practical for seven individuals with spinal cord injuries, and they did not report any major problems during the treatment. Another study examined how tSCS affects blood flow and pressure in the spinal cord and checked for any skin issues at the stimulation site. The researchers found that participants tolerated tSCS well, with no serious side effects reported.

Overall, these findings suggest that tSCS is a safe option for people with spinal cord injuries. However, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care options for spinal cord injury, which often involve physical rehabilitation and medications to manage symptoms, Transcutaneous Spinal Cord Stimulation (tSCS) is unique because it stimulates the spinal cord externally without invasive surgery. Researchers are excited about tSCS because it has the potential to improve cardiovascular function in individuals with chronic, motor-complete spinal cord injuries by specifically targeting vascular-related endothelial biomarkers and plasma catecholamines. This novel approach might not only improve blood flow and heart health but could also enhance overall quality of life for patients with spinal cord injuries.

What evidence suggests that transcutaneous spinal cord stimulation is effective for improving cardiovascular and pulmonary function in spinal cord injury?

Research has shown that transcutaneous spinal cord stimulation (tSCS), which participants in this trial will receive, can help people with spinal cord injuries (SCI) regain movement. Studies have found that combining tSCS with activity-based therapy (ABT) enhances movement abilities in those with long-term SCI. Improvements include better upper body control, enhanced leg movement, and easier standing. Typically, at least 60 sessions are needed to achieve these improvements, but additional sessions can provide even greater benefits. Early research also suggests that tSCS might improve heart and lung function in people with SCI by influencing related biological markers. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrei Krassioukov, MD,PhD,FRCPC

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for individuals with chronic motor-complete spinal cord injury who are interested in exploring how a non-invasive treatment called transcutaneous spinal cord stimulation (tSCS) might improve their heart and lung function.

Inclusion Criteria

Resident of British Columbia, Canada with active provincial medical services plan

It has been over a year since my injury or diagnosis and at least 6 months since any spinal surgery.

Willing and able to comply with all clinic visits and study-related procedures

Exclusion Criteria

Presence of severe acute medical issue(s) that in the investigator's judgement would adversely affect the participant's participation in the study (e.g., pressure sore, urinary tract infection, etc.)

Clinically significant, unmanaged, depression (PHQ-9 above 15) or ongoing drug abuse

Use of any medication or treatment that in the opinion of the investigator indicates that it is not in the best interest of the participant to participate in this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 hour

1 visit (in-person)

Baseline Assessments

Baseline functional assessments, questionnaires, and cardiopulmonary assessments

4 visits, approximately 2 hours each

4 visits (in-person)

Treatment

Long-term transcutaneous spinal cord stimulation (tSCS) intervention

6 weeks

Minimum 12 visits (in-person)

Post-intervention Assessments

Post-intervention questionnaires and cardiopulmonary assessments

2 visits, approximately 2-3 hours each

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation (tSCS)

Trial Overview The study tests the effects of tSCS on cardiovascular and pulmonary health by monitoring changes in blood vessel-related markers, stress hormones in the blood, and breathing measurements.

How Is the Trial Designed?

Group I: Transcutaneous spinal cord stimulation (tSCS) Experimental Treatment 1 Intervention

Exploring the mechanisms of SCS for improving cardiovascular function in individuals with chronic, motor-complete SCI by measuring vascular related endothelial biomarkers and plasma catecholamines

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

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]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

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]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Protocol for a Systematic Review and Meta-Analysis - PMC Transcutaneous spinal cord stimulation (tSCS) has emerged as a promising neuromodulation technique for enhancing motor recovery and walking ...

2. 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 ...

3. 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 ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... Enhanced trunk control and stability (9), improved lower extremity (LE) function, locomotor output, and standing (6, 8, 13) as well as reduced ...

5. nature.com nature.com/articles/s41394-020-00359-1

Feasibility and utility of transcutaneous spinal cord ... These data indicate that TSCS is both clinically feasible and may be a useful adjunct to walking-based therapy for individuals with motor iSCI.

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07090473

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... To assess safety, we will quantify the impacts of tSCS on hemodynamics, spinal cord perfusion pressure (SCPP), and monitor for local skin site ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06242873?cond=Spinal%20Cord%20Injury&viewType=Table&rank=6

Transcutaneous Spinal Cord Stimulation in Children With ... We hypothesize that concurrent TSCS and gait training will augment walking function in children with iSCI, as compared to gait training with sham stimulation.