Therapy + Stimulation for Spinal Cord Injury

(ABT-TCSCS Trial)

Overseen By Urvashy Gopaul, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Upper extremity deficit, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 44

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a combination of activity-based therapy and transcutaneous spinal cord stimulation can improve arm and hand movement in individuals with cervical spinal cord injuries. The goal is to determine if these treatments together can ease daily life for those affected by such injuries. It suits individuals who have sustained a spinal cord injury in the neck area, are at least six months post-injury, and have some arm movement but wish to improve it. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could enhance rehabilitation options for spinal cord injuries.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this therapy and stimulation method is safe for spinal cord injury recovery?

Research has shown that combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) has generally been well-tolerated in past studies. Participants who received this combined treatment often experienced improvements in their abilities, especially with enough sessions. While the studies mainly focused on the treatment's effectiveness, they also identified no major safety issues. This suggests the treatment is relatively safe for people with spinal cord injuries. However, like any treatment, minor side effects or risks may occur, so discussing these with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Activity-Based Therapy combined with Transcutaneous Spinal Cord Stimulation because they offer a fresh approach to spinal cord injury recovery. Unlike traditional treatments that focus mainly on managing symptoms, this combination aims to restore function by directly stimulating the spinal cord through the skin. This method could enhance neural recovery and improve motor function more effectively than current rehabilitation techniques. By potentially activating dormant neural pathways, this therapy promises a more dynamic and proactive way to help patients regain movement and independence.

What evidence suggests that Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation is effective for spinal cord injury?

Research has shown that combining activity-based therapy (ABT) with transcutaneous spinal cord stimulation (tSCS) can improve arm and hand function after a spinal cord injury. Participants in this trial will receive this combined treatment. Studies have found that individuals noticed improvements after about 60 sessions, with continued treatment often leading to even better results. This method sends gentle electrical signals through the skin to the spinal cord, helping the body relearn how to use affected muscles. These findings suggest that this combination could be promising for those with long-term spinal cord injuries. ^{1 2 3 4 6}

Who Is on the Research Team?

Sukhvinder Kalsi-Ryan

Principal Investigator

Toronto Rehabilitation Institute

Are You a Good Fit for This Trial?

This trial is for individuals with a cervical spinal cord injury who are looking to improve their arm and hand functions. Specific eligibility details aren't provided, but typically participants must meet certain health conditions.

Inclusion Criteria

A score of 2 - 15 on the upper extremity motor score of the ISNCSCI

A score between 5 - 40 on GRASSP Version 1 Strength on at least one side

I am over 18 years old.

Exclusion Criteria

I have a problem with my arm or hand.

My elbow or wrist is very stiff, limiting its movement by more than half.

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants are assessed for neurological stability using ISNCSCI, GRASSP, SCIM, and TRI-HFT

1 week

1 visit (in-person)

Activity-Based Therapy (ABT)

Participants receive 12 sessions of activity-based therapy over 4 weeks

4 weeks

12 visits (in-person)

ABT and Transcutaneous Spinal Cord Stimulation (TCSCS)

Participants receive 28 sessions of combined ABT and TCSCS over 7 weeks

7 weeks

28 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation

Trial Overview The study explores the effectiveness of combining activity-based therapy with transcutaneous spinal cord stimulation to enhance recovery of arm and hand movements after a cervical spinal cord injury.

How Is the Trial Designed?

Group I: ABT-TCSCS Experimental Treatment 1 Intervention

The participants will receive activity-based therapy combined with transcutaneous spinal cord stimulation.

Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Spinal Cord Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery

Approved in European Union as Transcutaneous Electrical Spinal Cord Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Pain management

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Ontario Neurotrauma Foundation

Collaborator

Trials

24

Recruited

1,100+

Published Research Related to This Trial

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) 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 enhance the excitability of spinal neural circuits, which may improve voluntary performance in patients with incomplete spinal cord injuries (iSCI).

Combining TSCS with therapeutic interventions has the potential to accelerate recovery outcomes, although there is currently a gap in applying this knowledge to clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and Feasibility of Transcutaneous Spinal Cord Stimulation for Patients With Incomplete SCI in Therapeutic Settings: A Review of Topic. Martin, R.[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]

In a study involving 15 participants with chronic spinal cord injury, a 2-hour session of activity-based therapy (ABT) did not lead to acute changes in brain-derived neurotrophic factor (BDNF) levels, which are important for neuroplasticity.

However, the therapy did result in a significant reduction in prolactin levels, suggesting that ABT may influence other neurobiological pathways, although further research is needed to explore the effects of different intensities or modalities on BDNF levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Change in neuroplasticity-related proteins in response to acute activity-based therapy in persons with spinal cord injury. Harness, ET., Astorino, TA., Knoblach, SM., et al.[2018]

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]

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]

In a study of 25 patients (average age 61) who underwent an open paddle lead trial for spinal cord stimulation, 92% had a positive response and proceeded to permanent implantation, indicating high efficacy for this method in patients who cannot undergo percutaneous trials.

The majority of patients (88%) had failed back surgery syndrome, highlighting that open paddle trials can be a crucial option for those with complex cases and extensive scar tissue, ensuring they receive appropriate pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open Paddle Lead Trial for Spinal Cord Stimulation: An Institutional Experience. Akbik, OS., Aoun, SG., Adogwa, O., et al.[2022]

In a study of 19 patients using spinal cord stimulation (SCS) for chronic pain, 74% preferred stimulation settings that produced sensations (above sensory threshold) over those that did not (below threshold), indicating a strong preference for the former in improving quality of life.

Patients using above threshold stimulation showed significant improvements in depression scores after three months, although they reported worse sleepiness, suggesting that while effective for pain management, this setting may impact sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. Owusu, S., Huynh, A., Gruenthal, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06472986

Activity-Based Therapy and Transcutaneous Spinal Cord ... The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand ...

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. researchprotocols.org researchprotocols.org/2025/1/e80995

Effectiveness of Transcutaneous Spinal Cord Stimulation ... Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...

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

Transcutaneous Electrical Spinal Cord Stimulation to ... To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

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

Feasibility and utility of transcutaneous spinal cord ... The purpose of this study was to assess the feasibility and collect preliminary data on the efficacy of providing TSCS with a clinically ...