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

Trial Summary

What is the purpose of this trial?

The ABT-TCSCS study investigates how feasible and beneficial are activity-based therapy and transcutaneous spinal cord stimulation on improving of arm and hand recovery after cervical spinal cord injury.

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 data supports the idea that Therapy + Stimulation for Spinal Cord Injury is an effective treatment?

The available research shows that Therapy + Stimulation for Spinal Cord Injury can improve movement and function in people with spinal cord injuries. One study found that using electrical stimulation on the spine can help people with chronic spinal cord injuries move their arms and legs better. Another study highlighted that this treatment can make the spinal cord more responsive, which helps people with incomplete injuries perform better voluntarily. Overall, these studies suggest that combining therapy with electrical stimulation can speed up recovery and improve outcomes for those with spinal cord injuries. ^{1 2 3 4 5}

What safety data is available for Therapy + Stimulation for Spinal Cord Injury?

The safety data for Therapy + Stimulation for Spinal Cord Injury, which includes methods like Transcutaneous Spinal Cord Stimulation (tSCS) and Activity-Based Therapy (ABT), can be inferred from various studies. The methodological review of tSCS indicates that it is a non-invasive technique used to stimulate spinal circuitries and facilitate motor responses in individuals with spinal cord injury. While the review focuses on methodology, it implies a level of safety in its non-invasive nature. Additionally, studies on ABT suggest it is aimed at regaining motor and sensory function through repetitive training, which is generally considered safe. However, specific safety outcomes are not detailed in the abstracts provided. ^{1 4 5 6 7}

Is the treatment Activity-Based Therapy and Transcutaneous Spinal Cord Stimulation promising for spinal cord injury?

Yes, the treatment is promising. Research shows that combining Activity-Based Therapy with Transcutaneous Spinal Cord Stimulation can improve movement and strength in people with spinal cord injuries. It helps activate muscles and improve upper and lower limb function, which can significantly enhance the quality of life for those affected. ^{1 3 5 8 9}

Research Team

Sukhvinder Kalsi-Ryan

Principal Investigator

Toronto Rehabilitation Institute

Eligibility Criteria

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

I am over 18 years old.

It has been over 6 months since my spinal cord injury.

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

Exclusion Criteria

I have a problem with my arm or hand.

I am unable to understand or sign the consent form.

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

2. Switzerland 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. [2022]

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

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

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

Change in neuroplasticity-related proteins in response to acute activity-based therapy in persons with spinal cord injury. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Open Paddle Lead Trial for Spinal Cord Stimulation: An Institutional Experience. [2022]

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

Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. [2022]

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

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

9. 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]