Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Fiona E Fox, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: James J. Peters Veterans Affairs Medical Center

Disqualifiers: Seizures, Diabetes, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this interventional crossover study is to determine the effects of transcutaneous spinal cord stimulation (TSCS) on the ability to perform moderate exercise and regulate core body temperature in the chronic spinal cord injury community. The main questions it aims to answer are: * What are the effects of active TSCS targeted for BP control on exercise endurance time and HR recovery during submaximal arm cycle ergometry (ACE) as compared to sham TSCS in participants with chronic, cervical SCI? * What are the effects of active TSCS on Tcore responses to cool ambient exposure and on subjective reporting of thermal comfort and thermal sensitivity as compared to sham TSCS. Participants will receive sham and active stimulation while using an arm bicycle or while in a cold room. Participants are free to participate in either the exercise phase, the cold room phase, or both phases of this study. Please note that there no expected long term benefits of this study.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your prescription medications have not changed for at least 30 days before participating.

What data supports the effectiveness of the treatment Transcutaneous Spinal Cord Stimulation (TSCS) for spinal cord injury?

Research indicates that Transcutaneous Spinal Cord Stimulation (TSCS) can enhance motor function and recovery in individuals with spinal cord injury by stimulating spinal circuits and improving the excitability of neural pathways. This non-invasive treatment has shown promise in improving both upper and lower limb function, making it a valuable tool in rehabilitation settings. ^{1 2 3 4 5}

Is transcutaneous spinal cord stimulation (tSCS) generally safe for humans?

Transcutaneous spinal cord stimulation (tSCS) is considered a non-invasive and generally safe procedure, as it aims to stimulate spinal circuits without surgery. While specific safety data for tSCS in spinal cord injury is limited, spinal cord stimulation in general is regarded as a minor elective procedure with a focus on minimizing potential risks. ^{1 4 6 7 8}

How does spinal cord stimulation differ from other treatments for spinal cord injury?

Spinal cord stimulation is unique because it is a non-invasive treatment that uses electrodes to stimulate the spinal cord, helping to improve motor function and recovery after a spinal cord injury. Unlike other treatments, it can modulate the spinal cord's circuitry without surgery, potentially enhancing rehabilitation outcomes by activating specific spinal segments. ^{1 2 4 5 9}

Research Team

Jill M Wecht, EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

This trial is for adults over 18 with chronic spinal cord injury (SCI) between C3-T6, who have been injured for more than a year and haven't changed their meds in the last month. They should have previously participated in a related SCI study and not be pregnant or suffering from other neurological conditions, heart diseases, severe head trauma, psychological disorders, recent substance abuse, seizures, diabetes or untreated thyroid disease.

Inclusion Criteria

You have taken part in a previous study called 'Targeted Transcutaneous Spinal Cord Stimulation to Restore Autonomic Cardiovascular Health in Individuals with Spinal Cord Injury'.

You have been injured for more than 1 year.

My prescription medications have been the same for the last 30 days.

Exclusion Criteria

I rely on a ventilator for breathing or have an open tracheostomy.

I have had a serious head injury or have been diagnosed with cognitive impairment.

You currently have or have had a mental health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise Phase

Participants receive active and sham TSCS during submaximal arm cycle ergometry to assess exercise endurance and heart rate recovery.

2 visits, 3-4 hours each

2 visits (in-person)

Cold Room Phase

Participants receive active and sham TSCS in a cool environment to assess body temperature regulation and thermal comfort.

2 visits, 3-4 hours each

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Sham Transcutaneous Spinal Cord Stimulation
• Transcutaneous Spinal Cord Stimulation (TSCS)

Trial Overview The study tests if transcutaneous spinal cord stimulation (TSCS) can help people with cervical SCI endure moderate exercise longer and regulate body temperature better compared to sham stimulation. Participants will try both real and fake stimulations while exercising or being exposed to cold temperatures.

Participant Groups

Group I: Transcutaneous Spinal Cord Stimulation Experimental Treatment 1 Intervention

The transcutaneous spinal cord stimulation used in this experiment is specific to each participant as determined in a previous study. Possible parameters include biphasic or monophasic, Russian or Nonrussian, a variety of pulse widths, and location of stimulation (T7-8, T9-10,- T11-12, L1-2). The amplitude of the stimulation also depends on the results of the mapping study. This stimulation will be delivered 30 minutes at a time.

Group II: Sham Transcutaneous Spinal Cord Stimulation Placebo Group 1 Intervention

The sham stimulation will follow the above parameters but will only be delivered for a minute rather than the full 30 minutes.

Who Is Running the Clinical Trial?

James J. Peters Veterans Affairs Medical Center

Lead Sponsor

Trials

59

Recruited

2,900+

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]

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 (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]

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]

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

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 study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

A new animal model for transcutaneous spinal cord stimulation (tSCS) was developed, which accurately mimics human responses and allows for stable, repeated treatments after spinal cord injury (SCI) with minimal restraint.

The study demonstrated that tSCS can effectively modulate motor output in rats after complete spinal cord transection, suggesting its potential for promoting neuroplasticity and functional recovery in SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. Malloy, DC., Knikou, M., Côté, MP.[2023]

References

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

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

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

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

3. 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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Anticipating and preventing complications in spinal cord stimulator implantation. [2023]

7. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adapting Human-Based Transcutaneous Spinal Cord Stimulation to Develop a Clinically Relevant Animal Model. [2023]