Spinal Cord Stimulation + Arm Bike for Spinal Cord Injury

Overseen By Katie Singsank

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must not be taking: Antidepressants, Baclofen

Disqualifiers: Autoimmune, Neurologic, Neuropathy, Rheumatic, others

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

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of arm-crank exercise and non-invasive spinal cord stimulation to help individuals with spinal cord injuries improve heart and blood pressure regulation. Researchers aim to determine if this approach can enhance cardiovascular health in those with spinal cord injuries at or above the middle of the back. Participants will receive either real spinal stimulation or a "sham" version during exercise to compare effects. Individuals who have had a spinal cord injury for over a year and experience motor-complete paralysis (complete loss of muscle function) at or above the middle back might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could improve cardiovascular health for those with spinal cord injuries.

Will I have to stop taking my current medications?

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 investigators believe is not in your best interest for the study, it may affect your participation.

What prior data suggests that this combinatory therapy of tSCS and arm-crank exercise is safe for cardiovascular recovery in individuals with SCI?

Research shows that transcutaneous spinal cord stimulation (tSCS), which stimulates the spinal cord through the skin, is generally well-tolerated. Studies have found that people using tSCS for spinal cord injuries usually experience mild side effects, such as skin tingling or slight discomfort at the stimulation site. Previous studies have reported no major safety concerns.

tSCS is often combined with exercise, like using an arm-crank bike, to improve heart and blood vessel health. Trials have tested this combination without serious problems. The exercise resembles using a stationary bike, but for the arms, and is considered safe for most people.

For those considering joining a clinical trial involving tSCS and arm-crank exercise, current evidence suggests the treatment is safe and well-tolerated. Always discuss any concerns with the trial team or a healthcare provider to ensure it's suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation paired with arm-crank exercise because it introduces a novel approach to managing spinal cord injuries. Unlike traditional treatments, which often focus on surgery or medications, this method uses non-invasive electrical stimulation of the spinal cord combined with cardiovascular exercise to potentially improve motor function and cardiovascular health. Additionally, the trial includes a sham stimulation group to better understand the true effects of the stimulation. This could lead to a deeper understanding of how these treatments can enhance recovery and quality of life for those with spinal cord injuries.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Research shows that transcutaneous spinal cord stimulation (tSCS) combined with arm-crank bike exercise may aid recovery from spinal cord injuries. In this trial, one group of participants will receive tSCS paired with arm-crank exercise. Studies have found that tSCS can enhance movement and support heart health. In some studies, participants who combined tSCS with exercise experienced improvements after many sessions, indicating the benefits of repeated sessions. This method stimulates the spinal cord through the skin, potentially helping control automatic body functions like blood pressure and heart rate. This makes it a promising approach for improving heart health in those with spinal cord injuries. ^{6 7 8 9 10}

Who Is on the Research Team?

Soshi Samejima, DPT, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

Adults aged 21-65 with chronic motor-complete spinal cord injury at or above T6, who are medically stable and cleared for arm bike exercise. Participants must understand English (or have an interpreter), be free of certain health issues like unhealed fractures or infections, and not have cardiopulmonary diseases that would make intense training unsafe.

Inclusion Criteria

My spinal cord related issues are currently stable.

Women of childbearing potential must agree to use adequate contraception

Must provide informed consent

Exclusion Criteria

I have had surgery to implant an electrode.

I take more than 40 mg of Baclofen daily.

Are ventilator dependent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either transcutaneous spinal cord stimulation or sham stimulation while exercising on an arm-crank bicycle

8 weeks

3 visits per week (in-person)

Extended Treatment

Participants continue with targeted tSCS paired with arm-crank exercise to evaluate dosage-response

8 weeks

3 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Arm-crank bike exercise
• Transcutaneous Spinal Cord Stimulation

Trial Overview The trial is testing if transcutaneous spinal cord stimulation (tSCS) combined with moderate arm-crank exercise improves cardiovascular function in those with SCI compared to sham stimulation plus exercise. It involves up to 60 visits over six months for exercises and assessments.

How Is the Trial Designed?

Group I: tSCS paired with arm-crank exercise Experimental Treatment 2 Interventions

Device: Transcutaneous Spinal Stimulation Non-invasive electrical stimulation of the spinal cord over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.

Group II: Sham stimulation paired with arm-crank exercise Placebo Group 3 Interventions

Device: Sham Stimulation Non-invasive electrical stimulation of a lower extremity muscle group over the skin. Other: Arm-crank exercise Exercise using an arm-bike to target cardiovascular functioning.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Published Research Related to This Trial

In a study of 98 men with long-standing spinal cord injuries, it was found that cardiovascular responses during exercise were significantly affected by the level of the spinal cord injury, with higher lesions leading to lower physical work capacity and blood pressure responses.

Patients with lower thoracic and lumbar spinal cord injuries showed exercise responses similar to those of able-bodied individuals, highlighting the importance of ergometry for evaluating and prescribing exercise for health maintenance in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arm crank ergometry in chronic spinal cord injured patients. Drory, Y., Ohry, A., Brooks, ME., et al.[2022]

In a study of 28 spinal cord injured individuals, 95% of those who regularly used electrical stimulation bicycle ergometry at home reported benefits such as increased muscle bulk and endurance, while most nonusers stopped exercising within a month after clinic discharge.

Adherence to the home exercise program was influenced by the subject's sex and their exercise habits before injury, highlighting the importance of personal factors in the effectiveness of electrical stimulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term use of computerized bicycle ergometry for spinal cord injured subjects. Sipski, ML., Alexander, CJ., Harris, M.[2006]

The use of implanted pulse generators for functional electrical stimulation (FES) in individuals with complete spinal cord injuries led to significant improvements in muscle strength, endurance, and cycling power, contributing to a gold medal win at the 2016 Cybathlon.

The success of this training and competition has prompted further exploration of FES overground cycling as a valuable rehabilitation tool for enhancing mobility and community engagement in people with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cycle Training Using Implanted Neural Prostheses: Team Cleveland. McDaniel, J., Lombardo, LM., Foglyano, KM., et al.[2020]

Epidural spinal cord stimulation (eSCS) combined with cycling therapy was found to be safe and well-tolerated in seven participants with complete chronic spinal cord injury, with no adverse events reported, even in individuals up to 58 years old and 17 years post-injury.

All participants were able to achieve active cycling without motor assistance when combining eSCS with conscious effort, indicating that this approach can effectively restore volitional movement and improve motor function in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. Hoover, C., Schuerger, W., Balser, D., et al.[2023]

In a study involving 23 individuals with chronic spinal cord injury, a fitness program using arm crank ergometry did not lead to increased shoulder pain compared to a diet-only group, indicating that this exercise may be safe for this population.

While the arm crank ergometry group reported lower shoulder pain scores on the Wheelchair User's Shoulder Pain Index, the differences were not statistically significant, suggesting that further research is needed to determine clinically meaningful changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arm crank ergometry and shoulder pain in persons with spinal cord injury. Dyson-Hudson, TA., Sisto, SA., Bond, Q., et al.[2007]

Arm cycle ergometry training for five weeks significantly improved maximal oxygen consumption by 60.54% in four male subjects with spinal cord injuries, indicating enhanced aerobic capacity.

While there were also increases in maximal work loads (64.32%), only the improvement in oxygen consumption was statistically significant, likely due to the small sample size and variability among subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of arm ergometry training on physical work capacity of individuals with spinal cord injuries. DiCarlo, SE., Supp, MD., Taylor, HC.[2019]

A single session of arm cycling significantly increased corticospinal excitability in the erector spinae muscles for both individuals with spinal cord injury (SCI) and able-bodied controls, indicating a preserved neural response to exercise.

A 6-week home-based arm cycling training program improved trunk function and muscle activity in individuals with incomplete SCI, demonstrating its feasibility and effectiveness for enhancing motor control and movement in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based arm cycling exercise improves trunk control in persons with incomplete spinal cord injury: an observational study. van Helden, JFL., Alexander, E., Cabral, HV., et al.[2023]

A 6-week training program using ergometers for 21 subjects with spinal cord injury showed that workload increased initially but plateaued by week 4, indicating a need for program adjustment after this period.

The study found no signs of overtraining in hematologic or hormonal parameters, confirming that the strengthening and aerobic rehabilitation program is safe for patients in the postacute phase of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise prescription in subjects with spinal cord injuries. Bizzarini, E., Saccavini, M., Lipanje, F., et al.[2016]

The six-minute arm test (6-MAT) was designed for individuals with spinal cord injury and demonstrated excellent test-retest reliability for measuring oxygen consumption and heart rate, indicating it can be a consistent tool for assessing physical performance.

The 6-MAT showed strong concurrent validity with peak oxygen consumption (VO2peak), with a high correlation (r=0.92), suggesting it effectively reflects the aerobic capacity of individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity of the six-minute arm test for the evaluation of cardiovascular fitness in people with spinal cord injury. Hol, AT., Eng, JJ., Miller, WC., et al.[2018]

Computerized electrical stimulation allows individuals with spinal cord injuries to perform cycle ergometry, which provides greater cardiovascular benefits than upper body training alone.

Regular electrically stimulated training leads to improvements in maximal oxygen consumption, glucose uptake, muscle mass, and bone mineral content in the lower extremities, making it a recommended option for motivated patients despite being time-consuming.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electric stimulation in muscle training of the lower extremities in persons with spinal cord injuries]. Mohr, T.[2006]

In a study involving nine male participants with spinal cord injuries, combined arm and leg exercise (HYBRID) resulted in significantly higher oxygen uptake (V˙O2peak) and cardiovascular responses compared to arm cycling alone (ACE) and FES-assisted leg cycling (FES-LCE).

FES-LCE alone produced lower oxygen uptake and cardiovascular metrics, indicating it may not be sufficient for improving aerobic fitness in individuals with spinal cord injuries, suggesting that incorporating combined exercises could enhance fitness outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise responses during functional electrical stimulation cycling in individuals with spinal cord injury. Hasnan, N., Ektas, N., Tanhoffer, AI., et al.[2013]

Citations

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

UCSF Spinal Cord Injury Trial → Transcutaneous Electrical ... The goal of this study is to test whether electrical stimulation from the skin surface starting 3 days after spinal cord injury (SCI) is ...

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 ...

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Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

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Transcutaneous Spinal Stimulation and Exercise for ... Growing evidence indicates that electrical spinal cord stimulation improves motor functions both immediately and over the long term via modulating the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11751795/

Short- and long-term effects of transcutaneous spinal cord ... This study aims to explore the efficacy of acute TSCS for restoring autonomic function at rest and during arm-crank exercise to exhaustion.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06313515

NCT06313515 | Transcutaneous Spinal Cord Stimulation ... The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation ...

8. withpower.com withpower.com/trial/phase-spinal-cord-injuries-3-2024-b3813

Spinal Cord Stimulation + Arm Bike for Spinal Cord Injury The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation ...

9. isrctn.com isrctn.com/ISRCTN17856698

Exercise responses with transcutaneous spinal cord ... This study is investigating the effects of a non-invasive form of spinal cord stimulation (called transcutaneous, meaning across the skin surface) on ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39819908/

Short- and long-term effects of transcutaneous spinal cord ... This study aims to explore the efficacy of acute TSCS for restoring autonomic function at rest and during arm-crank exercise to exhaustion.