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

Trial Summary

What is the purpose of this trial?

Spinal cord injury (SCI) can make it hard for the body to self-regulate some of its automatic functions like blood pressure, breathing, and heart rate. This can also make it hard for those living with SCI to exercise or complete their usual daily activities. The goal of this randomized trial is to test combinatory therapy of moderate arm-crank exercise paired with non-invasive transcutaneous spinal cord stimulation (tSCS) for cardiovascular recovery in adults aged 21-65 following chronic motor-complete spinal cord injury (SCI) at or above the thoracic sixth spinal segment (≥T6). The main questions the study aims to answer are: * Conduct tSCS mapping to determine the most effective location and stimulation intensity for BP control in individuals with motor-complete SCI ≥ T6. * Evaluate the effects 8 weeks of targeted tSCS paired with arm-crank exercise compared to sham stimulation with exercise on improving cardiovascular function in individuals with motor-complete SCI ≥T6. * Evaluate the dosage-response of 8 weeks vs. 16 weeks of targeted tSCS paired with arm-crank exercise on cardiovascular function in individuals with motor-complete SCI ≥T6. * Explore the mechanisms involved in cardiovascular recovery with long-term tSCS paired with arm-crank exercise. Participants will: * Receive either transcutaneous spinal cord stimulation or "sham" spinal cord stimulation while exercising on an arm-crank bicycle in the first 8 weeks. * Come in for approximately 60 visits over a 6-month period. This includes 2, 8-week periods where the investigators will ask participants to come in 3x per week for spinal cord stimulation and exercise. * During assessment visits the researchers will perform a variety of exams including a neurologic, cardiovascular, pulmonary, physical, and autonomic exam, and will ask questions about quality of life and functioning. Researchers will compare those who receive tSCS and do moderate arm-crank exercise to those who receive a sham stimulation and do moderate arm-crank exercise to see if tSCS is effective at improving cardiovascular and autonomic functioning in those with SCI.

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 data supports the effectiveness of the treatment Spinal Cord Stimulation + Arm Bike for Spinal Cord Injury?

Research shows that arm cycle ergometry, a component of this treatment, can significantly improve physical work capacity in individuals with spinal cord injuries, as evidenced by increased oxygen consumption and work loads. Additionally, electrical stimulation cycling has been associated with increased muscle bulk, endurance, and cardiovascular benefits, suggesting potential effectiveness for rehabilitation in spinal cord injury patients. ^{1 2 3 4 5}

Is Spinal Cord Stimulation combined with Arm Bike exercise safe for humans?

Research indicates that arm crank ergometry and spinal cord stimulation, when used separately, are generally safe for individuals with spinal cord injuries. Studies have shown that these activities are well-tolerated, with no adverse events reported, making them a potentially safe option for physical therapy. ^{5 6 7 8 9}

How does the treatment of spinal cord stimulation combined with arm-crank bike exercise differ from other treatments for spinal cord injury?

This treatment is unique because it combines spinal cord stimulation with arm-crank bike exercise, which is a low-risk, low-weight-bearing activity that can help improve motor function and trunk control in individuals with spinal cord injury. Unlike other treatments, this approach leverages the benefits of neuromodulation and physical activity to enhance voluntary movement and is safe for patients who may be at high risk of injury with weight-bearing exercises. ^{2 5 8 10 11}

Research Team

Soshi Samejima, DPT, PhD

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Effect of arm ergometry training on physical work capacity of individuals with spinal cord injuries. [2019]

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

Exercise responses during functional electrical stimulation cycling in individuals with spinal cord injury. [2013]

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

Long-term use of computerized bicycle ergometry for spinal cord injured subjects. [2006]

4. Italy pubmed.ncbi.nlm.nih.gov

Cycle Training Using Implanted Neural Prostheses: Team Cleveland. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

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

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

Arm crank ergometry and shoulder pain in persons with spinal cord injury. [2007]

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

Arm crank ergometry in chronic spinal cord injured patients. [2022]

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

Neuromodulation Through Spinal Cord Stimulation Restores Ability to Voluntarily Cycle After Motor Complete Paraplegia. [2023]

9. United States 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. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Home-based arm cycling exercise improves trunk control in persons with incomplete spinal cord injury: an observational study. [2023]

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

Exercise prescription in subjects with spinal cord injuries. [2016]