FES Exercise + NIV/Buspirone for Spinal Cord Injury

Overseen By Glen Picard, MA

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Spaulding Rehabilitation Hospital

Must not be taking: Cardioactive, Buspirone, MAO inhibitors, others

Disqualifiers: Hypertension, Diabetes, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. However, despite the potential for enhancing aerobic capacity by training the denervated leg skeletal muscle via hybrid FES exercise, the inability to increase ventilation beyond limits set by high level SCI restricts aerobic capacity. This research study will investigate two potential methods of improving ventilation in those with high-level SCI through a double-blind randomized trial. One method is non-invasive ventilation (NIV), which is an external breathing support machine. The second method is the use of Buspar, a drug, which has been used to treat respiratory dysfunction after SCI in rats and some human case reports. In this study, participants will engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo, and under study tests to evaluate cardiopulmonary health and fitness.

Will I have to stop taking my current medications?

The trial requires that you stop taking any cardioactive medications (medications that affect the heart) and buspirone before participating. If you are on these medications, you would need to discontinue them to join the study.

What data supports the effectiveness of this treatment for spinal cord injury?

Research shows that Functional Electrical Stimulation (FES) rowing can improve cardiovascular fitness and allow individuals with spinal cord injuries to participate in high-intensity exercise, similar to able-bodied individuals. This suggests that FES rowing, as part of the treatment, may offer significant health benefits for people with spinal cord injuries. ^{1 2 3 4 5}

Is Functional Electrical Stimulation (FES) safe for people with spinal cord injuries?

Research indicates that Functional Electrical Stimulation (FES) is generally safe for people with spinal cord injuries, even in those with additional conditions like autonomic dysreflexia (a condition causing sudden high blood pressure) and a pacemaker, as long as there is proper monitoring of symptoms and vital signs during exercise. ^{1 3 4 6 7}

How is the FES Exercise + NIV/Buspirone treatment for spinal cord injury different from other treatments?

The FES Exercise + NIV/Buspirone treatment is unique because it combines Functional Electrical Stimulation (FES) with rowing, which allows individuals with spinal cord injuries to engage in high-intensity exercise and even compete in rowing events, potentially improving cardiovascular fitness and reducing shoulder pain. This approach is novel as it enables participation in competitive sports and achieves exercise intensities similar to those beneficial for the general population. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for medically stable adults aged 18-45 with a high-level spinal cord injury (SCI), specifically ASIA Scale A, B, or C at or above T4. Participants should be 3 months to 6 years post-injury, able to follow directions, use a wheelchair and have leg muscles responsive to stimulation. Exclusions include hypertension, tobacco use, epilepsy, other neurological diseases, renal disease, cancer, certain medication usage including buspirone and MAO inhibitors.

Inclusion Criteria

My health condition is currently stable.

My leg muscles respond when touched or stimulated.

You have a body mass index (BMI) between 18.5 and 30, which means you are normal to overweight but not obese.

Exclusion Criteria

I have cancer.

I am currently taking buspirone.

I am currently taking medication for my heart, excluding blood pressure medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month FES row training program while receiving either NIV or shamNIV and Buspar or placebo

24 weeks

Regular visits for training and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Buspirone Hydrochloride
• Functional Electrical Stimulation Row Training (FESRT)
• Non-invasive ventilation (NIV)

Trial Overview The study tests two methods to improve breathing in people with high-level SCI during a 6-month Functional Electrical Stimulation Row Training program: Noninvasive Ventilation (NIV) which is an external breathing support machine; and Buspar (Buspirone Hydrochloride), a drug potentially beneficial for respiratory dysfunction after SCI. Participants will receive either NIV or sham ventilation along with Buspar or placebo.

Participant Groups

Group I: NIV + Buspar Experimental Treatment 3 Interventions

Subjects will perform 6 months of FES-row-training while receiving NIV and taking Buspar.

Group II: sham NIV + placebo Active Control 3 Interventions

Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking placebo.

Group III: sham NIV + Buspar Placebo Group 3 Interventions

Subjects will perform 6 months of FES-row-training while receiving sham NIV and taking Buspar.

Group IV: NIV + placebo Placebo Group 3 Interventions

Subjects will perform 6 months of FES-row-training while receiving NIV and taking placebo.

Functional Electrical Stimulation Row Training (FESRT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Functional Electrical Stimulation for:

• Spinal cord injury rehabilitation
• Muscle strengthening
• Cardiopulmonary health improvement

Approved in European Union as Functional Electrical Stimulation for:

• Spinal cord injury rehabilitation
• Muscle strengthening
• Cardiopulmonary health improvement

Approved in Canada as Functional Electrical Stimulation for:

• Spinal cord injury rehabilitation
• Muscle strengthening
• Cardiopulmonary health improvement

Who Is Running the Clinical Trial?

Spaulding Rehabilitation Hospital

Lead Sponsor

Trials

143

Recruited

11,200+

Findings from Research

A 12-week progressive functional electric stimulation (FES) rowing training program significantly improved peak functional aerobic power in individuals with spinal cord injury, with peak oxygen consumption increasing by 11.2% and rowing distance by 25%.

The ROWSTIM II device was found to be safe and well-accepted by participants, demonstrating that FES-assisted rowing is an effective training method for enhancing aerobic capacity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. Wheeler, GD., Andrews, B., Lederer, R., et al.[2019]

Functional electrical stimulation (FES)-rowing significantly improves cardiovascular performance in individuals with spinal cord injury (SCI), with an average increase in peak oxygen consumption (V̇o2peak) of 11.2% compared to arm-only exercise.

FES-rowing also helps reduce bone density loss over time after injury, making it a beneficial exercise option for rehabilitation in SCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Benefits and System Design of FES-Rowing Exercise for Rehabilitation of Individuals with Spinal Cord Injury: A Systematic Review. Ye, G., Grabke, EP., Pakosh, M., et al.[2021]

The study demonstrated that six individuals with spinal cord injuries successfully used a functional electrical stimulation (FES) rowing system to compete in major indoor rowing events, achieving high exercise intensities and volumes.

Participants reached steady state VO2 values of 2.5 L/min and trained at a volume of 1150 kcal/week, indicating that FES-assisted rowing can provide significant health benefits comparable to those seen in able-bodied individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of functional electrical stimulation indoor rowing for high-energy training and sport. Hettinga, DM., Andrews, BJ.[2022]

Hybrid High-Intensity Interval Training (HIIT) using Functional Electrical Stimulation (FES) was found to be safe and well-accepted by participants with spinal cord injuries, with no serious adverse events reported during the 8-week study involving 8 participants.

Participants experienced a significant 17% increase in peak oxygen uptake (VO2peak) and reported improvements in leisure time physical activity and quality of life, indicating that this training method can enhance physical fitness and overall well-being for individuals with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. Vestergaard, M., Jensen, K., Juul-Kristensen, B.[2022]

A 6-week functional electrical stimulation (FES)-assisted rowing program significantly improved aerobic fitness, with participants showing an 8% increase in VO2 peak and increased distance rowed by an average of 257 meters.

The intervention also led to a notable reduction in shoulder pain, with a decrease of 10.5 points on the Wheelchair User Shoulder Pain Index, indicating that FES-assisted rowing can be an effective method for managing pain in manual wheelchair users with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of functional electrical stimulation assisted rowing on aerobic fitness and shoulder pain in manual wheelchair users with spinal cord injury. Wilbanks, SR., Rogers, R., Pool, S., et al.[2019]

A 36-year-old male with cervical spinal cord injury and a history of autonomic dysreflexia safely participated in a 10-session interval-FES cycling program, demonstrating that such exercise can be beneficial with proper monitoring.

During the sessions, the participant experienced self-limited chills correlated with blood pressure increases, but overall, his heart function remained normal, indicating that FES cycling can be safely integrated into rehabilitation for individuals with similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and preliminary efficacy of functional electrical stimulation cycling in an individual with cervical cord injury, autonomic dysreflexia, and a pacemaker: Case report. Corbin, GN., Weaver, K., Dolbow, DR., et al.[2021]

Functional electrical stimulation cycling (FESC) has provided significant health benefits and improved cycling ability for spinal cord injured persons (SCIPs) over two years of use.

To maximize the benefits of FESC for SCIPs, future research should focus on making the activity more convenient and enjoyable, emphasizing the importance of user experience in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A personal user's view of functional electrical stimulation cycling. Fitzwater, R.[2019]

References

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

Functional electric stimulation-assisted rowing: Increasing cardiovascular fitness through functional electric stimulation rowing training in persons with spinal cord injury. [2019]

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

Clinical Benefits and System Design of FES-Rowing Exercise for Rehabilitation of Individuals with Spinal Cord Injury: A Systematic Review. [2021]

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

The feasibility of functional electrical stimulation indoor rowing for high-energy training and sport. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Hybrid high-intensity interval training using functional electrical stimulation leg cycling and arm ski ergometer for people with spinal cord injuries: a feasibility study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of functional electrical stimulation assisted rowing on aerobic fitness and shoulder pain in manual wheelchair users with spinal cord injury. [2019]

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

Safety and preliminary efficacy of functional electrical stimulation cycling in an individual with cervical cord injury, autonomic dysreflexia, and a pacemaker: Case report. [2021]

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

A personal user's view of functional electrical stimulation cycling. [2019]