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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help individuals with high-level spinal cord injuries (SCI) improve their breathing during exercise. It tests two methods: a breathing support machine (non-invasive ventilation or NIV) and a medication called Buspar (Buspirone, an anti-anxiety medication). Participants will engage in a six-month rowing exercise program with various combinations of these treatments to determine the most effective approach. This trial targets wheelchair users with spinal cord injuries above the middle back who can follow directions and have leg muscles responsive to stimulation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Functional Electrical Stimulation Row Training (FESRT) is generally safe for people with spinal cord injuries. Studies indicate it can improve heart health without causing serious side effects. Participants experienced benefits such as lower blood sugar and better body composition.

Early findings suggest that the combination of Non-Invasive Ventilation (NIV) and Buspirone is well-tolerated. Non-invasive ventilation aids breathing in spinal cord injury patients and may reduce the risk of pneumonia. Buspirone has shown promise in improving breathing problems related to spinal cord injuries and may help reduce certain types of sleep apnea.

This study is in Phase 2, meaning researchers have previously studied the safety of these treatments but are now examining them further. Monitoring individual responses to these treatments is important, but they appear to be safe options for managing challenges related to spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a novel approach to treating spinal cord injuries using Functional Electrical Stimulation Row Training (FESRT) combined with different breathing support and medication strategies. Unlike traditional therapies that primarily focus on physical rehabilitation alone, this trial investigates how adding non-invasive ventilation (NIV) and the medication Buspirone (Buspar) might enhance recovery. The unique combination of electrical stimulation and respiratory support aims to improve muscle function and breathing capacity, potentially offering a more comprehensive recovery pathway. This innovative method could lead to more effective interventions for spinal cord injury patients, improving their quality of life significantly.

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

Research has shown that Functional Electrical Stimulation Row Training (FESRT) can boost heart health and help prevent bone loss in people with spinal cord injuries. This exercise involves moving the arms while electrical pulses stimulate the leg muscles, potentially improving exercise capacity. In this trial, participants will undergo FESRT combined with different interventions. Some will receive Non-Invasive Ventilation (NIV), which studies have indicated can help with breathing problems in people with severe spinal cord injuries, reducing the risk of pneumonia. Others will take Buspirone, a drug that has been found to support the recovery of movement and improve control after spinal cord injuries. By combining these treatments in various arms, the trial aims to enhance breathing and overall fitness in people with spinal cord injuries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7924001/

Buspirone Dose-Response on Facilitating Forelimb ... Our results demonstrate a significant dose-dependence of Buspirone on the recovery of forelimb motor functions after cervical cord injury.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33495579/

Buspirone for functional improvement after acute traumatic ... Buspirone group individuals with initial clinically complete SCI demonstrated a higher 1-year conversion rate to incomplete injury (6 out of 14; 42.9%)

3. nature.com nature.com/articles/s41598-018-33123-5

Engaging cervical spinal circuitry with non-invasive ... We conclude that the serotonin agonist Buspirone and electrical stimulation of the cervical cord can improve the strength and voluntary control ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0753332224015737

Acute effects of L-DOPA/carbidopa/buspirone (Spinalon™) ... Even though serotonergic agents can improve the recovery of motor function following a spinal cord injury in animal models [44], [45], [46], buspirone, a 5-HT1A ...

5. frontiersin.org frontiersin.org/journals/cellular-neuroscience/articles/10.3389/fncel.2019.00573/full

Biphasic Effect of Buspirone on the H-Reflex in Acute ... Buspirone, a partial serotonin receptor agonist (5-HT1A), was recently shown to facilitate and even trigger locomotor movements in mice after complete spinal ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12161830/

Functional electric stimulation-assisted rowing Objectives: To assess changes in peak functional aerobic power after a 36-session, progressive functional electric stimulation (FES) rowing hybrid training ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02602639

Functional Electrical Stimulation With Rowing as Exercise ... Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4519233/

Functional Electrical Stimulation and Spinal Cord Injury - PMC Early functional results indicate that subjects can use the system to perform a variety of activities of daily living (ADL) in the home. Implanted FES systems ...

9. nature.com nature.com/articles/sc201476

A six-week motor-driven functional electronic stimulation ... Reduced plasma glucose and leptin after 12 weeks of functional electrical stimulation-rowing exercise training in spinal cord injury patients.

10. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999302000321

Functional electric stimulation–assisted rowing We asked 3 questions: (1) Is FES rowing effective in improving cardiovascular fitness of people with spinal cord damage?; (2) Is FES rowing a safe training ...