Functional Electrical Stimulation + Respiratory Muscle Training for Spinal Cord Injury

(AFES and RMT Trial)

Overseen By Stephane Philippe-Ratway, MS, CCC-SLP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Traumatic brain injury, Pacemakers, Epilepsy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2-4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help people with spinal cord injuries improve their ability to cough independently. The study combines electrical stimulation, which uses small electrical pulses to activate muscles, with training to strengthen breathing muscles. The Xcite Clinical Station delivers the electrical stimulation. There are two treatment groups: one for individuals with paraplegia (paralysis of the lower half of the body) and another for those with tetraplegia (paralysis of all four limbs). Individuals who have had a spinal cord injury for less than a year and can feel muscle contractions from electrical stimulation might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative treatments for spinal cord injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Xcite Clinical Station is safe for individuals with spinal cord injuries?

Research shows that the Xcite Clinical Station, used for abdominal and breathing muscle exercises, is generally safe and well-tolerated. The Xcite system meets important safety standards, ensuring it operates without causing electric shocks or interfering with other devices.

Studies on similar technologies, such as the RISES system for spinal stimulation, have found them safe and practical, with no major side effects reported. Although detailed information on side effects specific to this treatment is limited, the devices' compliance with recognized safety standards offers some reassurance about their safety in humans.

Overall, despite some unknowns, current evidence suggests that the treatment is expected to be safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of Functional Electrical Stimulation (FES) and Respiratory Muscle Training (RMT) for spinal cord injury because this approach offers a novel way to enhance muscle function and breathing capacity. Unlike standard treatments that often focus on rehabilitation through physical therapy alone, this method uses electrical impulses to directly stimulate abdominal muscles, potentially improving muscle strength and respiratory function more effectively. By integrating these two techniques, the treatment could provide quicker and more substantial improvements in both paraplegia and tetraplegia patients, offering new hope for enhanced recovery and quality of life.

What evidence suggests that the Xcite Clinical Station is effective for improving cough in spinal cord injury?

Research has shown that using Functional Electrical Stimulation (FES) with Respiratory Muscle Training (RMT) can improve breathing in people with spinal cord injuries. In this trial, participants will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT). Studies have found that FES strengthens muscles and improves their function, even after nerve damage. The Xcite Clinical Station uses this method and has shown promise in helping patients regain muscle function by focusing on specific tasks. Early results suggest that this combined therapy may enhance cough strength, which is crucial for clearing airways in people with spinal cord injuries. Overall, evidence supports this approach, showing better outcomes for similar conditions. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephane Philippe-Ratway, MS, CCC-SLP

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with acute spinal cord injuries (C2-T12 level, AIS A-C) who are in rehab and were injured less than a year ago. They must respond to electrical stimulation and speak English. It's not for those with severe brain injury, open tracheostomy, pacemakers, pregnancy, epilepsy, wounds or metal at the electrode site, unresponsiveness to electrical stimulation or history of certain cancers.

Inclusion Criteria

My muscles respond to electrical stimulation with a visible contraction.

I am fluent in both written and spoken English.

I have a spinal cord injury between C2-T12 and am in rehab for it.

Exclusion Criteria

Pregnant women

Individuals who do not meet inclusion criteria

You have a tracheostomy that is still open.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT)

2-4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Xcite Clinical Station

Trial Overview The study tests if using the Xcite Clinical Station—electrical stimulation on abdominal and latissimus dorsi muscles combined with respiratory muscle training—can improve coughing ability in people with recent spinal cord injuries.

How Is the Trial Designed?

Group I: AFES and RMT Tetraplegia Group Experimental Treatment 1 Intervention

Patients with a diagnosis of tetraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 4 weeks.

Group II: AFES and RMT Paraplegia Group Experimental Treatment 1 Intervention

Patients with a diagnosis of paraplegia will receive co-treatment with abdominal functional electrical stimulation (AFES) and respiratory muscle training (RMT) for 2 weeks.

Xcite Clinical Station is already approved in United States, European Union for the following indications:

Approved in United States as Xcite FES Clinical Station for:

• Muscle weakness
• Muscle atrophy
• Neurological impairments
• Spinal cord injuries

Approved in European Union as Xcite iFES Clinical Station for:

• Muscle weakness
• Muscle atrophy
• Neurological impairments
• Spinal cord injuries

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Published Research Related to This Trial

A three-week program of passive abdominal functional electrical stimulation (AFES) significantly increased forced vital capacity (FVC) by 0.36 liters in 12 patients with tetraplegia, indicating improved respiratory function during training.

The study suggests that AFES can be an effective method for respiratory rehabilitation in individuals with tetraplegia, as no significant changes were observed before or after the training period, highlighting the training's specific impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in pulmonary function measures following a passive abdominal functional electrical stimulation training program. McLachlan, AJ., McLean, AN., Allan, DB., et al.[2021]

Functional magnetic stimulation (FMS) significantly improved expiratory muscle strength in eight men with tetraplegia after a 4-week training period, with increases in key measures such as maximal expired pressure and expiratory reserve volume.

The improvements in muscle strength were temporary, as the benefits diminished after a 2-week discontinuation of FMS, suggesting that ongoing treatment may be necessary to maintain the gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional magnetic stimulation for conditioning of expiratory muscles in patients with spinal cord injury. Lin, VW., Hsiao, IN., Zhu, E., et al.[2022]

Functional electrical stimulation (FES) significantly improved cardiovascular fitness, as indicated by increased tidal volume and oxygen consumption during exercise phases, with results showing p-values less than .001.

FES also led to significant increases in thigh girth, suggesting improvements in muscle mass, while demonstrating safety with no serious complications reported, making it an effective intervention for individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electric stimulation: its efficacy and safety in improving pulmonary function and musculoskeletal fitness. Arnold, PB., McVey, PP., Farrell, WJ., et al.[2004]

A 16-week program of FES-assisted walking significantly improved mobility in individuals with chronic incomplete spinal cord injury compared to a non-FES exercise program, as shown by the increase in the SCIM mobility sub-score.

Both groups showed improvements in walking speed, endurance, and balance, indicating that task-oriented training is beneficial for enhancing walking ability, even in chronic stages of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. Kapadia, N., Masani, K., Catharine Craven, B., et al.[2021]

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]

In a study involving 35 participants with motor-incomplete spinal cord injury, daily use of functional electrical stimulation (FES) over six months led to significant improvements in walking speed, indicating a potential training effect.

The results showed a clinically meaningful change in walking speed both with and without FES, suggesting that FES can enhance rehabilitation outcomes for individuals with drop foot and motor-incomplete SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinically meaningful training effect in walking speed using functional electrical stimulation for motor-incomplete spinal cord injury. Street, T., Singleton, C.[2019]

Abdominal Functional Electrical Stimulation (AFES) was found to be a feasible intervention for improving respiratory function in 10 acute ventilator-dependent tetraplegic patients, with a high compliance rate of 96.7%.

Participants using AFES showed significant increases in tidal volume and vital capacity, and they were able to wean off mechanical ventilation an average of 11 days faster than matched controls, suggesting AFES may enhance recovery in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abdominal Functional Electrical Stimulation to Assist Ventilator Weaning in Acute Tetraplegia: A Cohort Study. McCaughey, EJ., Berry, HR., McLean, AN., et al.[2018]

All 50 spinal cord injury patients with lesions from T4-T12 were able to stand using functional electrical stimulation (FES), demonstrating its efficacy in restoring standing ability.

Out of the 50 patients, 25 were able to walk with FES, but after three months of home use, only 16 continued to walk due to challenges in adapting to the FES system and its operational demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of gait restoration in spinal injured patients by functional electrical stimulation. Kralj, A., Bajd, T., Turk, R.[2006]

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]

The study involving 19 spinal cord injured individuals demonstrated that computerized functional electrical stimulation (FES) is safe and effective in increasing quadriceps strength and endurance after a training program.

Participants showed improved endurance on a lower extremity ergometer, indicating a potential training effect, as they were able to perform more work at similar heart rates and blood pressure levels, although further research is needed to fully understand the cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. Ragnarsson, KT., Pollack, S., O'Daniel, W., et al.[2004]

In a study of 14 volunteers with spinal cord injuries, 57% were responsive to Neuromuscular Electrical Stimulation (NMES), indicating that FES-Cycling could be a beneficial option for those with paraplegia.

The study found that individuals with traumatic spinal cord injuries above the T12 vertebral level were more likely to respond positively to NMES, suggesting they are the best candidates for FES-Cycling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Parameters and Protocols to Recommend FES-Cycling in Cases of Paraplegia: A Preliminary Report. Guimarães, JA., da Fonseca, LO., Dos Santos-Couto-Paz, CC., et al.[2020]

A study involving 30 subjects with spinal cord injury demonstrated that functional electrical stimulation (FES) exercise programs safely improved lower extremity muscle strength, endurance, and bulk.

Participants showed enhanced aerobic metabolism and increased muscle density, indicating that FES can effectively reverse some degenerative changes associated with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiologic effects of functional electrical stimulation-induced exercises in spinal cord-injured individuals. Ragnarsson, KT.[2007]

Functional electrical stimulation leg cycle ergometer (FES-LCE) training over 12 weeks significantly improved strength and endurance in paralyzed muscles of spinal cord injured (SCI) subjects, as indicated by increased power output during exercise.

The training led to improved cardiovascular responses, such as increased stroke volume and cardiac output during submaximal exercise, and more stable heart rate and blood pressure in quadriplegics, which may enhance rehabilitation outcomes and reduce risks of cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation leg cycle ergometer exercise: training effects on cardiorespiratory responses of spinal cord injured subjects at rest and during submaximal exercise. Faghri, PD., Glaser, RM., Figoni, SF.[2006]

Citations

1. withpower.com withpower.com/trial/phase-spinal-cord-injuries-3-2023-ab5ac

Functional Electrical Stimulation + Respiratory Muscle ... The Xcite Clinical Station treatment is unique because it combines Functional Electrical Stimulation (FES) with Respiratory Muscle Training, which can help ...

2. journals.sagepub.com journals.sagepub.com/doi/10.1177/20556683241280242

An innovative and activity-based closed-loop framework for ... The RISES system utilizes the FDA-cleared Xcite system for stimulation delivery. The system provides No-Burst stimulation options as part of its ...

3. restorative-therapies.com restorative-therapies.com/xcite2/

Xcite2 Xcite2 was designed to allow clinicians to easily and efficiently apply multi-channel integrated FES with task-specific activities commonly completed in therapy ...

4. restorative-therapies.com restorative-therapies.com/2025/04/18/elevating-neurorehabilitation-with-task-specific-fes-how-the-xcite2-therapy-system-transforms-clinical-practice/

Elevating Neurorehabilitation with Task-Specific FES Xcite2 delivers task-specific functional electrical stimulation (FES) that supports neurological recovery from stroke, SCI, brain injury, and more.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9936196/

Electrical stimulation for the treatment of spinal cord injuries Epidural electrical stimulation, peripheral nerve stimulation, and functional electrical stimulation have shown promising improvements for individuals with SCI.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11483808/

Initial feasibility evaluation of the RISES system: An innovative ... This study piloted the safety and feasibility of the Reynolds Innovative Spinal Electrical Stimulation (RISES) technology with a focus on its novel closed-loop ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K160614.pdf

K160614 Trade/Device Name: Xcite Cli - accessdata.fda.gov The system complies with Electromagnetic Compatibility and Electrical Safety. The Xcite system conforms to the following standards; IEC60601-1, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03621254

Investigation Into Optimal FES Training Characteristics ... The aim of this study is to investigate two different modalities of functional electrical stimulation (FES) leg exercise in patients with spinal cord injury ( ...