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

Trial Summary

What is the purpose of this trial?

The overall objective of this study is to improve unaided cough with abdominal and latissimus dorsi functional electrical stimulation in conjunction with respiratory muscle training in individuals with acute 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 data supports the effectiveness of the treatment Xcite Clinical Station, Xcite FES Clinical Station, Xcite iFES Clinical Station, Xcite2 iFES Clinical Station for spinal cord injury?

Research shows that functional electrical stimulation (FES) can help people with spinal cord injuries improve muscle strength, endurance, and walking ability. In studies, FES has been used to help patients stand and walk, and it has also been shown to increase muscle density and aerobic metabolism, which are important for overall fitness and health. ^{1 2 3 4 5}

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

Research shows that Functional Electrical Stimulation (FES) is generally safe for people with spinal cord injuries. Studies have found improvements in fitness and muscle strength without serious complications. ^{3 6 7 8 9}

How is the Xcite Clinical Station treatment different from other treatments for spinal cord injury?

The Xcite Clinical Station treatment is unique because it combines Functional Electrical Stimulation (FES) with Respiratory Muscle Training, which can help improve both muscle function and respiratory capacity in individuals with spinal cord injury. This dual approach is not commonly found in other treatments, which often focus on either muscle or respiratory function separately. ^{1 10 11 12 13}

Research Team

Stephane Philippe-Ratway, MS, CCC-SLP

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 (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]

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]

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]

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 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]

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]

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]

References

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

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

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

Enhancement of gait restoration in spinal injured patients by functional electrical stimulation. [2006]

3. 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]

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

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

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

Functional magnetic stimulation for conditioning of expiratory muscles in patients with spinal cord injury. [2022]

6. 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]

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

Functional electric stimulation: its efficacy and safety in improving pulmonary function and musculoskeletal fitness. [2004]

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

Clinical evaluation of computerized functional electrical stimulation after spinal cord injury: a multicenter pilot study. [2004]

9. United States 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. [2006]

10. Italy pubmed.ncbi.nlm.nih.gov

Towards Parameters and Protocols to Recommend FES-Cycling in Cases of Paraplegia: A Preliminary Report. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Changes in pulmonary function measures following a passive abdominal functional electrical stimulation training program. [2021]

12. England pubmed.ncbi.nlm.nih.gov

A randomized trial of functional electrical stimulation for walking in incomplete spinal cord injury: Effects on walking competency. [2021]

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

Abdominal Functional Electrical Stimulation to Assist Ventilator Weaning in Acute Tetraplegia: A Cohort Study. [2018]