Muscle Training + Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Michele Basso, EdD, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Botox, Anti-coagulation therapy

Disqualifiers: Neurologic conditions, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: 39

Duration: 12 weeks

49 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new rehab program for individuals recovering from spinal cord injuries (SCI), aiming to improve walking and movement. The program includes walking downhill on a treadmill with mild electrical stimulation to enhance muscle function. Researchers will analyze blood and spinal fluid to determine the optimal time to start treatment, either immediately or after a three-month wait. Individuals who have had an SCI within the last 1 to 5 months and have completed inpatient rehab may be suitable candidates. The trial will compare the results of this new approach with those from standard rehab alone. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance rehabilitation options for SCI patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using botox that affects muscle function or are on anti-coagulation therapy, you may not be eligible to participate.

What prior data suggests that this rehabilitation treatment is safe for individuals with spinal cord injury?

Research shows that using electrical stimulation to train muscles in people with spinal cord injuries is generally safe. Studies have found it can strengthen muscles and improve function without causing serious issues. Some individuals might experience mild tingling or discomfort at the electrode sites. Other research indicates that walking downhill on a treadmill, part of this new treatment, can lead to positive changes in the brain and spinal cord. This suggests the treatment might be safe and beneficial for improving movement. Overall, existing evidence supports that this combined approach is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach for spinal cord injury recovery by combining muscle training with electrical stimulation. Unlike standard therapies that mainly focus on physical rehabilitation, this method uses downhill eccentric treadmill training which uniquely challenges muscles in a way that's typically less emphasized. The addition of electrical stimulation aims to enhance muscle activation and improve outcomes by potentially reducing inflammation and promoting nerve regeneration. This innovative combination could offer new insights and hope for improving mobility and quality of life in spinal cord injury patients.

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

Research has shown that combining electrical stimulation with exercises can strengthen muscles and increase their size in people with partial spinal cord injuries. In this trial, participants in the experimental groups will undergo Downhill Eccentric Treadmill Training with Electrical Stimulation. Studies indicate that this method can enhance movement in the trunk and legs, aiding in walking and overall function. Evidence also suggests that training with downhill walking might improve nerve signal transmission. By combining these methods, participants may achieve better results in regaining movement after a spinal cord injury. These findings suggest that this treatment could effectively help people recover movement and function. ^{1 2 3 5 6}

Who Is on the Research Team?

Michele Basso, EdD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with spinal cord injury (SCI) within 1-5 months post-injury, discharged from inpatient rehab, and without recent surgeries or major injuries. Healthy controls of the same age range can also join if they meet similar health criteria. Participants must not have conditions like active cancer or clotting disorders, be pregnant, or have cognitive issues preventing consent.

Inclusion Criteria

I had a spinal cord injury between 1-5 months ago, am aged 18-85, and have been discharged from rehab.

I am between 18-85 years old, with no recent major injuries or surgeries.

Exclusion Criteria

I do not have implanted devices unsuitable for MRI, neurological conditions, current cancer, clotting disorders, inflammatory conditions, am not pregnant, and can undergo procedures involving needles and confined spaces.

SCI participants: Use of botox in the past 3 months that reduces skeletal muscle function; other neurologic conditions (i.e. brain injury, stroke, HIV); current cancer diagnosis; active deep vein thrombosis and anti-coagulation therapy; skin wounds in regions that interfere with harness, stimulation pads or hand placement needed for training; pregnancy; ventilator-dependence; cognitive conditions that preclude providing informed consent; Implanted medical devices that are contraindicated for electrical stimulation or MRI (If SCI participants have conditions contraindicated for MRI they may still participate in the remainder of study activities without myelin status as an outcome measure. SCI is a rare condition therefore this is necessary in order to achieve the required sample size.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Assessment

Collection and analysis of cerebrospinal fluid and blood to determine inflammatory status and readiness for training

3 months

1-2 visits (in-person)

Treatment

12-week downhill training program combined with electrical stimulation, conducted 3 times a week

12 weeks

36 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including biomechanical analysis and clinical outcome measures

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Downhill Eccentric Treadmill Training with Electrical Stimulation

Trial Overview

The study tests a new rehabilitation treatment combining downhill treadmill training with electrical muscle stimulation against standard rehab alone. It aims to determine the optimal timing to start this program by analyzing biomarkers in blood and spinal fluid and assessing recovery of movement through MRI scans.

How Is the Trial Designed?

Group I: SCI No Go Experimental Treatment 1 Intervention

Participants with SCI randomized to the experimental group that have biomarkers that indicate high levels of inflammation will have a delayed start of 3 months.

Group II: SCI Go Experimental Treatment 1 Intervention

Participants with SCI randomized to the experimental group that have biomarkers that indicate low levels of inflammation will start immediately.

Group III: SCI SOC Active Control 1 Intervention

Participants with SCI randomized to the standard of care (SOC) group will continue with regular therapy.

Group IV: Healthy Control Active Control 1 Intervention

Healthy controls will provide biomarker and/or myelin (MRI) data

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

University of Notre Dame

Collaborator

Trials

36

Recruited

60,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

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]

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]

Participants with acute spinal cord injury who trained with a robotic exoskeleton and functional electrical stimulation showed significant improvements in muscle volume compared to those receiving standard care alone, indicating enhanced muscle function.

Both groups experienced improvements in static balance, but the intervention group demonstrated greater enhancements, suggesting that early robotic exoskeleton training may be beneficial for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle adaptations in acute SCI following overground exoskeleton + FES training: A pilot study. Hohl, K., Smith, AC., Macaluso, R., et al.[2022]

In a study involving 28 participants with incomplete spinal cord injury, combining progressive resistance training (PRT) with functional electrical stimulation-evoked leg cycling exercise (FES-LCE) significantly improved muscle strength, with the left hamstrings showing a 45% increase in peak torque compared to a 4% increase in the FES-LCE only group.

The combination intervention also led to a notable increase in muscle volume in the left leg after 12 weeks, demonstrating that PRT enhances the effectiveness of FES-LCE for improving muscle outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a combined progressive resistance training and functional electrical stimulation-evoked cycling exercise on lower limb muscle strength of individuals with incomplete spinal cord injury: A randomized controlled study. Rosley, N., Hasnan, N., Hamzaid, NA., et al.[2023]

In a study involving 12 individuals with complete spinal cord injury, FES-assisted dynamic load-shifting exercises led to significant increases in trabecular bone mineral density (vBMD) in the proximal and distal tibia after 29 weeks of training, indicating potential benefits for bone health in this population.

While improvements were noted in the tibia, there was no increase in vBMD in the distal femur, suggesting that the effectiveness of FES exercises may vary by bone location and type of exercise performed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of Functional Electrical Stimulation-assisted posture-shifting in bone mineral density: case series-pilot study. Armengol, M., Zoulias, ID., Gibbons, RS., et al.[2022]

Robotic body weight supported treadmill training shows positive effects on walking parameters in patients with spinal cord injuries, particularly among younger individuals and those with subacute injuries, based on a systematic review of 10 studies involving 286 patients.

The studies utilized robotic devices like Lokomat and Gait Trainer, but the overall evidence is limited and of fair methodological quality, indicating a need for further research to strengthen the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Robotic systems for gait re-education in cases of spinal cord injury: a systematic review]. Gandara-Sambade, T., Fernandez-Pereira, M., Rodriguez-Sotillo, A.[2018]

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 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]

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 72 spinal cord injury patients, functional electrical stimulation (FES) combined with robot-assisted training significantly improved both FES-assisted and voluntary muscle strength in the lower limbs, indicating enhanced motor function.

The results showed a strong correlation between increases in FES-assisted strength and voluntary muscle function, suggesting that this combined approach may effectively support recovery of residual functions after spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted training with functional electrical stimulation enhances lower extremity function after spinal cord injury. Bersch, I., Alberty, M., Fridén, J.[2022]

After 9 weeks of locomotor training, individuals with chronic incomplete spinal cord injury showed significant improvements in muscle strength, particularly in the plantar-flexor muscles, with peak torque increasing by an average of 43.9%.

The training also led to enhanced muscle size and voluntary activation, indicating that locomotor training can effectively improve both muscle function and activation in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Locomotor training and muscle function after incomplete spinal cord injury: case series. Jayaraman, A., Shah, P., Gregory, C., 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]

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This first-in-human study investigated whether innovative, downhill locomotor rehabilitation promotes myelin plasticity in individuals with ...

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