Electrical Stimulation for Spinal Cord Injury

Overseen By Cristina Thurston, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Must not be taking: Investigational drugs

Disqualifiers: Traumatic brain injury, Stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on investigational drugs or any intervention that affects neuromotor function, you may not be eligible to participate.

What data supports the effectiveness of the treatment MyndMove Long Term Therapy for spinal cord injury?

Research shows that functional electrical stimulation (FES), like that used in MyndMove therapy, can help improve voluntary motor functions and upper extremity function in people with spinal cord injuries. Additionally, FES has been effective in helping some patients with spinal cord injuries to stand and walk, although its use can be limited by the time and effort required to operate the system. ^{1 2 3 4 5}

Is electrical stimulation therapy safe for humans?

Electrical stimulation therapies like Functional Electrical Stimulation (FES) and Neuromuscular Electrical Stimulation (NMES) have been used in rehabilitation for conditions like spinal cord injury and stroke. While these therapies can cause discomfort, they are generally considered safe for human use, with ongoing research to improve comfort and effectiveness. ^{1 5 6 7 8}

How is the MyndMove treatment different from other treatments for spinal cord injury?

The MyndMove treatment is unique because it uses a type of electrical stimulation that is designed to be more comfortable for patients, which can help them stick with the therapy longer. This treatment aims to improve voluntary motor functions and walking ability in people with spinal cord injuries by generating muscle contractions through electrical impulses. ^{1 4 5 9 10}

What is the purpose of this trial?

The purpose of this research is to examine the effects that functional electrical stimulation (FES) therapy has on the way the arms, brain and spinal cord work. The study team wants to understand what recovery looks like in persons with a spinal cord injury (SCI) or peripheral nerve injury (PNI) using the MyndMove (MyndTec Inc., Ontario, Canada) therapy system. This type of therapy uses stimulation to help people with SCI and other neurological conditions to perform common tasks, work out, or strengthen muscles.

Research Team

Matija Milosevic, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with spinal cord injury (SCI) or peripheral nerve injury (PNI) who are looking to improve their upper extremity function. Participants should be interested in undergoing functional electrical stimulation therapy.

Inclusion Criteria

Patients with neurological injury meeting the following criteria:

I have some muscle movement in one arm, confirmed by a muscle test.

I can see my muscle move in one of my arms when it is electrically stimulated.

Exclusion Criteria

I do not have major cognitive issues or severe health problems.

Patients with severe spasticity that could prevent the study protocol as determined by the investigator

Patients with poorly managed autonomic dysreflexia that could be triggered by FES

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Functional Electrical Stimulation (FES) therapy using the MyndMove system to improve upper extremity function

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MyndMove Long Term Therapy
• MyndMove Short Term Therapy

Trial Overview The study compares the effects of MyndMove therapy over different durations against conventional therapy on arm, brain, and spinal cord function after SCI or PNI. It aims to understand recovery patterns using this innovative FES system.

Participant Groups

Group I: Chronic SCI Group Experimental Treatment 3 Interventions

Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; more than 6 months post injury. Participants in this group will be in the study for up to 12 weeks

Group II: Chronic PNI Group Experimental Treatment 3 Interventions

Individuals with PNI that are 6 months or more post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks

Group III: Acute SCI Group Experimental Treatment 3 Interventions

Individuals with traumatic spinal cord injury (SCI) with a neurological level at or above T1 spinal cord level; Abbreviated Injury Scale (AIS) A, B, C or D impairment grade; less than 6 months post injury. Participants in this group will be in the study for up to 12 weeks

Group IV: Acute PNI Group Experimental Treatment 3 Interventions

Individuals with PNI that are within 6 months pre- or post-UE nerve transfer surgery. Participants in this group will be in the study for up to 12 weeks

MyndMove Long Term Therapy is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as MyndMove for:

• Spinal cord injury (SCI)
• Peripheral nerve injury (PNI)
• Upper extremity rehabilitation

Approved in United States as Functional Electrical Stimulation (FES) for:

• Spinal cord injury (SCI)
• Stroke rehabilitation
• Muscle retraining

Approved in European Union as MyndMove Therapy System for:

• Spinal cord injury (SCI)
• Neurological conditions
• Upper extremity rehabilitation

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

The MyndMove™ functional electrical stimulator provides more comfortable muscle contractions compared to the Compex Motion stimulator, particularly during high-intensity stimulation, as reported by 12 able-bodied participants in a controlled study.

Participants preferred MyndMove™ for 60% of contractions, suggesting that its ability to deliver less electrical charge for equivalent muscle contractions may enhance patient compliance and effectiveness of FES therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing preference related to comfort in torque-matched muscle contractions between two different types of functional electrical stimulation pulses in able-bodied participants. Garcia-Garcia, MG., Jovanovic, LI., Popovic, MR.[2022]

Functional electrical stimulation (FES) therapy using the Myndmove stimulator was found to produce clinically meaningful improvements in upper extremity function for individuals with tetraplegia, similar to conventional therapy, after 40 sessions over 14 weeks.

Despite both groups showing a 2-point increase in self-care scores (SCIM III-SC), there was no statistically significant difference between the FES and conventional therapy groups, indicating that while FES is effective, it may not provide additional benefits over standard rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. Anderson, KD., Korupolu, R., Musselman, KE., et al.[2023]

In a study of 40 subjects with spinal cord injury and cerebral damage, functional electrical stimulation (FES) during walking led to an average improvement in walking speed of over 20%, with total gains reaching 45% over a year.

The largest improvements were observed in the slowest walkers, and the acceptance of FES systems was high, indicating a promising role for FES in treating gait disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter evaluation of electrical stimulation systems for walking. Wieler, M., Stein, RB., Ladouceur, M., et al.[2019]

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 resistance training form of neuromuscular electrical stimulation (NMES) was successfully applied to individuals with motor complete spinal cord injury, leading to significant increases in muscle mass averaging 30% to 40% over 3 to 6 months of training.

Participants experienced no adverse events and showed consistent progress in their ability to perform more repetitions and lift heavier weights, indicating that NMES can effectively stimulate muscle growth and function even years after injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. Bickel, CS., Yarar-Fisher, C., Mahoney, ET., et al.[2018]

In a study involving 15 subjects, neuromuscular electrical stimulation (NMES) with a pulse duration of 500 μs was tolerated better than 200 μs, allowing for greater muscle torque at 49.3% of maximum voluntary isometric contraction (MVIC) compared to 44.5% (p=0.02).

This suggests that longer pulse durations may enhance patient comfort and potentially improve the effectiveness of NMES in treating muscle weakness, although further research is needed to determine if these differences translate into significant strength gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation pulse duration and maximum tolerated muscle torque. Scott, W., Flora, K., Kitchin, BJ., et al.[2014]

In a pilot study involving 8 patients with myotonic dystrophy type 1, functional electrical stimulation (FES) training was found to be safe and well-tolerated, leading to significant improvements in muscle strength and endurance compared to conventional training.

FES resulted in a greater increase in tibialis anterior muscle strength (effect size d = 1.583) and overall muscle strength (d = 1.723), suggesting it may be an effective rehabilitative approach for patients with severely compromised muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. Cudia, P., Weis, L., Baba, A., et al.[2018]

In a study involving 43 patients with chronic stroke, the hybrid treatment combining neuromuscular electrical stimulation (NMES) and noxious thermal stimulation (NTS) showed significant improvements in upper extremity recovery, as measured by the Fugl-Meyer assessment, compared to baseline.

However, the hybrid approach did not demonstrate superior efficacy over NMES or NTS alone, suggesting that while it is beneficial, it may not provide additional advantages beyond the individual treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. Chen, CC., Tang, YC., Hsu, MJ., et al.[2019]

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]

In a 1-year follow-up study of 17 patients with spinal cord injuries, functional electrical stimulation (FES) showed potential for improving standing and walking abilities, with paraplegic patients achieving a mean standing duration of 22.6 minutes.

Three patients with incomplete cervical lesions experienced significant improvements in their walking ability, with gait velocity and distance increasing by an average of 33.3% and 163.8%, respectively, after just 6 weeks of FES treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of functional electrostimulation in patients with paraplegia]. Hesse, S., Malezic, M., Lücke, D., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing preference related to comfort in torque-matched muscle contractions between two different types of functional electrical stimulation pulses in able-bodied participants. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to conventional therapy in incomplete tetraplegia. [2023]

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

Multicenter evaluation of electrical stimulation systems for walking. [2019]

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

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

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

Neuromuscular Electrical Stimulation-Induced Resistance Training After SCI: A Review of the Dudley Protocol. [2018]

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

Neuromuscular electrical stimulation pulse duration and maximum tolerated muscle torque. [2014]

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

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. [2019]

9. 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]

10. Germany pubmed.ncbi.nlm.nih.gov

[Value of functional electrostimulation in patients with paraplegia]. [2019]