Electrical Stimulation for Paralysis/Paresis

Overseen By Erona Ibroci, MPH

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwell Health

Must not be taking: Botulinum toxin

Disqualifiers: Epilepsy, Implanted devices, Substance abuse, 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: 6

Duration: 12 months

28 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device improves functional arm/hand movements in individuals with paralysis or paresis due to a spinal cord injury or stroke and improves functional arm/hand or leg/foot movements in individuals with paralysis or paresis due to other brain or nerve injuries. In this study, eligible individuals that agree to participate will be asked to attend up to 5 study sessions a week for 1 year (depending on participant availability), with each session lasting up to 4 hours. At the first study session, participants will have their demographic information collected, vital signs assessed, and have measurements performed of their limbs and torso, as appropriate. They will also undergo clinical evaluations and tests to assess their current functional movement and sensation capabilities. During subsequent study sessions, participants will undergo many tasks designed to improve functional movements in paralyzed limbs. Specifically, participants will receive neuromuscular electrical stimulation to the limb(s) and/or electrical stimulation to the spinal cord to evoke specified movements. The stimulation parameters and locations on the spinal column and/or limb(s) that evoke specific movements will be noted. The movements will be assessed with visual inspection, electromyography, and/or sensors. The clinical evaluations and tests to assess functional movement and sensation capabilities will be repeated throughout the study and at the last study session to assess for functional improvements compared to the first study session. Upon completion of these study sessions, the individual's participation in the study is considered complete.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have severe spasticity that is not controlled by medication, it may affect your eligibility.

What data supports the effectiveness of the treatment Transcutaneous Electrical Stimulation for paralysis/paresis?

Research shows that transcutaneous electrical stimulation can help improve muscle strength, motor control, and reduce spasticity (muscle stiffness) in patients with spinal cord injuries and cerebral palsy. It has also been shown to promote long-term recovery of upper extremity function in individuals with chronic spinal cord injuries. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Electrical stimulation methods like transcutaneous electrical muscle stimulation and low-intensity transcranial electrical stimulation are generally considered safe, with good tolerability and no serious adverse events reported in many sessions. However, there is a risk of skin burns if the equipment is not used properly, and mild side effects like headaches and fatigue can occur. ^{2 6 7 8 9}

How is the treatment of Transcutaneous Electrical Stimulation unique for paralysis/paresis?

Transcutaneous Electrical Stimulation is unique because it uses electrical currents to stimulate muscles and nerves through the skin, helping to improve muscle strength, control, and movement in people with paralysis or weakness. Unlike some other treatments, it can be combined with therapies like exercise or botulinum toxin for added benefits, and it can be tailored to trigger specific muscle movements, aiding in tasks like walking or grasping. ^{1 3 10 11 12}

Research Team

Chad E Bouton, MS

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for individuals aged 18-75 with paralysis or paresis due to spinal cord injury, stroke, or other brain/nerve injuries. Healthy volunteers without physical disabilities are also eligible. Participants must be English proficient, able to understand the study, and commit to frequent visits over a year.

Inclusion Criteria

I am 18-75, healthy, understand English, and can visit the study center.

I am 18-75, had a stroke or spinal cord injury over a year ago, and struggle to use one hand.

Exclusion Criteria

Individuals participating in another study that may affect the conduct or results of this study

I do not have severe pressure ulcers, epilepsy, implanted devices, or other listed conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including demographic information, vital signs, and functional movement and sensation capabilities

1 session

1 visit (in-person)

Treatment

Participants receive neuromuscular and/or spinal cord stimulation to improve functional movements

12 months

Up to 5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Electrical Stimulation

Trial Overview The trial tests if transcutaneous electrical stimulation improves arm/hand and leg/foot function in paralyzed or weakened limbs. It involves up to five sessions per week for one year with tasks designed to enhance movement through neuromuscular and spinal cord stimulation.

Participant Groups

Group I: Individuals with other Brain or Nerve Injuries Experimental Treatment 1 Intervention

This arm consists of individuals with a other brain and nerve injuries receiving transcutaneous electrical stimulation to the arms/hand, legs/foot, and/or spinal column to evoke various arm/hand or leg/foot movements.

Group II: Individuals with a Stroke Experimental Treatment 1 Intervention

This arm consists of individuals with a stroke receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.

Group III: Individuals with a Spinal Cord Injury Experimental Treatment 1 Intervention

This arm consists of individuals with a spinal cord injury receiving transcutaneous electrical stimulation to the arms/hand and/or spinal column to evoke various arm/hand movements.

Group IV: Healthy Volunteers Active Control 1 Intervention

This arm consists of healthy volunteers receiving transcutaneous electrical stimulation to the arms, legs, and/or spinal column to evoke various arm/hand and leg/foot movements.

Transcutaneous Electrical Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Transcutaneous Electrical Stimulation for:

• Paralysis or paresis due to spinal cord injury or stroke
• Paralysis or paresis due to other brain or nerve injuries

Approved in European Union as Transcutaneous Electrical Stimulation for:

• Spinal cord injury rehabilitation
• Neuromuscular rehabilitation

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Findings from Research

Transcutaneous electrical stimulation can effectively improve muscle strength, motor control, and reduce spasticity in patients with upper motor neurone lesions, enhancing their overall functional condition.

Combining neuromuscular electrical stimulation with treatments like botulinum toxin and exercise therapy may provide additional benefits, although the current evidence is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. Schuhfried, O., Crevenna, R., Fialka-Moser, V., et al.[2022]

Transcutaneous electrical stimulation in 44 patients with spinal cord injuries significantly reduced spasticity and improved both passive and active movement, as well as respiratory function.

The treatment also restored normal blood pressure and neurogenic bladder functions, indicating a broad range of benefits beyond just spasticity reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of spinal spasticity by electrical stimulation. Franek, A., Turczynski, B., Opara, J.[2019]

Electrical stimulation can effectively reduce spasticity in approximately 50% of paraplegic and hemiplegic patients, with effects lasting over 30 minutes after stimulation.

In multiple sclerosis patients, continuous spinal cord stimulation showed short-term benefits, but stopping the stimulation led to a significant increase in reflex activity and a decrease in voluntary muscle strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation for control of paralysis and therapy of abnormal movements. Vodovnik, L., Rebersek, S., Stefanovska, A., et al.[2006]

Transcutaneous electrical spinal cord stimulation combined with physical therapy led to significant improvements in upper extremity function for a 62-year-old male with a chronic incomplete spinal cord injury, including a 52-point increase in strength and sensation scores after four weeks of treatment.

Remarkably, the functional gains achieved persisted for over three months after the treatment ended, indicating that this noninvasive approach can promote lasting neuroplasticity and recovery in individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. Inanici, F., Samejima, S., Gad, P., et al.[2020]

In a study involving six children with mild cerebral palsy, overnight low-intensity transcutaneous electrical stimulation (ES) led to significant improvements in motor skills after 6 months, as measured by the Peabody Developmental Motor Scales.

When ES was stopped for 6 months, the children experienced a uniform decline in their motor skills, but resuming ES resulted in further significant improvements, suggesting that ES can be a beneficial adjunct to standard rehabilitation for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular approach to the motor deficits of cerebral palsy: a pilot study. Pape, KE., Kirsch, SE., Galil, A., et al.[2006]

Transcutaneous electrical muscle stimulation (TEMS) was found to be safe and well-tolerated in 19 patients with acute exacerbations of chronic obstructive pulmonary disease (COPD), who participated in an average of 15 training sessions during hospitalization.

The study suggests that TEMS could be a promising intervention for COPD patients, paving the way for future research to explore its specific benefits when combined with other treatments like nutrition and medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. Meglic, U., Sorli, J., Kosnik, M., et al.[2021]

Electric stimulation is commonly used for diagnosis and therapy in spinal cord injury patients, but it can lead to tissue burns, as demonstrated in two reported cases.

To prevent burns during electric stimulation, it is crucial to use electrodes with a large surface area, ensure uniform contact with the skin, maintain a good conducting interface, provide adequate ventilation for heat dissipation, and avoid sharp electrode corners or damaged wires.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Burns in functional electric stimulation: two case reports. Balmaseda, MT., Fatehi, MT., Koozekanani, SH., et al.[2004]

Low intensity transcranial electrical stimulation (TES) is considered safe, with no serious adverse events reported in over 18,000 sessions across various populations, including healthy individuals and patients with neurological or psychiatric conditions.

While moderate adverse events like skin burns from tDCS are rare, mild adverse events such as headaches and fatigue are more common, and the safety profile is consistent across different age groups and vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Antal, A., Alekseichuk, I., Bikson, M., et al.[2023]

A long-term home-based functional electrical stimulation cycling program led to an 18.5% increase in total body lean mass and only a small increase in body fat for a 52-year-old male with chronic spinal cord injury, suggesting positive changes in body composition.

While there was a slight decrease in bone mineral content, the overall results indicate that FES cycling may provide cardio-metabolic benefits for individuals with paralysis, although this conclusion is based on a single case study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a fifty-six month electrical stimulation cycling program after tetraplegia: case report. Dolbow, DR., Gorgey, AS., Khalil, RK., et al.[2018]

A new functional electrical stimulation (FES) system using multi-pad electrodes was developed to improve grasping ability in stroke patients, allowing for targeted activation of motoneurons for better functional movement.

Testing on three stroke patients demonstrated that the multi-pad electrodes effectively generated a functional grasp and could be customized for individual patient needs, indicating potential for both clinical and home rehabilitation settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-pad electrode based functional electrical stimulation system for restoration of grasp. Malešević, NM., Popović Maneski, LZ., Ilić, V., et al.[2021]

A new method of functional electrical stimulation therapy was applied to a male participant in his 40s with severe hemiparesis, showing noticeable improvement in motor function within just two weeks of treatment, which was maintained for about a year.

This therapy combines forced contraction, mirror therapy, and repetitive exercise, suggesting it could be beneficial for patients with central motor palsy who lack muscle contraction ability, especially after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contralaterally-controlled functional electrical stimulation-induced muscle contraction for severe lower extremity paralysis. Imura, T., Wada, H., Matsui, M., et al.[2023]

Functional electrical stimulation (FES) has effectively decreased muscle spasticity and improved limb control in patients with spinal cord injuries and strokes, leading to better limb positioning and reduced contracture formation.

Patients using FES as a motor prosthesis have gained greater independence in daily activities, particularly those with spinal cord injuries at C4, C5, and C6 levels, highlighting its clinical efficacy and potential for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity applications of functional neuromuscular stimulation. Billian, C., Gorman, PH.[2006]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Non-invasive neuromuscular electrical stimulation in patients with central nervous system lesions: an educational review. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of spinal spasticity by electrical stimulation. [2019]

3. Sweden pubmed.ncbi.nlm.nih.gov

Electrical stimulation for control of paralysis and therapy of abnormal movements. [2006]

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

Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. [2020]

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

Neuromuscular approach to the motor deficits of cerebral palsy: a pilot study. [2006]

6. Austria pubmed.ncbi.nlm.nih.gov

Feasibility of transcutaneous electrical muscle stimulation in acute exacerbation of COPD. [2021]

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

Burns in functional electric stimulation: two case reports. [2004]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effects of a fifty-six month electrical stimulation cycling program after tetraplegia: case report. [2018]

10. England pubmed.ncbi.nlm.nih.gov

A multi-pad electrode based functional electrical stimulation system for restoration of grasp. [2021]

11. Japan pubmed.ncbi.nlm.nih.gov

Contralaterally-controlled functional electrical stimulation-induced muscle contraction for severe lower extremity paralysis. [2023]

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

Upper extremity applications of functional neuromuscular stimulation. [2006]