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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electrical stimulation (Transcutaneous Electrical Stimulation) can improve movement in individuals with paralysis or weakness in their arms, hands, legs, or feet. It targets those who have experienced spinal cord injuries, strokes, or other brain or nerve injuries. Participants will receive treatments involving small electrical impulses sent to muscles or the spinal cord to encourage movement. Ideal candidates are those who have difficulty using a limb due to such injuries and are willing to attend frequent sessions over several months. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that this investigational neurostimulation device is safe for improving functional movements in individuals with paralysis or paresis?

Research has shown that using small electric currents to stimulate nerves, known as transcutaneous electrical stimulation, is generally safe for people. Studies have found that this method can help manage pain and improve function without major side effects. For instance, it has successfully relieved pain in people with spinal cord injuries, indicating it is well-tolerated.

Moreover, the FDA has approved a similar device that stimulates the spine without surgery for treating certain spinal cord injuries. This approval confirms the device meets safety standards for these cases.

In summary, while this specific trial is in the early stages, existing evidence supports the safety of transcutaneous electrical stimulation in similar situations. Based on previous use in humans, participants can expect the treatment to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about transcutaneous electrical stimulation because it offers a non-invasive way to help restore movement in individuals with paralysis or paresis from spinal cord injuries, strokes, or other brain and nerve injuries. Unlike traditional rehabilitation therapies that rely on physical exercises, this technique uses electrical currents to directly stimulate nerves and muscles, potentially enhancing recovery of motor functions. This approach could be particularly beneficial for those who have had limited success with conventional therapies, offering a faster and possibly more effective route to regaining mobility.

What evidence suggests that this neurostimulation device is effective for improving functional movements in individuals with paralysis or paresis?

Research has shown that electrical stimulation on the skin can help individuals with paralysis or weakness improve movement after spinal cord injuries or strokes. In this trial, participants with spinal cord injuries, strokes, or other brain and nerve injuries will receive transcutaneous electrical stimulation to evoke various movements. One study found that combining this stimulation with physical exercises improved muscle strength and walking ability. Another study discovered that this stimulation also relieved pain for those with spinal cord injuries. Although improvements often required several sessions, significant progress appeared with ongoing treatment. These findings suggest that this method can enhance recovery of movement in affected limbs. ^{1 2 5 6 7}

Who Is on the Research Team?

Chad E Bouton, MS

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04755699

Study Details | NCT04755699 | Chronic Transcutaneous ... This is an early feasibility trial to determine whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8954138/

Trans-Spinal Electrical Stimulation Therapy for Functional ... Conventional treatment approaches aim to reduce secondary complications and improve the functions that have been retained after the injury [13].

3. nature.com nature.com/articles/s41393-022-00776-z

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

5. mdpi.com mdpi.com/2076-3425/14/7/640

Transcutaneous Electrical Spinal Cord Stimulation ... ABT+TSCS increased the target-specific lower limb muscle strength and walking ability more than ABT alone in an individual with chronic iSCI.

6. embs.org embs.org/pulse/articles/fda-cleared-noninvasive-spine-stimulation-system-could-transform-spinal-cord-injury-treatment/

FDA-Cleared Noninvasive Spine Stimulation System Could ... Designed for people with chronic, nonprogressive neurological deficits resulting from incomplete SCIs between the second cervical nerve (C2) and ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537188/

Transcutaneous Electrical Nerve Stimulation - StatPearls - NCBI Transcutaneous electrical nerve stimulation (TENS) is a therapeutic modality employing electric current to relieve pain by activating peripheral nerves.