Electric Stimulation for Cerebral Palsy

Overseen By Khushboo Verma, PT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Botulinum toxin

Disqualifiers: Scoliosis, Joint instability, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether gentle electrical stimulation, known as Stochastic Resonance Electric Stimulation, can help individuals with Cerebral Palsy (CP) improve balance during activities like standing and walking. The goal is to determine if this treatment can reduce fall risk and enhance mobility for children and young adults with CP, who often face challenges with these tasks. Participants will be divided into two groups: one will receive the electrical stimulation, and the other will not. The trial seeks children and young adults aged 10-21 with CP who can stand from a chair and begin walking. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve daily life for those with CP.

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, it mentions that participants should be seizure-free or have well-controlled seizures, which might imply that continuing seizure medication is allowed.

What prior data suggests that this electrical stimulation is safe for people with Cerebral Palsy?

Research has shown that a special type of gentle electrical stimulation is generally safe and well-tolerated in children with cerebral palsy. Studies have found that this treatment can help improve balance in these children. Most children did not feel the mild electrical pulses. However, one report noted a slight reduction in balance in one child with cerebral palsy and three children without it.

This suggests that while the treatment is mostly safe, its effects may vary. Importantly, the reviewed studies reported no serious side effects or harmful events. Prospective trial participants might find this information helpful in understanding what to expect regarding safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stochastic Resonance Electric Stimulation for cerebral palsy because it offers a unique approach by using random electrical noise to enhance the body's natural sensory signals. Unlike traditional treatments such as physical therapy or medication that primarily focus on managing symptoms, this method directly targets the nervous system to improve motor function. The potential to enhance postural transitions and mobility in real-time makes it a promising option for improving daily life activities for individuals with cerebral palsy.

What evidence suggests that this electrical stimulation is effective for improving balance in Cerebral Palsy?

Research has shown that a gentle electrical stimulation called Stochastic Resonance Electric Stimulation might improve balance in children with cerebral palsy (CP). One study found that this stimulation aids children with CP by sending light electrical signals that enhance their body's ability to sense position. Another study demonstrated improved mobility, particularly in activities like standing and running, with this stimulation. Additionally, electrical stimulation has increased muscle strength and size in children with CP, aiding their movement. In this trial, some participants will receive Stochastic Resonance stimulation during activities, while others will perform the same activities without electrical stimulation. Overall, these findings suggest that this treatment could help children with CP maintain better balance and movement in daily activities. ^{1 2 6 7 8}

Who Is on the Research Team?

Samuel Lee, PT, PhD

Principal Investigator

University of Dealware

Are You a Good Fit for This Trial?

This trial is for children and young adults aged 8-24 with Cerebral Palsy (CP), specifically those who can stand up from a chair and walk but have difficulty maintaining balance. They should not have other neurological or musculoskeletal disorders, be seizure-free or have well-controlled seizures, and possess sufficient cognitive skills to communicate discomfort.

Inclusion Criteria

You have mild to moderate motor function.

You do not have any diagnosed neurological or balance disorders.

You must be between 8 and 24 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants perform postural transitions with and without stochastic resonance stimulation to evaluate balance and functional measures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stochastic Resonance Electric Stimulation

Trial Overview

The study tests if light electrical stimulation called Stochastic Resonance Electric Stimulation on leg muscles helps improve balance during tasks like standing up, walking, turning around, and sitting down. Participants will perform these activities while receiving imperceptible electric stimulation to enhance sensory perception.

How Is the Trial Designed?

Group I: Stochastic Resonance stimulation Experimental Treatment 1 Intervention

During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test while receiving stochastic resonance stimulation on legs and hip.

Group II: No Stochastic Resonance stimulation Active Control 1 Intervention

During this condition, participants will perform postural transitions like sit to stand, gait initiation, sit to walk and Timed Up and Go test without receiving any electrical stimulation.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Published Research Related to This Trial

In a study involving 17 able-bodied participants, constant frequency stimulation (P1) produced a higher mean power output (12.57 W) compared to stochastic inter-pulse interval stimulation (P2) (11.44 W), indicating that randomized modulation may not be as effective for power generation during functional electrical stimulation cycling.

The results suggest that while stochastic modulation can be explored, it may negatively impact power output, and assessments should focus on periods of isolated quadriceps stimulation to minimize the influence of voluntary muscle contractions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stochastically modulated inter-pulse intervals to increase the efficiency of functional electrical stimulation cycling. Aksöz, EA., Luder, MA., Laubacher, M., et al.[2022]

A review of 37 studies indicates that therapeutic electrical stimulation (ES) can lead to significant improvements in various functional impairments in children, particularly those with cerebral palsy, enhancing muscle strength, range of motion, and walking speed.

Electrical stimulation techniques, such as neuromuscular electrical stimulation (NMES) and functional electrical stimulation (FES), are found to be safe and well-tolerated in pediatric patients, with rare reports of adverse reactions, suggesting their potential for broader clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review. Bosques, G., Martin, R., McGee, L., et al.[2022]

This study provides the first direct evidence that stochastic resonance (SR) occurs in the motor system, specifically at the Ia-motoneuron synapse in cats, enhancing reflex responses to weak stimuli.

By applying mechanical noise through random stretches to a muscle, researchers found that the strength of monosynaptic reflexes showed an inverted U-shaped relationship with the level of noise, indicating that a certain amount of noise optimizes motor responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stochastic resonance in the motor system: effects of noise on the monosynaptic reflex pathway of the cat spinal cord. Martínez, L., Pérez, T., Mirasso, CR., et al.[2007]

Stochastic Resonance (SR) stimulation significantly improved walking balance in individuals with cerebral palsy (CP) by increasing the minimum lateral margin of stability, indicating enhanced stability during walking.

The study involved 34 participants (17 with CP and 17 typically developing controls) and found that SR stimulation led to a more conservative walking strategy in the CP group, potentially reducing fall risk by improving their awareness of body motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthreshold electrical noise alters walking balance control in individuals with cerebral palsy. Sansare, A., Reimann, H., Crenshaw, J., et al.[2023]

A new stochastic model was developed to simulate knee movements in response to electrical stimulation of the quadriceps and hamstrings, accounting for factors like muscle fatigue and daily variations, based on data from a subject with complete spinal cord injury.

The model revealed significant differences in knee angle responses between the left and right legs, highlighting the importance of considering fatigue and variability in designing effective electrically stimulated systems for joint movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A stochastic model of knee angle in response to electrical stimulation of the quadriceps and hamstrings muscles. Lynch, CL., Popovic, MR.[2011]

Functional electrical stimulation (FES) can effectively induce muscle contractions in paralyzed or weak muscles by applying electrical currents to the intact peripheral motor nerves, providing a means to restore function in various body systems.

Over 40 years of research have led to the development of safe and effective FES systems for different applications, with ongoing technological advancements promising more integrated and versatile neuroprosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation for neuromuscular applications. Peckham, PH., Knutson, JS.[2022]

In a study of 36 preterm infants, stochastic resonance (SR) stimulation significantly reduced apneic events by 50%, indicating its potential effectiveness in managing breathing issues in these vulnerable infants.

SR stimulation also led to a 20% to 35% decrease in the number, duration, and intensity of oxygen desaturation events, as well as a nearly 20% reduction in the intensity of bradycardia events, suggesting it could be a safe, noninvasive treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. Smith, VC., Kelty-Stephen, D., Qureshi Ahmad, M., et al.[2020]

This study establishes a method for deriving reference levels (RLs) for preventing nerve stimulation from low-frequency magnetic fields, using data from human MRI experiments to determine specific thresholds for various waveforms.

The findings indicate that both sinusoidal and non-sinusoidal waveforms can be assessed using the same criteria for potential nerve stimulation, simplifying the evaluation process against existing exposure standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Field Reference Levels for Arbitrary Periodic Waveforms for Prevention of Peripheral Nerve Stimulation. Gajda, GB., Bly, SH.[2018]

In a study involving 15 healthy subjects, low-amplitude stochastic vestibular electrical stimulation significantly improved balance performance by 5-26%, demonstrating the effectiveness of stochastic resonance in enhancing stability.

The optimal stimulation amplitude for improving balance was found to be between ±100 to ±400 μA, suggesting potential applications for a wearable device to assist individuals with balance issues due to aging or disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. Mulavara, AP., Fiedler, MJ., Kofman, IS., et al.[2021]

Stochastic Resonance (SR) electrical stimulation significantly improved postural stability in children with cerebral palsy (CP) by reducing center of pressure velocity and area, particularly when their eyes were open, indicating its potential as a therapeutic tool for balance enhancement.

The study involved 20 participants (10 with CP and 10 typically developing peers) and highlighted the importance of using individualized SR stimulation intensities to maximize balance improvements, suggesting that sensory facilitation methods could enhance rehabilitation for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study. Zarkou, A., Lee, SCK., Prosser, LA., et al.[2019]

A new electrical stimulator using stochastic resonance has been developed to potentially enhance postural control in elderly individuals, those with diabetic neuropathy, and stroke patients.

The device features four programmable channels and two stimulation modes, allowing for tailored treatment, which may improve balance and stability in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A microprocessor-based multichannel subsensory stochastic resonance electrical stimulator. Chang, GC.[2020]

Neuromuscular electrical stimulation (NMES) significantly improves mobility in children with spastic cerebral palsy, as shown by greater walking speed and enhanced performance in standing, running, and jumping activities based on a meta-analysis of 14 randomized controlled trials involving 421 patients.

The treatment was found to be safe for children with spastic cerebral palsy, indicating that NMES can be a beneficial therapeutic option alongside conventional physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of neuromuscular electrical stimulation in improving mobility in children with cerebral palsy: A systematic review and meta-analysis of randomized controlled trials. Chen, YH., Wang, HY., Liao, CD., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30526617/

Stochastic resonance stimulation improves balance in ...

Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study · Authors · Affiliations.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35730135/

Effectiveness of neuromuscular electrical stimulation in ...

Neuromuscular electrical stimulation improved mobility in children with spastic cerebral palsy, particularly in standing, running, and jumping function.

3.

jneuroengrehab.biomedcentral.com

jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0467-7

Stochastic resonance stimulation improves balance in ...

Specifically, the addition of SR stimulation diminished balance performance in 1 child with CP and 3 children with TD whereas the remaining ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/dmcn.12955

Neuromuscular electrical stimulation‐assisted gait ...

Eight weeks of daily NMES-assisted gait increases muscle volume and strength of the stimulated ankle dorsiflexors in children with unilateral spastic CP.

5.

researchgate.net

researchgate.net/publication/330664299_Neuromuscular_electrical_stimulation_to_improve_gross_motor_function_in_children_with_cerebral_palsy_a_meta-analysis

Neuromuscular electrical stimulation to improve gross ...

Neuromuscular electrical stimulation (NMES) applied to the triceps surae muscle is claimed to be effective in improving gait in children with cerebral palsy.

6.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/pdf/10.1002/pmrj.12788

Effects of Stochastic Resonance Stimulation on Manual ...

Abstract. Objective: To investigate the effect of stochastic resonance stimulation (SRS) on manual abilities in children with hemiplegic ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5683854/

Neuromuscular Electrical Stimulation for Treatment of Muscle ...

This article provides physiotherapists with a resource to enable evidence-informed, effective use of NMES for PT practice.

8.

researchgate.net

researchgate.net/publication/388821216_A_systematic_review_and_meta-analysis_of_neuromuscular_electrical_stimulation_post-botulinum_toxin_injection_in_children_with_cerebral_palsy

A systematic review and meta-analysis of neuromuscular ...

The aim of our study is to investigate whether adjunct neuromuscular electrical stimulation (NMES) therapy improves functional performance ...