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

36 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Stochastic Resonance Electric Stimulation for cerebral palsy?

Research shows that Stochastic Resonance Stimulation can improve balance in children with cerebral palsy by enhancing sensory input detection. Similar treatments have also been effective in improving balance in elderly individuals and those with diabetic neuropathy or after a stroke. ^{1 2 3 4 5}

Is electrical stimulation safe for use in humans?

Research shows that electrical stimulation, including types like Neuromuscular Electrical Stimulation (NMES) and Functional Electrical Stimulation (FES), is generally safe and well-tolerated in humans, including children with disabilities. Reports of direct adverse reactions are rare, and safety principles have been established over more than 40 years of research. ^{6 7 8 9 10}

How is the treatment Stochastic Resonance Electric Stimulation unique for cerebral palsy?

Stochastic Resonance Electric Stimulation is unique for cerebral palsy as it uses a specific level of noise to enhance the body's ability to detect and respond to weak sensory signals, improving balance and postural control, which is a novel approach for this condition. ^{1 2 5 11 12}

What is the purpose of this trial?

The purpose of this study is to investigate whether a light electrical stimulation to leg muscles and joints can help people with Cerebral Palsy (CP) maintain balance during everyday tasks such as getting up from a chair and walking. Children and young adults with CP can have trouble with daily tasks such as standing up, sitting down on the chair and turning. The difficulty in maintaining balance sometimes lead to falls. This raises risk of disability in CP as children age into teens and adults. Current treatments are not very effective. In this study, children and young adults will be asked to stand up from a stool, walk in a straight line, turn, walk back and sit down on the stool. Participants will receive electrical stimulation at a very low intensity that cannot be felt to help increase their sensory perception. The investigators will evaluate treatment by testing balance, and other functional measures.

Research Team

Samuel Lee, PT, PhD

Principal Investigator

University of Dealware

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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 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 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 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]

References

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

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

2. Germany pubmed.ncbi.nlm.nih.gov

Improving balance function using vestibular stochastic resonance: optimizing stimulus characteristics. [2021]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Subthreshold electrical noise alters walking balance control in individuals with cerebral palsy. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Stochastic resonance stimulation improves balance in children with cerebral palsy: a case control study. [2019]

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

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

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

Functional electrical stimulation for neuromuscular applications. [2022]

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

Stochastically modulated inter-pulse intervals to increase the efficiency of functional electrical stimulation cycling. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review. [2022]

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

Magnetic Field Reference Levels for Arbitrary Periodic Waveforms for Prevention of Peripheral Nerve Stimulation. [2018]

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

Stochastic Resonance Effects on Apnea, Bradycardia, and Oxygenation: A Randomized Controlled Trial. [2020]

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

Stochastic resonance in the motor system: effects of noise on the monosynaptic reflex pathway of the cat spinal cord. [2007]