Electrical Stimulation for Cerebral Palsy

Overseen By Jennifer M Kime, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Father Flanagan's Boys' Home

Disqualifiers: Pregnancy, Ferrous metal implants, 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: 3

Duration: 20 minutes

50 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.

What data supports the effectiveness of the treatment Transcutaneous Current Stimulation, Transcutaneous Electrical Stimulation, Transcutaneous Spinal Cord Stimulation, Non-Invasive Neuromodulation for cerebral palsy?

Research shows that using electrical stimulation techniques like transcutaneous electrical nerve stimulation (TENS) and spinal neuromodulation can improve movement and reduce muscle stiffness in children with cerebral palsy. These treatments have been shown to enhance motor skills and coordination, suggesting they may be beneficial for managing symptoms of cerebral palsy. ^{1 2 3 4 5}

Is electrical stimulation safe for humans?

Electrical stimulation methods like transcutaneous spinal cord stimulation (tSCS) and trans-spinal direct current stimulation (tsDCS) are generally considered safe, with no long-term side effects reported in studies. These techniques are non-invasive and have been used in various conditions, showing feasibility and safety in humans. ^{2 3 6 7 8}

How does the treatment Transcutaneous Current Stimulation differ from other treatments for cerebral palsy?

Transcutaneous Current Stimulation is unique because it is a non-invasive treatment that uses electrical currents to stimulate the spinal cord and improve motor function. Unlike other treatments, it can reorganize neural networks and enhance coordination and movement without surgery or medication, making it a novel approach for managing cerebral palsy. ^{1 2 4 5 9}

What is the purpose of this trial?

Specific Aim 1: To further quantify the difference in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence of persons with CP. Overall hypotheses: The sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be uncharacteristic in persons with CP when compared with neurotypical controls. Furthermore, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP. Specific Aim 2: To investigate the effect of transcutaneous current stimulation applied over the cortex and/or spinal cord on the sensorimotor cortical activity, spinal cord dynamics, and corticospinal coherence. Overall hypotheses: Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.

Research Team

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Eligibility Criteria

This trial is for individuals with Cerebral Palsy. It aims to understand and potentially improve how their brain and spinal cord work together. Participants should be able to undergo various non-invasive imaging tests like fMRI and MEG, as well as receive transcutaneous current stimulation.

Inclusion Criteria

For Neurotypical Controls: No known atypical neurodevelopment (e.g. autism, Down Syndrome, ADHD, etc.)

My cerebral palsy affects my movement but I can still move with or without aids.

Exclusion Criteria

For Cerebral Palsy Participants: Pregnancy

For Neurotypical Controls: Pregnancy

For Cerebral Palsy Participants: The presence of any ferrous metal implant, including orthodonture, which may interfere with the MEG data acquisition and/or be an MRI safety concern

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including clinical assessments, fMRI, MEG, and H-reflex protocols

1 hour

1 visit (in-person)

Treatment

Participants receive transcutaneous current stimulation over the cortex and/or spinal cord

20 minutes

1 visit (in-person)

Post-Treatment Assessment

Participants undergo post-treatment assessments including fMRI, MEG, or H-reflex protocols

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous Current Stimulation

Trial Overview The study is testing whether applying a mild electrical current over the skin (transcutaneous current stimulation) can change brain and spinal cord activity in people with CP. It includes detailed assessments of these activities using advanced imaging techniques.

Participant Groups

Group I: Neurotypical Youth/Adults Experimental Treatment 5 Interventions

Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of persons with CP.

Group II: Cerebral Palsy Youth/Adults Experimental Treatment 5 Interventions

Compared with the sham controls, those receiving the transcutaneous current stimulation will demonstrate alterations in the strength of the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence. Moreover, the extent of the alterations in the sensorimotor cortical activity, spinal cord activity, and corticospinal coherence will be tightly linked with the clinical presentations of controls.

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

Approved in United States as Transcutaneous Current Stimulation for:

• Spasticity management in cerebral palsy
• Chronic pain management

Approved in European Union as Transcutaneous Electrical Stimulation for:

• Spasticity management in cerebral palsy
• Rehabilitation post spinal cord injury

Who Is Running the Clinical Trial?

Father Flanagan's Boys' Home

Lead Sponsor

Trials

14

Recruited

1,600+

Findings from Research

A study involving 63 children with spastic cerebral palsy showed that combining transcranial pulsed current stimulation (tPCS) and transcutaneous electrical nerve stimulation (TENS) significantly improved lower limb spasticity compared to physiotherapy alone, with notable improvements in muscle tone and spasticity measures.

The combination therapy was safe and effective, demonstrating significant enhancements in the Modified Ashworth Scale and Modified Tardieu Scale scores after 12 weeks of treatment, indicating a promising new approach for managing spasticity in children with severe motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of combined transcranial pulsed current stimulation and transcutaneous electrical nerve stimulation on lower limb spasticity in children with spastic cerebral palsy: a randomized and controlled clinical study. Liu, Z., Dong, S., Zhong, S., et al.[2023]

Transcutaneous spinal direct current stimulation (tsDCS) has been shown to have dose-dependent effects on spinal and cortical excitability in healthy subjects, indicating its potential for modulating neural activity.

In a study involving nine healthy participants, both anodal and cathodal tsDCS demonstrated significant effects on motor evoked potentials and spinal cord excitability, suggesting that further research with larger samples could expand treatment options for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response relationship of transcutaneous spinal direct current stimulation in healthy humans: A proof of concept study. Powell, ES., Korupolu, R., Westgate, PM., et al.[2019]

In a double-blinded study involving 2 male patients with incomplete spinal cord injury, anodal transcutaneous spinal direct current stimulation (tsDCS) improved all measured outcomes, including gait and balance, while cathodal tsDCS showed mixed results.

Both types of tsDCS were able to modulate corticospinal excitability, indicating that this non-invasive method could be a promising approach for enhancing rehabilitation in patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. Abualait, TS., Ibrahim, AI.[2021]

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 Spinal Cord Neuromodulation (SCONE™) showed acute improvements in postural and locomotor abilities in 11 out of 12 individuals with cerebral palsy, including significant advancements in a 2-year-old who was previously unable to step.

The therapy enhanced coordination of muscle movements and joint angles during stepping, suggesting that spinal neuromodulation can lead to beneficial reorganization of spinal-supraspinal connectivity, potentially improving locomotion in patients with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Neuromodulation Reorganizes Neural Networks in Patients with Cerebral Palsy. Gad, P., Hastings, S., Zhong, H., et al.[2023]

Spinal cord stimulation is a safe and reversible treatment option for pain management, making it a preferred choice when less invasive treatments are ineffective.

This method has no reported long-term side effects, highlighting its suitability as a first-line therapy for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: patient selection, technique, and outcomes. Oakley, JC.[2019]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

Trans-spinal direct current stimulation (tsDCS) has shown potential benefits, such as reducing hypertonia and neuropathic pain, particularly with anodal stimulation in patients with central nervous system diseases, based on a review of 8 studies involving 143 subjects.

The application of tsDCS was found to be feasible and safe, with no severe adverse effects reported, although the overall effectiveness remains uncertain due to variability in study results and the need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. Fernández-Pérez, JJ., Serrano-Muñoz, D., Beltran-Alacreu, H., et al.[2023]

A novel non-invasive technique called painless transcutaneous electrical enabling motor control (pcEmc) can effectively stimulate spinal cord circuits to facilitate stepping movements in healthy individuals, showing promise for neuromodulation.

When combined with exoskeleton technology, pcEmc has demonstrated effectiveness in improving motor function in paralyzed patients with spinal cord injuries, highlighting its potential for rehabilitation and understanding locomotion mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical spinal-cord stimulation in humans. Gerasimenko, Y., Gorodnichev, R., Moshonkina, T., et al.[2018]

References

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

The effect of combined transcranial pulsed current stimulation and transcutaneous electrical nerve stimulation on lower limb spasticity in children with spastic cerebral palsy: a randomized and controlled clinical study. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Dose-response relationship of transcutaneous spinal direct current stimulation in healthy humans: A proof of concept study. [2019]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Spinal direct current stimulation with locomotor training in chronic spinal cord injury. [2021]

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

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

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

Transcutaneous Spinal Neuromodulation Reorganizes Neural Networks in Patients with Cerebral Palsy. [2023]

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

Spinal cord stimulation: patient selection, technique, and outcomes. [2019]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

Trans-Spinal Direct Current Stimulation in Neurological Disorders: A systematic review. [2023]

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

Transcutaneous electrical spinal-cord stimulation in humans. [2018]