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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation affects the brain and spine in people with cerebral palsy (CP). Researchers aim to determine if this treatment, known as Transcutaneous Current Stimulation (a form of non-invasive neuromodulation), can alter brain and spinal cord activity to potentially improve movement and coordination. The trial welcomes participants with CP and those without neurodevelopmental conditions. Participants with CP should experience movement or coordination difficulties impacting their daily lives. As an unphased trial, this study provides participants the opportunity to contribute to groundbreaking research that could enhance future treatments for 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.

What prior data suggests that this electrical stimulation is safe for cerebral palsy?

Research has shown that electrical stimulation on the skin is generally safe. One study examined this stimulation combined with movement-based therapy and found no serious side effects, indicating its safety. Another study tested non-surgical spinal cord stimulation on individuals with spinal cord injuries and also found no major negative effects. These findings suggest that this type of electrical stimulation is safe for people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cerebral palsy, which often focus on physical therapy, medications like muscle relaxants, or surgeries to manage symptoms, transcutaneous current stimulation offers a non-invasive approach that directly targets neural pathways. This treatment is unique because it uses electrical currents applied through the skin to potentially enhance the brain and spinal cord's communication with muscles, improving motor function. Researchers are excited about this technique because it might strengthen the connections between the brain's motor cortex and the spinal cord, offering a new way to address the root causes of movement difficulties in cerebral palsy rather than just the symptoms.

What evidence suggests that transcutaneous current stimulation is effective for cerebral palsy?

Research has shown that using electrical currents on the skin, known as transcutaneous current stimulation, can improve movement in people with cerebral palsy (CP). One study demonstrated a 14.2-point improvement in movement for a person with CP after eight weeks of this therapy. This trial will compare the effects of transcutaneous current stimulation on two groups: individuals with CP and neurotypical individuals. Other studies suggest that this stimulation can alter brain pathways, potentially enhancing movement control. While the results are promising, further research is needed to understand the long-term benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8608961/

Transcutaneous Spinal Neuromodulation Reorganizes Neural ... This study reports the acute effects of Transcutaneous Electrical Spinal Cord Neuromodulation (SCONE™, SpineX Inc.) on 12 individuals (ages 2 to ...

2. nature.com nature.com/articles/s41467-022-33208-w

A pilot study combining noninvasive spinal ... While these methods may provide a short-term reduction in spasticity, in the long term, they may negatively impact functional changes, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1094715924001119

Non-invasive Transcutaneous Spinal Cord Stimulation ... This study analyzes the stimulation parameters implemented during two successful trials that used non-invasive transcutaneous spinal cord stimulation (tSCS)

4. bioelecmed.biomedcentral.com bioelecmed.biomedcentral.com/articles/10.1186/s42234-023-00133-2

noninvasive spinal neuromodulation improves motor function ... A 60-year-old CP participant underwent 8 weeks of SCiP™ therapy, resulting in significant motor recovery measured by 14.2-points increase in ...

5. withpower.com withpower.com/trial/phase-cerebral-palsy-2024-a25d8

Electrical Stimulation 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9936896/

Transcutaneous Spinal Stimulation From Adults to Children The CPG can be activated by epidural stimulation (EP) and induce the rhythmic stepping-like movements in persons with motor complete spinal cord injury (SCI).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06587841

Noninvasive Spinal Cord Stimulation for Early SCI The purpose of this clinical study is to investigate the safety and effectiveness of non-surgical transcutaneous spinal cord stimulation (TSCS) in helping with ...

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

Safety and Effectiveness of Multisite Transcutaneous ... Objective. Evaluate the preliminary safety and efficacy of multi-site transcutaneous spinal cord stimulation (tSCS) combined with activity-based therapy (ABT) ...

9. neuromodulationjournal.org neuromodulationjournal.org/article/S1094-7159(23)00648-7/fulltext

Safety and Feasibility of Cervical and Thoracic ... To our knowledge, there is no study that has reported safety and feasibility of cervical scTS applied to improve UE motor function in children ...