Electrical Stimulation for Cerebral Palsy

(CP Trial)

Overseen By Ahad Behboodi, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must not be taking: Botulinum injections

Disqualifiers: Athetoid CP, Ataxic CP, others

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

Compensation: Varies

Number of Visits: 2

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 does mention 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 NMES for cerebral palsy?

Research shows that neuromuscular electrical stimulation (NMES) can help improve movement and walking ability in children with cerebral palsy. Studies found that children using NMES showed better motor function and increased muscle efficiency, suggesting it can be a useful addition to physical therapy. ^{1 2 3 4 5}

Is neuromuscular electrical stimulation (NMES) safe for use in humans?

NMES has been used for many years in conditions like cerebral palsy and stroke, with studies showing it can improve muscle function and mobility. While there is limited information on major adverse events, patient tolerability and precise timing of stimulation are important considerations for safety. ^{4 5 6 7 8}

How does the treatment NMES differ from other treatments for cerebral palsy?

NMES (Neuromuscular Electrical Stimulation) is unique because it uses electrical impulses to stimulate muscles, potentially improving muscle strength, reducing spasticity (muscle stiffness), and enhancing motor skills in children with cerebral palsy. Unlike traditional physical therapy, NMES can be precisely timed to assist with specific movements, such as walking, and may offer benefits when used alongside other therapies. ^{1 4 5 7 9}

What is the purpose of this trial?

The goal of this study is to see if gentle electrical stimulation can help children with cerebral palsy (CP) walk more easily. This stimulation, called neuromuscular electrical stimulation (NMES), sends small pulses to the muscles to help them activate. Researchers will test different ways of using NMES to find out which method works best. Participants will walk on a treadmill at a comfortable speed while NMES is applied to leg muscles. The study will compare different stimulation settings to see which one helps the most.

Research Team

Ahad Behboodi, PhD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for children with cerebral palsy who can walk on a treadmill. Specific eligibility criteria are not provided, but typically participants must be in stable health and able to comply with study requirements.

Inclusion Criteria

I do not have conditions like severe scoliosis or hip problems.

I can travel to the University of Nebraska at Omaha twice.

My seizures are well-controlled or I don't have seizures.

Exclusion Criteria

I have been diagnosed with athetoid or ataxic cerebral palsy.

My main scoliosis curve is over 49 degrees.

I have severe joint movement limitations or muscle tightness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Assessment

Participants undergo two assessment sessions with NMES applied to leg muscles while walking on a treadmill

3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• NMES

Trial Overview The trial is testing neuromuscular electrical stimulation (NMES) applied to leg muscles while walking on a treadmill. It aims to find the best NMES settings that improve walking ability in children with cerebral palsy.

Participant Groups

Group I: CP group Experimental Treatment 1 Intervention

The intervention group, CP group, will receive a low power electrical stimulation on different combination of their lower limb muscles while walking on the treadmill.

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

References

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

Clinical use of neuromuscular electrical stimulation for children with cerebral palsy, Part 1: Lower extremity. [2019]

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

The effects of a neuromuscular electrical stimulation home program on impairments and functional skills of a child with spastic diplegic cerebral palsy: a case report. [2006]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Wide-pulse-high-frequency neuromuscular electrical stimulation in cerebral palsy. [2017]

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

Neuromuscular electrical stimulation versus volitional isometric strength training in children with spastic diplegic cerebral palsy: a preliminary study. [2018]

5. Brazil pubmed.ncbi.nlm.nih.gov

Neuromuscular electrical stimulation to improve gross motor function in children with cerebral palsy: a meta-analysis. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

A Scoping Review of Neuromuscular Electrical Stimulation to Improve Gait in Cerebral Palsy: The Arc of Progress and Future Strategies. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Toward a hybrid exoskeleton for crouch gait in children with cerebral palsy: neuromuscular electrical stimulation for improved knee extension. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide. [2020]

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

Clinical use of neuromuscular electrical stimulation for children with cerebral palsy, Part 2: Upper extremity. [2019]