What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy (CP) that aim to improve gait and muscle function include physical and occupational therapy, pharmacologic treatments, and surgical interventions. Physical and occupational therapies are generally safe but can sometimes cause temporary muscle soreness or fatigue. Pharmacologic treatments, such as botulinum toxin injections, can lead to side effects like muscle weakness, pain at the injection site, and, rarely, systemic effects like difficulty swallowing or breathing. Surgical interventions, such as tendon lengthening or selective dorsal rhizotomy, carry risks of infection, bleeding, and prolonged recovery periods. Devices like the wearable leg sleeve, which aim to correct muscle signals, are still under study, but potential side effects could include skin irritation, discomfort, or muscle fatigue from prolonged use.

What prior FDA approvals exist?

The FDA has approved several treatments for managing symptoms of Cerebral Palsy, particularly those aimed at improving gait and muscle function. Oral antispasticity medications such as baclofen and benzodiazepines are commonly used to manage spasticity in CP patients. Botulinum toxin injections (e.g., onabotulinumtoxinA) are also approved for localized spasticity treatment. Additionally, intrathecal baclofen pumps are used for severe spasticity. While specific devices like the wearable leg sleeve are still under investigation, other assistive devices such as orthotics and adaptive strollers are widely used to aid mobility in CP patients.

What other types of research exist?

Promising, novel alternatives to the Wearable Leg Sleeve for improving gait in Cerebral Palsy patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in modulating brain activity to improve motor function; 2) Mind-body therapies such as yoga and Qigong massage, which can enhance sensory processing and self-regulation; and 3) Neurofeedback, which uses real-time monitoring of brain activity to train patients to improve motor control.

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Wearable Leg Sleeve for Cerebral Palsy

N/A

Waitlist Available

Led By Rachel Thompson

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 to 2 hours for follow-up clinical visit

Awards & highlights

Summary

This trial tests a wearable leg sleeve called the Cionic Neural Sleeve, which helps children with cerebral palsy walk better. It measures muscle activity and leg movements, then sends signals to correct these movements. The device uses small electrical charges to stimulate muscles, making walking smoother and easier.

Who is the study for?

This trial is for children aged 8-14 with spastic cerebral palsy affecting their legs, who can sit, stand, and walk at least 50 feet independently or with help. They must understand English and be accompanied by a parent/guardian. It's not for those with other neurological diseases, lower limb skin conditions, latex allergies, cognitive impairments that prevent following instructions, or certain movement disorders.

What is being tested?

The study tests the Cionic Neural Sleeve NS-100 on kids with CP to see if it helps them walk better. Participants will wear the sleeve during a visit to Kameron Gait and Motion Analysis Center where their walking patterns are analyzed before and after using the device in 'corrective mode' which stimulates muscles to improve gait.

What are the potential side effects?

While specific side effects aren't detailed here as it's a non-drug device being tested; potential risks may include discomfort from wearing the sleeve or skin irritation from electrode placement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 to 2 hours for follow-up clinical visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 to 2 hours for follow-up clinical visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 to 2 hours for follow-up clinical visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neuromodulation activity (motor unit potential)

Range of motion (degrees) in lower extremities

Secondary study objectives

Patient-reported physical function (PROMIS score)

Trial Design

2Treatment groups

Active Control

Group I: Patient with Cerebral Palsy, no interventionActive Control1 Intervention

Gait analysis of cerebral palsy patients without any intervention.

Group II: Patient with Cerebral Palsy, with sleeveActive Control1 Intervention

Gait analysis of cerebral palsy patients while wearing neural sleeve.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cerebral Palsy (CP) focus on improving motor function and gait. Physical and occupational therapy enhance muscle strength and coordination through repetitive tasks and exercises. Botulinum toxin injections reduce spasticity by blocking nerve signals to overactive muscles, improving range of motion and ease of movement. Selective dorsal rhizotomy (SDR) involves cutting nerve roots in the spinal cord to reduce spasticity and improve motor function. These treatments are crucial for CP patients as they address muscle control and coordination issues, enhancing mobility, independence, and quality of life.

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Who is running the clinical trial?

Cionic, Inc.Industry Sponsor

4 Previous Clinical Trials

122 Total Patients Enrolled

University of California, Los AngelesLead Sponsor

1,554 Previous Clinical Trials

10,264,114 Total Patients Enrolled

2 Trials studying Cerebral Palsy

124 Patients Enrolled for Cerebral Palsy

Rachel ThompsonPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Patient with Cerebral Palsy, with sleeve Clinical Trial Eligibility Overview. Trial Name: NCT05660096 — N/A

Cerebral Palsy Research Study Groups: Patient with Cerebral Palsy, no intervention, Patient with Cerebral Palsy, with sleeve

Cerebral Palsy Clinical Trial 2023: Patient with Cerebral Palsy, with sleeve Highlights & Side Effects. Trial Name: NCT05660096 — N/A

Patient with Cerebral Palsy, with sleeve 2023 Treatment Timeline for Medical Study. Trial Name: NCT05660096 — N/A

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