What is the mechanism of action of this treatment?

Common treatments for Cerebral Palsy (CP) such as Constraint-Induced Movement Therapy (CIMT), Bimanual Therapy, and Botulinum Neurotoxin (BoNT) injections work by enhancing motor function and promoting neuroplasticity. CIMT encourages the use of the affected limb by restraining the unaffected one, thereby improving motor and sensory function. Bimanual Therapy focuses on coordinated use of both hands through structured activities. BoNT injections reduce muscle spasticity by blocking nerve signals, improving range of motion and function. These treatments are vital for CP patients as they enhance neuroplasticity and motor skills, leading to greater independence and better quality of life.

What side effects are associated with this type of intervention?

Common treatments for Cerebral Palsy aimed at enhancing motor function and skill learning include botulinum toxin injections, oral antispasticity medications, and physical therapies such as constraint-induced movement therapy (CIMT) and bimanual training. Botulinum toxin injections can cause side effects like pain at the injection site, muscle weakness, and in rare cases, systemic effects such as difficulty swallowing or breathing. Oral antispasticity medications, including baclofen and benzodiazepines, may lead to drowsiness, fatigue, and in some cases, liver toxicity or dependency. Physical therapies like CIMT and bimanual training are generally safe but can cause temporary discomfort or frustration due to the intensive nature of the exercises.

What prior FDA approvals exist?

FDA-approved treatments for cerebral palsy primarily focus on managing spasticity and improving motor function. These include oral antispasticity medications such as baclofen and benzodiazepines, botulinum toxin injections for localized spasticity, and surgical options like selective dorsal rhizotomy and intrathecal baclofen pumps. While these treatments help manage symptoms and improve quality of life, there is limited information on FDA-approved treatments specifically aimed at enhancing bimanual skill learning and augmenting skill-dependent plasticity, similar to the mechanisms studied in Remote Ischemic Conditioning (RIC).

What other types of research exist?

Promising novel alternatives to Remote Ischemic Conditioning (RIC) for Cerebral Palsy patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown potential in modulating brain activity and enhancing motor function; 2) Music Therapy, which can improve motor and emotional rehabilitation; and 3) Therapeutic Horseback Riding, which has been found to enhance social functioning and motor skills in children with neurodevelopmental disorders.

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Remote Ischemic Conditioning for Cerebral Palsy

N/A

Recruiting

Led By Swati Surkar

Research Sponsored by East Carolina University

Eligibility Criteria Checklist

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

Must have

Manual Ability Classification System (MACS) levels I-III

Children diagnosed with unilateral cerebral palsy, ages 6-16 years

Must not have

Children with metal implants and incompatible medical devices for MRI scans

Children with absent active motor threshold

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 1 week

Summary

This trial tests a new treatment for children with one-sided cerebral palsy. It uses a blood pressure cuff to stop and start blood flow, combined with hand exercises, to help the brain learn new movements better. The goal is to improve hand and arm function in these children.

Who is the study for?

This trial is for children aged 6-16 with unilateral cerebral palsy, who can stack cups and follow instructions. They should be fairly independent in daily tasks (MACS levels I-III) and not have other developmental disabilities, seizures, metal implants, or be on certain medications.

What is being tested?

The study tests if remote ischemic conditioning (RIC), a new method that temporarily restricts blood flow to limbs, can improve hand coordination when combined with intensive bimanual skill training in children with unilateral cerebral palsy.

What are the potential side effects?

Potential side effects of RIC may include discomfort at the site where blood flow is restricted. The intensity of training could lead to muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can use my hands for daily tasks with little to some help.

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My child, aged 6-16, has been diagnosed with unilateral cerebral palsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has metal implants or devices not safe for MRI.

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My child cannot voluntarily move muscles.

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My child has difficulties with thinking or communicating.

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My child has a metabolic disorder, cancer, or water on the brain.

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My child has heart, lung, or blood vessel problems.

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My child has seizures and is taking medication for them.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 week for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Assisting Hand Assessment

Change in Bimanual Task Performance

Change in Resting and Active Motor Thresholds

+1 more

Secondary study objectives

Change in Balance performance

Change in Box and Blocks Test (BBT)

Change in Hand grip and pinch strength

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Remote Ischemic Conditioning (RIC)Experimental Treatment4 Interventions

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training

Group II: Sham ConditioningPlacebo Group4 Interventions

Sham conditioning is achieved via blood pressure cuff inflation to 25 mmHg on the more involved arm. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2-6. Intervention * Hand Arm Bimanual Intensive Therapy (HABIT) * Bimanual cup stacking training * Balance training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remote Ischemic Conditioning (RIC)

2015

Completed Phase 3

~410

Balance training

2014

Completed Phase 1

~820

0 / 8Eligibility criteria met

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) such as Constraint-Induced Movement Therapy (CIMT), Bimanual Therapy, and Botulinum Neurotoxin (BoNT) injections work by enhancing motor function and promoting neuroplasticity. CIMT encourages the use of the affected limb by restraining the unaffected one, thereby improving motor and sensory function. Bimanual Therapy focuses on coordinated use of both hands through structured activities. BoNT injections reduce muscle spasticity by blocking nerve signals, improving range of motion and function. These treatments are vital for CP patients as they enhance neuroplasticity and motor skills, leading to greater independence and better quality of life.

Feasibility of High Repetition Upper Extremity Rehabilitation for Children with Unilateral Cerebral Palsy.The Most Cited Original Articles in Brain Imaging of Children With Cerebral Palsy: A Bibliometric Analysis Between 1984 and 2019.The effects of modified constraint-induced movement therapy combined with intensive bimanual training in children with brachial plexus birth injury: a retrospective data base study.