What is the mechanism of action of this treatment?

The I-ACQUIRE trial focuses on intensive infant rehabilitation techniques for treating Perinatal Arterial Stroke (PAS). These rehabilitation techniques primarily aim to enhance neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for infants with PAS as it can help compensate for the damaged areas of the brain, thereby improving motor and cognitive functions. Early and intensive rehabilitation can lead to better long-term outcomes by maximizing the potential for recovery during a critical period of brain development.

What side effects are associated with this type of intervention?

Rehabilitation techniques for infants with perinatal arterial stroke, such as those studied in the I-ACQUIRE trial, generally focus on improving motor and cognitive outcomes. Common side effects of intensive rehabilitation can include temporary fatigue, irritability, and muscle soreness. However, these side effects are typically mild and transient. It is important for caregivers and healthcare providers to monitor infants closely to ensure that the intensity of therapy is appropriate and to adjust as needed to minimize discomfort.

What prior FDA approvals exist?

There is limited specific information on FDA-approved drugs for the treatment of Perinatal Stroke. However, the I-ACQUIRE trial focuses on intensive infant rehabilitation protocols, which are non-pharmacological interventions aimed at improving motor function in infants who have experienced Perinatal Arterial Stroke. These rehabilitation techniques are designed to enhance neuroplasticity and functional recovery, rather than relying on drug treatments. Therefore, the primary focus for treating Perinatal Stroke in this context is on specialized rehabilitation programs rather than FDA-approved medications.

What other types of research exist?

Promising alternatives to I-ACQUIRE for infants with Perinatal Arterial Stroke include early intervention with neuroprotective agents such as magnesium sulfate, which has shown efficacy in reducing cerebral palsy and severe motor dysfunction. Additionally, constraint-induced movement therapy (CIMT) has demonstrated improved arm and hand use in children with hemiplegic cerebral palsy and could be adapted for perinatal stroke rehabilitation. Advances in motor interventions and the use of big data to tailor individualized rehabilitation plans are also emerging as potential alternatives.

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Intensive Infant Rehabilitation for Perinatal Stroke (I-ACQUIRE Trial)

Phase 3

Waitlist Available

Led By Sharon L Ramey, Ph.D.

Research Sponsored by Virginia Polytechnic Institute and State University

Eligibility Criteria Checklist

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

Must have

Child has hemiparesis

Child has a diagnosis of Perinatal Arterial Stroke (PAS)

Must not have

Child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT with a dose of at least 2 hrs/day for ≥10 days

Child has medical or sensory condition(s) that prevent(s) full therapy participation (e.g., frequent uncontrolled seizures, fragile health)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new therapy program called I-ACQUIRE for infants who have had a stroke. The program involves intensive sessions with therapists to help improve movement and strength. The study will compare two different amounts of therapy to usual treatments to see which works best.

Who is the study for?

This trial is for infants aged 8-36 months who have had a Perinatal Arterial Stroke, resulting in hemiparesis. They must not have received certain previous treatments like high-dose movement therapy or botulinum toxin within the last three months. One parent must be English-speaking to interact with study staff and manage home therapy.

What is being tested?

The trial tests two different doses of a new infant rehabilitation protocol called I-ACQUIRE against standard rehab methods for babies who've had strokes. It aims to see which dosage improves motor skills better.

What are the potential side effects?

Since this is an intensive rehabilitation program rather than a drug treatment, side effects may include fatigue or frustration during exercises, but specific side effects will depend on the child's individual response to therapy.

Eligibility Criteria

Inclusion Criteria

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

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My child has weakness on one side of their body.

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My child was diagnosed with a stroke that occurred around the time of birth.

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My parent(s) agree to be part of the home therapy.

Exclusion Criteria

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

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My child has undergone intensive movement therapy for at least 2 hours a day over 10 days.

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My child's health condition prevents them from fully participating in therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Emerging Behaviors Scale (EBS) Score

Secondary study objectives

Hand

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: I-ACQUIRE Moderate DoseExperimental Treatment1 Intervention

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Group II: I-ACQUIRE High DoseExperimental Treatment1 Intervention

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Group III: Usual & Customary TreatmentActive Control1 Intervention

Usual \& Customary Treatment

0 / 5Eligibility 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

The I-ACQUIRE trial focuses on intensive infant rehabilitation techniques for treating Perinatal Arterial Stroke (PAS). These rehabilitation techniques primarily aim to enhance neuroplasticity, which is the brain's ability to reorganize itself by forming new neural connections. This is crucial for infants with PAS as it can help compensate for the damaged areas of the brain, thereby improving motor and cognitive functions. Early and intensive rehabilitation can lead to better long-term outcomes by maximizing the potential for recovery during a critical period of brain development.

Drug therapy in hypoxic-ischemic cerebral insults and intraventricular hemorrhage of the newborn.Effect of single family rooms for preterm infants on neurodevelopment: study protocol for a systematic review.Therapeutic Hypothermia: How Can We Optimize This Therapy to Further Improve Outcomes?