Acquire Therapy for Microcephaly

Phase-Based Estimates
1
Effectiveness
1
Safety
Fralin Biomedical Research Institute at Virginia Tech, Roanoke, VA
Microcephaly+3 More
Acquire Therapy - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Microcephaly

Study Summary

This study is evaluating whether intensive therapy may help improve motor function for children with developmental delays.

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Eligible Conditions

  • Microcephaly
  • Hyperkinesis
  • Hyperkinesis With Developmental Delay
  • Global Developmental Delay

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Acquire Therapy will improve 1 primary outcome and 13 secondary outcomes in patients with Microcephaly. Measurement will happen over the course of 5-12 weeks.

5-12 weeks
Change from baseline on Disability Assessment
Change from baseline on EEG power in alpha band.
Change from baseline on EEG power in beta band.
Change from baseline on EEG power in delta bands.
Change from baseline on EEG power in theta band.
Change from baseline on Motor Assessment
Change from baseline on Motor Function Assessment
Change from baseline on fMRI measures of connectivity
Change from baseline on fMRI regional activation patterns.
Change from baseline on goal specific assessment
Change from baseline on measure of EEG coherence in alpha band
Change from baseline on measure of EEG coherence in beta band.
Change from baseline on measure of EEG coherence in delta band.
Change from baseline on measure of EEG coherence in theta band.

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Treatment Intervention

This trial requires 4 total participants across 2 different treatment groups

This trial involves 2 different treatments. Acquire Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Treatment Intervention
Behavioral
All children will receive 3-5 weeks of intensive neuromotor Acquire therapy, an operant conditioning, play based therapy that maximizes therapeutic movements, attention, and engagement.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 5-12 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 5-12 weeks for reporting.

Who is running the study

Principal Investigator
S. D.
Stephanie DeLuca, Principal Investigator
Virginia Polytechnic Institute and State University

Closest Location

Fralin Biomedical Research Institute at Virginia Tech - Roanoke, VA

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is microcephaly?

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Microcephaly is a small or undersized head of an individual and a symptom in some types of primary microcephaly. In contrast, the term microcephaly is also used as a descriptive term for a wide array of neurological disabilities, some of which occur together with microcephaly. The term microcephaly is a misnomer because it does not define any particular condition and is misleading as we know microcephaly can occur without the associated condition of other neurological disabilities, such as intellectual or developmental disabilities or dementia. In summary, when used, the term "microcephaly" is vague and it is not useful in defining any particular condition.

Unverified Answer

How many people get microcephaly a year in the United States?

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1,100 to 2,000 individuals with microcephaly are diagnosed with microcephaly a year in the United States. In a US study, microcephaly was found to be significantly skewed (p = 0.038) more commonly in Caucasians (80.5%), but also, the prevalence of microcephaly is higher in people of Hispanic origin (44.8%).

Unverified Answer

What causes microcephaly?

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MCD is an autosomal dominant genetic disorder associated with chromosome 17q21. The specific genes involved remain unclear and are likely to be located in a non-coding sequence (CNV) of the chromosome. However, there is evidence that a mutation either in or around a gene responsible for myelin synthesis might be the cause of MCD.

Unverified Answer

What are the signs of microcephaly?

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Many children with microcephaly have problems with the development of language, motor skills, and memory. One characteristic of microcephaly is an unusually short head or an unusually large head. Head circumference is a poor marker of brain size; a child with an unusually large head can have a brain smaller than usual size. A child with normal brain size can have a short skull if he or she has been exposed to drugs or syndromes that cause brain damage but cause a short head. It is important to know the different types of macrocephaly (very wide skull, macrocephalic) and microcephaly (wide head, macrocephaly) when assessing a child with brain damage.

Unverified Answer

Can microcephaly be cured?

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Microcephaly is a very rare disorder, but when sporadic it does not seem to be inherited. Because of the low mortality rate, sporadic microcephaly is of low concern.

Unverified Answer

How serious can microcephaly be?

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If the fetus or newborn survives the perinatal period, it is unlikely that the small brain volume can be completely erased. Many neurological events may arise from this tiny brain. These may result in a variety of symptoms, such as mild intellectual disability, hypotonia, mild motor impairment, microcephaly, epilepsy, and schizophrenia as well as severe mental retardation, including autism spectrum disorders, in extreme cases. In the majority of cases, the effects of microcephaly are minimal or totally invisible to the patient or others. In severe cases, some of the symptoms may become very obvious and may not be noticed by other people. Thus a number of patients may just be overlooked or misjudged in some way.

Unverified Answer

Does acquire therapy improve quality of life for those with microcephaly?

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Although an acquired intervention was not effective in improving QOL for most women with MCPH, the results are promising given the need for effective intervention that target the child more directly than the parents.

Unverified Answer

Is acquire therapy safe for people?

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Babies born to women who received IAP for prevention of miscarriage had increased risk of severe congenital malformations compared with historical control for similar IAP exposures. This finding may be due to a biological effect of IAP on fetal membranes, rather than complications with the therapy itself.

Unverified Answer

What is the latest research for microcephaly?

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Microcephaly may be [an evolving disease] because no treatment has been proven to stop its occurrence. The problem may be harder for some babies than others, possibly depending on a particular batch of cells or the location within the developing brain of the damage. The damage to brain cells, which occurs early on, then [continues to grow as the brain matures, and there seems to be nothing which can stop it from destroying the microcephaly cases] as they grow. There are many doctors worldwide trying to develop possible treatments to stop microcephaly. There is a team at the [W.H.O. (World Health Organisation) in Geneva] that has been searching for this problem ever since they observed it.

Unverified Answer

What is acquire therapy?

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Acquire therapy was used the most for patients with moderate or severe symptoms. It was useful on its own in patients with less symptoms or was not indicated in patients who had mild symptoms with the help of other therapy.

Unverified Answer

Is acquire therapy typically used in combination with any other treatments?

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Acquire therapy is commonly used in combination with other treatments for all patients, but the effect of such use is less than has been reported in the literature; therefore, the authors were curious about how commonly such combination therapies are used. The authors used this analysis as an opportunity to encourage health professionals to use acquire therapy as an adjunct to other therapies, as combination therapy may provide additive benefits to patients with CTE.

Unverified Answer
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