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.
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.
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.
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%).
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.
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.
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.
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.
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.
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.
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.
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.
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.