Brain Characteristics Noted Prior to and Following Treatment

Brain Characteristics Noted Prior to and Following Treatment of Deformational Plagiocephaly With a Helmet

This study will enable investigators to find out if brain structure and characteristics are affected by the shape of the infant's head, and if changes in the brain occur with helmet therapy.

Study Overview

• Status: Completed
• Conditions: Nonsynostotic Plagiocephaly
• Intervention / Treatment: Other: Non-interventional

Detailed Description

A dramatic increase in the number of infants diagnosed with Deformational Plagiocephaly (DP) has been observed worldwide since institution of the American Academy of Pediatrics' Back to Sleep Program. According to one published report, the incidence of DP ranges between 3-48%; this translates into120,000-2 million infants/year who develop DP in the United States alone. Some healthcare providers believe that DP is a purely cosmetic condition. This mindset undermines the importance of prevention and correction. In New Zealand, a recent study demonstrated that 39% of children without corrective action had persistent DP at age 3 to 4 years. Additionally, several studies have demonstrated associations between impaired social interactions, developmental problems and DP.Thus some researchers now believe that there may be a spectrum of untoward outcomes from brain remodeling resulting from DP. Recent technological advances now allow the detection of diminutive changes in brain structure. In this multidisciplinary descriptive pilot study we will use brain MRI (Magnetic Resonance Imaging) and a cerebral tissue oxygenation monitor, namely Frequency Domain Near Infrared and Diffuse Correlation Spectroscopy (FDNIR/DCS) to describe if differences in brain structure and characteristics exist in infants with significant DP before and after correction of the deformational defect. This study will enable investigators to seek preliminary evidence that brain development is influenced by the shape of the cranial vault, and that changes in brain structure and characteristics occur with helmet therapy. Additionally this study will help to determine the need for a larger investigation of this phenomenon that would further establish an association between DP and developmental delay.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Deformational Plagiocephaly in full term, healthy infants.

Description

Inclusion Criteria:

1. - DP requiring helmet therapy
2. -Term gestation at birth (37 weeks or greater)
3. -Less than/or equal to 8 months of age
4. -No history of major health problem such as birth injury, genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
5. -No history of implantable metal device or internal/external orthotic device

Exclusion Criteria:

1. - DP not requiring helmet therapy
2. -Premature gestation at birth (less than 37 weeks gestation).
3. -Greater than 8 months of age
4. -History of major health problem such as birth injury genetic disorder, intracranial hemorrhage, hydrocephalus, neurologic abnormality
5. -History of implantable metal device or internal/external orthotic device
6. -Infants not completing prescribed treatment for correction with a helmet

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm; Non-interventional; A convenience sample of 10-15 infants born at term gestation, that are </= 6 months of age with significant DP (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study	Other: Non-interventional; Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Qualitatively Determined Normalization of White Matter Pathways	We will compare if nerve pathways are appreciably different in the area of head flattening following helmet therapy by visual examination and comparison of areas of asymmetry vs. symmetry.	2-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improved Developmental Exams Post Helmet Therapy	The Mullen (Scales of Early Learning) was used to determine developmental scores. This tool provides a profile of cognitive ability in five areas: Gross Motor, Fine Motor, Expressive Language, Receptive Language, and Visual Reception. Each of the 5 assessment that has a raw score that is then given a percentile rank and descriptive category (below average, average, above average) for interpretation purposes. Descriptive categories pre treatment were compared to post treatment to determine if scores had improved.	2-6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment	Cranial asymmetry was assessed using the Cranial Vault Asymmetry Index (CVAI). MRI's were utilized to determine CVAI. Asymmetry pre treatment was compared to post treatment to see if asymmetry improved.	Collected retrospectively

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Michele DeGrazia, PhD, RN, NNP, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Plagiocephaly
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly; Plagiocephaly, Nonsynostotic
• Other Study ID Numbers: IRB-P00004233