CompletedNot Applicable

Brain Characteristics Noted Prior to and Following Treatment

United States10 participantsStarted 2013-02

Plain-language summary

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.

Who can participate

Age range8 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Number of Participants With Qualitatively Determined Normalization of White Matter Pathways

Timeframe: 2-6 months

Trial details

NCT IDNCT02392195

SponsorBoston Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-09

Results submitted2020-09-23

View on ClinicalTrials.gov More Nonsynostotic Plagiocephaly trials