Trial Outcomes & Findings for Brain Characteristics Noted Prior to and Following Treatment (NCT NCT02392195)

Last Updated: 2020-12-10

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

2-6 months

Results posted on

2020-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	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 Non-interventional: Observational
Overall Study STARTED	10
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Non-interventional: Observational
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Brain Characteristics Noted Prior to and Following Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm; Non-interventional n=2 Participants A convenience sample of infants born at term gestation, \</= 6 months of age with significant Deformational Plagiocephaly (DP) (defined as head flattening requiring helmet therapy) and no major health issues will be recruited into this phase 1 descriptive pilot study Non-interventional: Observational
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	6 months n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants
Cranial vault asymmetry index (CVAI) > 8.75%	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2-6 months

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.

Outcome measures

Outcome measures
Measure	Single Arm; Non-interventional n=2 Participants A convenience sample of 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 Non-interventional: Observational
Number of Participants With Qualitatively Determined Normalization of White Matter Pathways	2 Participants

SECONDARY outcome

Timeframe: 2-6 months

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.

Outcome measures

Outcome measures
Measure	Single Arm; Non-interventional n=2 Participants A convenience sample of 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 Non-interventional: Observational
Number of Participants With Improved Developmental Exams Post Helmet Therapy	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Collected retrospectively

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.

Outcome measures

Outcome measures
Measure	Single Arm; Non-interventional n=2 Participants A convenience sample of 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 Non-interventional: Observational
Number of Participants With Improved Cranial Asymmetry After Cranial Orthotic Treatment	2 participants

Adverse Events

Single Arm; Non-interventional

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michele DeGrazia

Boston Children's Hospital

Phone: 617-919-1222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place