Clinical trial NCT03595033: Hydrocephalus iPad-App Based Intervention Study
Official title: iPad Application Based Therapy Intervention in School Age Children With Surgically Treated Hydrocephalus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hydrocephalus
Hydrocephaly
Hydrocephalus in Children
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study examining the feasibility and efficacy of using Apple iPad applications ("apps") during therapy interventions that target visual motor, visual attention, and visual-spatial reasoning skills in school age children who were previously treated surgically for hydrocephalus. Each subject will participate in an initial assessment and baseline MRI, followed by 6-weeks of iPad app-based interventions, and finally a follow-up assessment and a follow-up MRI.

Detailed description: Long term visuospatial and visuomotor functional deficits are common in pediatric patients with surgically treated hydrocephalus. The deficits are often mild/moderate at early school age although the gap may widen as the children grow older, leading to increasing adverse impact on school performance and academic achievement. The proposed study will generate initial pilot data for the usage of iPad application based therapy intervention for the treatment of cognitive deficits common to pediatric hydrocephalus. It will help determine the optimal intensity and duration of training protocol adapted for the study. In addition, the sensitivity of neuroimaging (DTI) in response to the therapy will be assessed and validated as a biomarker that reflects the neuroanatomical alterations underpinning the outcome changes. This study will generate the crucial data to support the design of future Phase III clinical trial with the long term goal as changing the current standard of care in order to prevent neurocognitive and sensorimotor deficits before the injury to neural circuitry becomes irreversible.

The participants who meet the inclusion criteria and do not opt-out of participation will be called by a study coordinator to ensure eligibility and to schedule the initial assessment date. Participation in this study will include 8-10 study visits. These visits include 2 neuropsychological assessments, 2 MRI visits, and 6 weekly visits during intervention phase. MRI visit can be combined with the neuropsychological assessment visit if possible at both the pre- and post intervention time points.

Eligibility criteria: Inclusion Criteria:

* Children, aged 6 to 17 years, with hydrocephalus who have had a surgical intervention
* Deficits in 2 of more of the following neuropsychological testing categories: visual motor, visual attention, or visual reasoning.

Exclusion Criteria:

* Shunt revision within the past one year
* MRI-sensitive programmable shunt or any other MRI-sensitive implant
* Braces or other dental hardware that would interfere with the quality of MRI images (participants with braces are only excluded from the MRI portion of the study)
* Intellectual disability: IQ \< 70
* Deficits in one or none of the three following neuropsychological testing categories: visual motor, visual attention, or visual reasoning
* Age 18 years or greater
* Non-English speaking: We will not enroll non-English speaking participants because the iPad applications are not readily available in other languages. All neuropsychological testing materials are also in English.

Primary outcomes:
measure: General intellectual functioning, including visual-spatial reasoning
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Basic visual perception, visual-motor integration, and graphomotor skills
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Visual-spatial processing
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Visual-spatial processing and mental rotation
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Selective visual attention
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Visual-spatial decision making and visual-motor speed
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Fine motor dexterity
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Visual-motor control
timeFrame: Initial assessment and Follow-up assessment (6-8 weeks after Initial assessment)
measure: Neuroanatomical alterations in brain tissue structure
timeFrame: Baseline MRI and Follow-up MRI (6-8 weeks after Baseline MRI)
Secondary outcomes:
measure: Adherence to the training plan
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Karen L Harpster, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: