Clinical trial NCT04816175: Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
Official title: Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microcephaly
Hyperkinesis With Developmental Delay
Global Developmental Delay
Keywords: Global Developmental Delay
Hyperkinesis
Microcephaly
Neurorehabilitation
Intensive Interventions
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
Collaborators: name: American Academy of Cerebral Palsy and Developmental Medicine
First posted: 2021-03-25
Enrollment: 4
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: As an early phase study, all enrolled children will receive the intervention.
Primary purpose: TREATMENT

Brief summary: This trial will consist of a clinical series of up to 50 children with Global Developmental Delay and concomitant microcephaly or hyperkinetic movements. All children will be assessed for psychomotor function using standardized assessments, goal specific assessments, with the potential addition of neuroimaging assessment, prior to and after receiving an intensive burst of neuromotor therapy. The interventional effects will be explored by comparing the pre and post interventional assessments and neuroimaging.

Detailed description: Up to 50 children between the ages of 6 months and 15 years will be recruited to participate in a burst of intensive neuromotor intervention in the form of Acquire therapy, delivered by the treatment team at Virginia Tech's Neuromotor Research Clinic. All children will have a diagnosis of Global Developmental Delay, with concomitant microcephaly or hyperkinetic movements. The children will be assessed for psychomotor function prior to and after the treatment intervention, using a series of standardized and goal specific assessments, with the possibility of additional neuroimaging assessments when possible. Acquire therapy is an intensive intervention in that it is delivered with high intensity, wherein goal directed behaviors are promoted at high levels of repetition and delivered at a high dose (4-6 hours a day) in an intensive burst of 3-4 weeks of 5 day a week treatment. Acquire therapy is an operant conditioning based intervention delivered in a cycle of refinement, reinforcement and repetition. It is play-based with activities selected to drive behavior toward goals that are specific to each child and selected based on each child's interests and needs. As such a specific protocol cannot be outlined. However, all goal directed activities are designed to promote awareness of and engagement with others and the environment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.

Exclusion Criteria:

* Medical Instability
* Under 6 months of age over 15 years of age

Primary outcomes:
measure: Change from baseline on Motor Function Assessment
timeFrame: 5-12 weeks
Secondary outcomes:
measure: Change from baseline on measure of EEG coherence in alpha band
timeFrame: 5-12 weeks
measure: Change from baseline on measure of EEG coherence in theta band.
timeFrame: 5-12 weeks
measure: Change from baseline on measure of EEG coherence in beta band.
timeFrame: 5-12 weeks
measure: Change from baseline on measure of EEG coherence in delta band.
timeFrame: 5-12 weeks
measure: Change from baseline on EEG power in alpha band.
timeFrame: 5-12 weeks
measure: Change from baseline on EEG power in beta band.
timeFrame: 5-12 weeks
measure: Change from baseline on EEG power in theta band.
timeFrame: 5-12 weeks
measure: Change from baseline on EEG power in delta bands.
timeFrame: 5-12 weeks
measure: Change from baseline on Disability Assessment
timeFrame: 5-12 weeks
measure: Change from baseline on fMRI measures of connectivity
timeFrame: 5-12 weeks
measure: Change from baseline on fMRI regional activation patterns.
timeFrame: 5-12 weeks
measure: Change from baseline on Motor Assessment
timeFrame: 5-12 weeks
measure: Change from baseline on goal specific assessment
timeFrame: 5-12 weeks
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Fralin Biomedical Research Institute at Virginia Tech
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Stephanie C DeLuca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeLuca SC, Wallace DA, Trucks MR, Mukherjee K. A clinical series using intensive neurorehabilitation to promote functional motor and cognitive skills in three girls with CASK mutation. BMC Res Notes. 2017 Dec 19;10(1):743. doi: 10.1186/s13104-017-3065-z.
citation: Mann J, Wallace DA, DeLuca S. Case study on the use of intensive pediatric neurorehabilitation in the treatment of kernicterus. J Clin Mov Disord. 2020 Feb 3;7:1. doi: 10.1186/s40734-020-0084-z. eCollection 2020.
citation: Ramey SL, DeLuca S, Stevenson RD, Case-Smith J, Darragh A, Conaway M. Children with Hemiparesis Arm and Movement Project (CHAMP): protocol for a multisite comparative efficacy trial of paediatric constraint-induced movement therapy (CIMT) testing effects of dosage and type of constraint for children with hemiparetic cerebral palsy. BMJ Open. 2019 Jan 15;9(1):e023285. doi: 10.1136/bmjopen-2018-023285.