Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay

Microcephaly Clinical Trial

Official title:

Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816175
• Other study ID #: IRB #18-490
• Status: Completed
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: August 11, 2022

Study information

• Verified date: October 2022
• Source: Virginia Polytechnic Institute and State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: August 11, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Global Developmental Delay
• Hyperkinesis
• Hyperkinesis With Developmental Delay
• Microcephaly

Intervention

Behavioral:
• Acquire Therapy
This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function

Locations

Country	Name	City	State
United States	Fralin Biomedical Research Institute at Virginia Tech	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Polytechnic Institute and State University	American Academy for Cerebral Palsy and Developmental Medicine

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline on Motor Function Assessment	A validated motor function assessment tool the CanChild Gross Motor Function Measure -88 will be used to measure change on motor function. The child can score between 0 and 264 points. The higher the child's score the more tasks they were able to attempt and/or complete.	5-12 weeks
Secondary	Change from baseline on measure of EEG coherence in alpha band	EEG data will be analyzed for changes in coherence in alpha band. Pre and post coherence in alpha band will be probed for changes by electrode pair.	5-12 weeks
Secondary	Change from baseline on measure of EEG coherence in theta band.	EEG data will be analyzed for changes in coherence in theta band. Pre and post coherence in theta band will be probed for changes by electrode pair.	5-12 weeks
Secondary	Change from baseline on measure of EEG coherence in beta band.	EEG data will be analyzed for changes in coherence in beta band. Pre and post coherence in beta band will be probed for changes by electrode pair.	5-12 weeks
Secondary	Change from baseline on measure of EEG coherence in delta band.	EEG data will be analyzed for changes in coherence in delta band. Pre and post coherence in delta band will be probed for changes by electrode pair.	5-12 weeks
Secondary	Change from baseline on EEG power in alpha band.	EEG data will be analyzed for changes in power in alpha band. Pre and post power will be compared for alpha band.	5-12 weeks
Secondary	Change from baseline on EEG power in beta band.	EEG data will be analyzed for changes in power in beta bands. Pre and post power will be compared for beta band.	5-12 weeks
Secondary	Change from baseline on EEG power in theta band.	EEG data will be analyzed for changes in power in theta band. Pre and post power will be compared for theta band.	5-12 weeks
Secondary	Change from baseline on EEG power in delta bands.	EEG data will be analyzed for changes in power in delta bands. Pre and post power will be compared for delta band.	5-12 weeks
Secondary	Change from baseline on Disability Assessment	Using the Pediatric evaluation of disability inventory with scores ranging from 0-100 with higher scored indicating greater functionality.	5-12 weeks
Secondary	Change from baseline on fMRI measures of connectivity	fMRI data will be probed for change from baseline on measures of connectivity.	5-12 weeks
Secondary	Change from baseline on fMRI regional activation patterns.	fMRI data will be probed for change from baseline on measures of regional activation.	5-12 weeks
Secondary	Change from baseline on Motor Assessment	Using the Peabody Developmental Motor Scales, the Peabody consists of 6 subtests, that are each completed according to the child's age as a starting point. If a child were to complete all 6 subtests, and were to start at the earliest age block for all subtests the child would complete 255 items, with scores ranging from 0-510, the higher the score the more tasks the child was able to complete.	5-12 weeks
Secondary	Change from baseline on goal specific assessment	Using a goal specific assessment form developed in the neuromotor research clinic children will be assessed for changes on child specific goals using a metric goal attainment assessment method (See Mann, J 2020 Dev Neurorehab). The child will be measured on their percent change on child-specific goals, with ranges from 0 percent change to infinity percent change. The higher the percent change the more the child changed on that particular goal.	5-12 weeks