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

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.

Study Overview

• Status: Completed
• Conditions: Microcephaly; Global Developmental Delay; Hyperkinesis With Developmental Delay
• Intervention / Treatment: Behavioral: Acquire Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Fralin Biomedical Research Institute at Virginia Tech

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Intervention; All children will receive 3-5 weeks of intensive neuromotor Acquire therapy, an operant conditioning, play based therapy that maximizes therapeutic movements, attention, and engagement.	Behavioral: Acquire Therapy; This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Change from baseline on fMRI measures of connectivity	fMRI data will be probed for change from baseline on measures of connectivity.	5-12 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Virginia Polytechnic Institute and State University
• Collaborators: American Academy for Cerebral Palsy and Developmental Medicine
• Investigators: Principal Investigator: Stephanie C DeLuca, PhD, Virginia Polytechnic Institute and State University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): August 11, 2022

Study Registration Dates

• First Submitted: January 22, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Neurorehabilitation; Global Developmental Delay; Microcephaly; Hyperkinesis; Intensive Interventions
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Congenital Abnormalities; Musculoskeletal Diseases; Dyskinesias; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Microcephaly; Hyperkinesis
• Other Study ID Numbers: IRB #18-490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No