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

Primary Purpose

Microcephaly, Hyperkinesis With Developmental Delay, Global Developmental Delay

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acquire Therapy
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Microcephaly focused on measuring Global Developmental Delay, Hyperkinesis, Microcephaly, Neurorehabilitation, Intensive Interventions

Eligibility Criteria

6 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fralin Biomedical Research Institute at Virginia Tech

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
Change from baseline on fMRI measures of connectivity
fMRI data will be probed for change from baseline on measures of connectivity.
Change from baseline on fMRI regional activation patterns.
fMRI data will be probed for change from baseline on measures of regional activation.
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.
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.

Full Information

First Posted
January 22, 2021
Last Updated
October 11, 2022
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
American Academy for Cerebral Palsy and Developmental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04816175
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
August 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
American Academy for Cerebral Palsy and Developmental Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microcephaly, Hyperkinesis With Developmental Delay, Global Developmental Delay
Keywords
Global Developmental Delay, Hyperkinesis, Microcephaly, Neurorehabilitation, Intensive Interventions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
As an early phase study, all enrolled children will receive the intervention.
Masking
None (Open Label)
Masking Description
Because all children will receive the intervention all parties involved will be aware that the participant has received the intervention.
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Acquire Therapy
Intervention Description
This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function
Primary Outcome Measure Information:
Title
Change from baseline on Motor Function Assessment
Description
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.
Time Frame
5-12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline on measure of EEG coherence in alpha band
Description
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.
Time Frame
5-12 weeks
Title
Change from baseline on measure of EEG coherence in theta band.
Description
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.
Time Frame
5-12 weeks
Title
Change from baseline on measure of EEG coherence in beta band.
Description
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.
Time Frame
5-12 weeks
Title
Change from baseline on measure of EEG coherence in delta band.
Description
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.
Time Frame
5-12 weeks
Title
Change from baseline on EEG power in alpha band.
Description
EEG data will be analyzed for changes in power in alpha band. Pre and post power will be compared for alpha band.
Time Frame
5-12 weeks
Title
Change from baseline on EEG power in beta band.
Description
EEG data will be analyzed for changes in power in beta bands. Pre and post power will be compared for beta band.
Time Frame
5-12 weeks
Title
Change from baseline on EEG power in theta band.
Description
EEG data will be analyzed for changes in power in theta band. Pre and post power will be compared for theta band.
Time Frame
5-12 weeks
Title
Change from baseline on EEG power in delta bands.
Description
EEG data will be analyzed for changes in power in delta bands. Pre and post power will be compared for delta band.
Time Frame
5-12 weeks
Title
Change from baseline on Disability Assessment
Description
Using the Pediatric evaluation of disability inventory with scores ranging from 0-100 with higher scored indicating greater functionality.
Time Frame
5-12 weeks
Title
Change from baseline on fMRI measures of connectivity
Description
fMRI data will be probed for change from baseline on measures of connectivity.
Time Frame
5-12 weeks
Title
Change from baseline on fMRI regional activation patterns.
Description
fMRI data will be probed for change from baseline on measures of regional activation.
Time Frame
5-12 weeks
Title
Change from baseline on Motor Assessment
Description
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.
Time Frame
5-12 weeks
Title
Change from baseline on goal specific assessment
Description
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.
Time Frame
5-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie C DeLuca, PhD
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fralin Biomedical Research Institute at Virginia Tech
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29258560
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.
Results Reference
background
PubMed Identifier
32042435
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.
Results Reference
background
PubMed Identifier
30782701
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.
Results Reference
background

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

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