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

NCT04816175 | Completed

• 1 other identifier: IRB #18-490
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Microcephaly; Hyperkinesis With Developmental Delay; Global Developmental Delay

Keywords

Global Developmental Delay; Hyperkinesis; Microcephaly; Neurorehabilitation; Intensive Interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change from baseline on measure of EEG coherence in alpha band

  5-12 weeks

• Change from baseline on measure of EEG coherence in theta band.

  5-12 weeks

• Change from baseline on measure of EEG coherence in beta band.

  5-12 weeks

• Change from baseline on measure of EEG coherence in delta band.

  5-12 weeks

• Change from baseline on EEG power in alpha band.

  5-12 weeks

Study Arms (1)

Treatment Intervention

EXPERIMENTAL

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

Interventions

Acquire Therapy BEHAVIORAL

This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function

Treatment Intervention

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead
• American Academy of Cerebral Palsy and Developmental Medicine: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at Virginia Tech

Roanoke, Virginia, 24016, United States

Location

Related 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.

  PMID: 29258560 BACKGROUND

• 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.

  PMID: 32042435 BACKGROUND

• 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.

  PMID: 30782701 BACKGROUND

MeSH Terms

Conditions

Microcephaly; Learning Disabilities; Hyperkinesis

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias

Study Officials

• Stephanie C DeLuca, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Because all children will receive the intervention all parties involved will be aware that the participant has received the intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: As an early phase study, all enrolled children will receive the intervention.

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: March 25, 2021
• Study Start: April 30, 2019
• Primary Completion: December 30, 2021
• Study Completion: August 11, 2022
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)