MicrocephalyNCT04816175
Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
A study testing Acquire Therapy in people with Microcephaly and Hyperkinesis With Developmental Delay, run by Virginia Polytechnic Institute and State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Microcephaly, Hyperkinesis With Developmental Delay, Global Developmental Delay
- What is being tested?
- Acquire Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 11 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.
Who cannot join
- Medical Instability
- Under 6 months of age over 15 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Fralin Biomedical Research Institute at Virginia Tech
Roanoke, Virginia, 24016
About this study
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.
Read the 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.
- Being tested
- Acquire Therapy
- Keywords
- Global Developmental Delay, Hyperkinesis, Microcephaly, Neurorehabilitation, Intensive Interventions
- Medical subject headings
- Microcephaly, Learning Disabilities, Hyperkinesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquire TherapyBehavioural
This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acquire Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-12 weeks
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5-12 weeks
Change from baseline on fMRI measures of connectivity
fMRI data will be probed for change from baseline on measures of connectivity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start30 Apr 2019
- Primary completion30 Dec 2021
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MicrocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As an early phase study, all enrolled children will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Cerebral Palsy and Developmental Medicine
- Responsible party
- Principal investigator, Stephanie DeLuca, Virginia Polytechnic Institute and State University
- Investigators
- Stephanie C DeLuca, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04816175
- Sponsor's protocol ID
- IRB #18-490
- Status last verified
- Oct 2022
- First submitted
- 22 Jan 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29258560Mann 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.
PubMed 32042435Ramey 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.
PubMed 30782701
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Therapy for Children With Microcephaly, Hyperkinetic Movements, or Global Developmental Delay
- ClinicalTrials.gov ID
- NCT04816175
- Acronym / sponsor ID
- IRB #18-490
- Keywords
- Global Developmental Delay, Hyperkinesis, Microcephaly, Neurorehabilitation, Intensive Interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- American Academy of Cerebral Palsy and Developmental Medicine
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As an early phase study, all enrolled children will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Treatment Intervention | Experimental | Behavioral: Acquire TherapyAll children will receive 3-5 weeks of intensive neuromotor Acquire therapy, an operant conditioning, play based therapy that maximizes therapeutic movements, attention, and engagement. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Diagnosis of Global Developmental Delay with Microcephaly or hyperkinetic movements.
Key exclusion criteria (2 listed)
- Medical Instability
- Under 6 months of age over 15 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acquire TherapyThis intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function | Behavioural | Treatment Intervention |
Primary outcome
Change from baseline on Motor Function Assessment
Time frame: 5-12 weeks
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.
13 secondary outcomes
Change from baseline on measure of EEG coherence in alpha band
Time frame: 5-12 weeks
Change from baseline on measure of EEG coherence in theta band.
Time frame: 5-12 weeks
Change from baseline on measure of EEG coherence in beta band.
Time frame: 5-12 weeks
Change from baseline on measure of EEG coherence in delta band.
Time frame: 5-12 weeks
Change from baseline on EEG power in alpha band.
Time frame: 5-12 weeks
Change from baseline on EEG power in beta band.
Time frame: 5-12 weeks
Change from baseline on EEG power in theta band.
Time frame: 5-12 weeks
Change from baseline on EEG power in delta bands.
Time frame: 5-12 weeks
Change from baseline on Disability Assessment
Time frame: 5-12 weeks
Change from baseline on fMRI measures of connectivity
Time frame: 5-12 weeks
Change from baseline on fMRI regional activation patterns.
Time frame: 5-12 weeks
Change from baseline on Motor Assessment
Time frame: 5-12 weeks
Change from baseline on goal specific assessment
Time frame: 5-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 29258560DeLuca 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.
- Background: PubMed 32042435Mann 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.
- Background: PubMed 30782701Ramey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie C DeLuca, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acquire Therapy in people with Microcephaly and Hyperkinesis With Developmental Delay, run by Virginia Polytechnic Institute and State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on Motor Function Assessment (time frame: 5-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04816175, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022; AzTrials last refreshed its copy on 1 Nov 2026.