Movement Disorders in ChildrenVPeMDNCT07695610
Pediatric Movement Disorders of Unknown Etiology in Vietnam (VPeMD)
An observational study of Movement Disorders in Children and Neuro Developmental Delay, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
Trial summary
This observational patient registry aims to describe the clinical phenotypes and genetic findings of Vietnamese children with movement disorders of unknown etiology. Eligible participants are children with clinically confirmed movement disorders after evaluation by pediatric neurology specialists and after exclusion… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Movement Disorders in Children, Neuro Developmental Delay, Neurogenetic Disorders
- What is being tested?
- Whole-Exome Sequencing
- How many people
- 50 participants
- Where
- 2 sitesVietnam
- Study dates
- 17 Apr 2026to 31 Jan 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Vietnamese children with clinically confirmed movement disorders of unknown etiology who are evaluated or treated at University Medical Center Ho Chi Minh City or Children's Hospital 1. Participants will be enrolled after clinical assessment by pediatric neurology specialists and after informed consent is obtained from legal guardians and/or participants when appropriate.
Who may be able to join
- Children younger than 18 years old.
- Patients with clinically confirmed movement disorders based on direct examination and/or video review by at least two pediatric neurology specialists.
- Patients with movement disorders of unknown etiology after appropriate neurological evaluation and exclusion of clear acquired causes.
- Patients evaluated or treated at University Medical Center Ho Chi Minh City or Children's Hospital 1 during the study period.
- Patients and/or legal guardians who provide written informed consent for study participation and genetic testing.
Who cannot join
- Patients with isolated or transient primary tic disorders.
- Patients with a confirmed acquired cause of movement disorder.
- Patients or legal guardians who decline participation or withdraw from the study.
- Patients with insufficient clinical information or unavailable biological samples for genetic analysis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
Children's Hospital 1, Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 700000
Linh B.Y Nguyen, MSc, MD, PPHD Candidate, +84 939077089, nbylinh.ncs25@ump.edu.vn
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, Ho Chi Minh City, 700000
Hieu L.T. Nguyen, AProf, MD, PhD, +84 908393616, ngletrunghieu@ump.edu.vn
About this study
Official title: Phenotypic and Genotypic Characterization of Pediatric Movement Disorders of Unknown Etiology in Vietnam
This observational patient registry aims to describe the clinical phenotypes and genetic findings of Vietnamese children with movement disorders of unknown etiology. Eligible participants are children with clinically confirmed movement disorders after evaluation by pediatric neurology specialists and after exclusion of clear acquired causes.
The study will collect clinical data, neurological examination findings, available laboratory and imaging results, and video recordings of abnormal movements when consent is provided. Blood samples will be collected for whole-exome sequencing and related genetic analysis. Genetic variants will be classified according to accepted clinical genetics standards and compared with the patients' clinical phenotypes.
The study is expected to improve understanding of the phenotypic and genotypic spectrum of pediatric movement disorders in Vietnam, support genetic counseling, and evaluate how genetic results may influence diagnosis, follow-up, prognosis, and treatment planning.
Read the detailed description
Movement disorders in children represent a heterogeneous group of neurological conditions that include dystonia, chorea, ataxia, myoclonus, tremor, tics, parkinsonism, and mixed movement disorders. The underlying causes are highly diverse and include genetic, metabolic, neurodegenerative, structural, immune-mediated, and acquired disorders. However, a substantial proportion of pediatric patients remain without a definitive diagnosis after standard clinical evaluation and routine investigations.
Recent advances in next-generation sequencing technologies, particularly whole-exome sequencing, have significantly improved the diagnostic yield in pediatric movement disorders and have contributed to the identification of novel disease-causing genes and genotype-phenotype correlations. Nevertheless, data regarding the clinical and genetic spectrum of pediatric movement disorders in Vietnam remain limited.
The VPeMD registry is a prospective observational patient registry designed to collect standardized clinical and genetic data from Vietnamese children with movement disorders of unknown etiology. Participants will undergo detailed clinical evaluation by pediatric neurology specialists, including assessment of movement phenomenology, neurological findings, developmental history, family history, neuroimaging findings, laboratory investigations, and treatment history.
Biological samples will be collected for genetic analysis, including whole-exome sequencing and additional molecular investigations when appropriate. Genetic variants will be interpreted according to internationally accepted standards and correlated with clinical manifestations.
The study aims to characterize the phenotypic and genotypic spectrum of pediatric movement disorders in Vietnam, evaluate diagnostic yield of genetic testing, identify genotype-phenotype correlations, and assess the potential impact of genetic diagnosis on patient management, prognosis, genetic counseling, and future therapeutic strategies.
- Being tested
- Whole-Exome Sequencing
- Keywords
- VPeMD, Vietnam, Whole Exome Sequencing, Pediatric movement disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-Exome SequencingDiagnostic test
Also called WES, Next-generation sequencing
Whole-exome sequencing will be performed on DNA extracted from peripheral blood samples to identify genetic variants associated with pediatric movement disorders. The test is used for genetic analysis and genotype-phenotype correlation in this observational registry and is not assigned as a treatment intervention.
| Study group | Role | What they receive |
|---|---|---|
| Vietnamese Pediatric Movement Disorder Cohort | Vietnamese children with clinically confirmed movement disorders of unknown etiology who meet the study eligibility criteria and are enrolled in the VPeMD registry. Participants will undergo standardized clinical data collection and genetic testing using whole-exome sequencing. Receives: Diagnostic Test: Whole-Exome Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Phenotypes of Pediatric Movement Disorders
Distribution of clinical movement disorder phenotypes among enrolled participants, including dystonia, chorea, ataxia, myoclonus, tremor, parkinsonism, stereotypies, and mixed movement disorders, based on pediatric neurology assessment and clinical records.
Measured: At enrollment
Secondary outcomes (3)
Diagnostic Yield of Whole-Exome Sequencing
Proportion of enrolled participants with pathogenic or likely pathogenic genetic variants identified by whole-exome sequencing and related genetic analysis.
Measured: From enrollment to return of genetic results, up to 12 months
Genotype-Phenotype Correlation
Correlation between identified genetic variants and clinical phenotypes of pediatric movement disorders will be assessed.
Genetic findings will be obtained from WES. Clinical phenotypes will be characterized using standardized neurological assessments, including movement disorder classification, age at onset, symptom distribution, disease progression, neurological comorbidities, developmental status, and neuroimaging findings when available.
The correlation between genotype and phenotype will be evaluated by comparing identified genetic variants with clinical characteristics of enrolled participants.
Measured: From enrollment to completion of clinical and genetic data analysis, up to 24 months
Impact of Genetic Diagnosis on Clinical Management
Proportion of participants whose diagnosis, prognosis, follow-up plan, genetic counseling, or treatment strategy is changed after genetic testing results become available.
Measured: From return of genetic results to follow-up assessment, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start17 Apr 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Bich Y Linh, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Linh B. Y Nguyen, MD, MSc, PHD Candidate, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695610
- Sponsor's protocol ID
- UMP-VPeMD-26298
- Acronym
- VPeMD
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves pediatric participants and sensitive genetic data. Data sharing is restricted by the approved ethics protocol, informed consent, and privacy considerations related to clinical and genomic information.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Genotypic Characterization of Pediatric Movement Disorders of Unknown Etiology in Vietnam
- ClinicalTrials.gov ID
- NCT07695610
- Acronym / sponsor ID
- VPeMD / UMP-VPeMD-26298
- Keywords
- VPeMD, Vietnam, Whole Exome Sequencing, Pediatric movement disorders
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 10 Jul 2026 (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 observational patient registry aims to describe the clinical phenotypes and genetic findings of Vietnamese children with movement disorders of unknown etiology. Eligible participants are children with clinically confirmed movement disorders after evaluation by pediatric neurology specialists and after exclusion of clear acquired causes.
The study will collect clinical data, neurological examination findings, available laboratory and imaging results, and video recordings of abnormal movements when consent is provided. Blood samples will be collected for whole-exome sequencing and related genetic analysis. Genetic variants will be classified according to accepted clinical genetics standards and compared with the patients' clinical phenotypes.
The study is expected to improve understanding of the phenotypic and genotypic spectrum of pediatric movement disorders in Vietnam, support genetic counseling, and evaluate how genetic results may influence diagnosis, follow-up, prognosis, and treatment planning.
Detailed description
Movement disorders in children represent a heterogeneous group of neurological conditions that include dystonia, chorea, ataxia, myoclonus, tremor, tics, parkinsonism, and mixed movement disorders. The underlying causes are highly diverse and include genetic, metabolic, neurodegenerative, structural, immune-mediated, and acquired disorders. However, a substantial proportion of pediatric patients remain without a definitive diagnosis after standard clinical evaluation and routine investigations.
Recent advances in next-generation sequencing technologies, particularly whole-exome sequencing, have significantly improved the diagnostic yield in pediatric movement disorders and have contributed to the identification of novel disease-causing genes and genotype-phenotype correlations. Nevertheless, data regarding the clinical and genetic spectrum of pediatric movement disorders in Vietnam remain limited.
The VPeMD registry is a prospective observational patient registry designed to collect standardized clinical and genetic data from Vietnamese children with movement disorders of unknown etiology. Participants will undergo detailed clinical evaluation by pediatric neurology specialists, including assessment of movement phenomenology, neurological findings, developmental history, family history, neuroimaging findings, laboratory investigations, and treatment history.
Biological samples will be collected for genetic analysis, including whole-exome sequencing and additional molecular investigations when appropriate. Genetic variants will be interpreted according to internationally accepted standards and correlated with clinical manifestations.
The study aims to characterize the phenotypic and genotypic spectrum of pediatric movement disorders in Vietnam, evaluate diagnostic yield of genetic testing, identify genotype-phenotype correlations, and assess the potential impact of genetic diagnosis on patient management, prognosis, genetic counseling, and future therapeutic strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vietnamese Pediatric Movement Disorder Cohort | – | Diagnostic Test: Whole-Exome SequencingVietnamese children with clinically confirmed movement disorders of unknown etiology who meet the study eligibility criteria and are enrolled in the VPeMD registry. Participants will undergo standardized clinical data collection and genetic testing using whole-exome sequencing. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Vietnamese children with clinically confirmed movement disorders of unknown etiology who are evaluated or treated at University Medical Center Ho Chi Minh City or Children's Hospital 1. Participants will be enrolled after clinical assessment by pediatric neurology specialists and after informed consent is obtained from legal guardians and/or participants when appropriate.
Key inclusion criteria (5 listed)
- Children younger than 18 years old.
- Patients with clinically confirmed movement disorders based on direct examination and/or video review by at least two pediatric neurology specialists.
- Patients with movement disorders of unknown etiology after appropriate neurological evaluation and exclusion of clear acquired causes.
- Patients evaluated or treated at University Medical Center Ho Chi Minh City or Children's Hospital 1 during the study period.
- Patients and/or legal guardians who provide written informed consent for study participation and genetic testing.
Key exclusion criteria (4 listed)
- Patients with isolated or transient primary tic disorders.
- Patients with a confirmed acquired cause of movement disorder.
- Patients or legal guardians who decline participation or withdraw from the study.
- Patients with insufficient clinical information or unavailable biological samples for genetic analysis.
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 |
|---|---|---|
| Whole-Exome SequencingAlso: WES, Next-generation sequencingWhole-exome sequencing will be performed on DNA extracted from peripheral blood samples to identify genetic variants associated with pediatric movement disorders. The test is used for genetic analysis and genotype-phenotype correlation in this observational registry and is not assigned as a treatment intervention. | Diagnostic test | Vietnamese Pediatric Movement Disorder Cohort |
Primary outcome
Clinical Phenotypes of Pediatric Movement Disorders
Time frame: At enrollment
Distribution of clinical movement disorder phenotypes among enrolled participants, including dystonia, chorea, ataxia, myoclonus, tremor, parkinsonism, stereotypies, and mixed movement disorders, based on pediatric neurology assessment and clinical records.
3 secondary outcomes
Diagnostic Yield of Whole-Exome Sequencing
Time frame: From enrollment to return of genetic results, up to 12 months
Genotype-Phenotype Correlation
Time frame: From enrollment to completion of clinical and genetic data analysis, up to 24 months
Impact of Genetic Diagnosis on Clinical Management
Time frame: From return of genetic results to follow-up assessment, up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves pediatric participants and sensitive genetic data. Data sharing is restricted by the approved ethics protocol, informed consent, and privacy considerations related to clinical and genomic information.
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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.
Linh B. Y Nguyen, MD, MSc, PHD Candidate principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders in Children and Neuro Developmental Delay, run by University of Medicine and Pharmacy at Ho Chi Minh City at 2 sites in Vietnam.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bich Y L Nguyen, MD, MSc, PhD Candidate (+84 939077089, nbylinh.ncs25@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Phenotypes of Pediatric Movement Disorders (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.