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Clinical Study on Multimodal MRI Features in Children with Neurological Injury

Clinical Study on Multimodal MRI Features in Children with Neurological Injury

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125461
Enrollment
Unknown
Registered
2026-05-27
Start date
2026-05-30
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Global developmental delay,Intellectual disability,Cerebral palsy,Disorders of consciousness

Interventions

Case group: Patients with global developmental delay, intellectual disability, cerebral palsy, and disorders of consciousness.:Noneeutic intervention)
Control group: Age- and sex-matched healthy developing children:None

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Case Group: 1. Clinically diagnosed with one of the following conditions: a. Global Developmental Delay (GDD) meeting the DSM-5 diagnostic criteria; b. Intellectual Disability (ID) with an Intelligence Quotient (IQ) = 8 years with adequate cognitive function), written assent must also be obtained. Control Group: 1. Age- and sex-matched to the case group (+/- 1 year). 2. No personal or family history of neurological disorders. 3. Normal developmental milestones (for children) or normal cognitive function (for adolescents). 4. No contraindications to MRI examination. 5. Voluntary participation with signed informed consent (for children, signed by the parent or legally authorized guardian).

Exclusion criteria

Exclusion criteria: 1. Contraindications to MRI examination, including: a. Implanted cardiac pacemaker, cochlear implant, or intracranial metallic implant (titanium alloy excluded, provided magnetic compatibility is confirmed); b. Claustrophobia precluding cooperation; c. Severe scoliosis or other postural limitations preventing supine positioning. 2. Comorbid neurological conditions requiring prioritized intervention (e.g., structural brain malformation, active epilepsy requiring immediate treatment). 3. Severe cardiopulmonary insufficiency precluding supine positioning. 4. History of neurosurgery within the past 3 months that may affect brain structure or function. 5. Inability to complete the scan without sedation indication or with sedation contraindication.

Design outcomes

Primary

MeasureTime frame
Total brain volume;Default mode network (DMN) functional connectivity strength;Fractional anisotropy (FA);N-acetylaspartate/Creatine (NAA/Cr) ratio;

Secondary

MeasureTime frame
Pearson correlation coefficient (r) between multimodal MRI parameters and clinical scale scores (Gesell DQ, GMFM, CRS-R);Classification accuracy, sensitivity, and specificity (case vs. control) derived from multimodal MRI-based machine learning model;

Countries

China

Contacts

Public ContactDengna Zhu

The Third Affiliated Hospital of Zhengzhou University

zhudengna@126.com+86 138 3814 1626

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026