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Clinical study on transcranial direct current stimulation combined with cognitive training for executive function in children with global developmental delay

Exploring the Impact of Transcranial Direct Current Stimulation on Executive Function in Children with Global Developmental Delay

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107310
Enrollment
Unknown
Registered
2025-08-08
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Global Developmental Delay

Interventions

Experimental Group:transcranial Direct Current Stimulation (tDCS) with real stimulation + cognitive training
Control Group:transcranial Direct Current Stimulation (tDCS) with sham stimulation + cognitive training

Sponsors

Children's Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: 1.Aged 24–60 months; 2. Meeting the diagnostic criteria for Global Developmental Delay (GDD) specified in the *Diagnostic and Statistical Manual of Mental Disorders, 5th Edition* (DSM-?); 3. Right-handed; 4.Having mild to moderate GDD with an adaptive quotient > 40 as assessed by the Gesell Developmental Diagnostic Scale; 5.Able to complete executive function task assessments; 6.Possessing basic cognitive abilities and being able to follow single-step instructions; 7.Having guardians who voluntarily participate in the study and sign the informed consent form; 8.Having no prior experience of transcranial direct current stimulation (tDCS); 9.Having no recent receipt of neuromodulation.

Exclusion criteria

Exclusion criteria: 1. Children with GDD comorbid with other conditions such as epilepsy, autism spectrum disorder (ASD), and attention deficit hyperactivity disorder (ADHD); 2.Children with low compliance who are unable to complete intervention training; 3.Those with insufficiency of important organ functions including heart, kidney, and lung; 4.Those with complications such as traumatic brain injury or encephalitis; 5.Those with hearing or visual impairments; 6.Those with imaging findings indicating ineligibility for transcranial electrical stimulation; 7. Children who are unable to complete all assessment items.

Design outcomes

Secondary

MeasureTime frame
Gesell Developmental Diagnosis Scale;S-M Scale of Social - living Ability for Infants to Junior High School Students;—

Primary

MeasureTime frame
Inhibitory control: Cat-Dog Go/No-Go task;Cognitive flexibility: Dimensional Change Card Sort task;Working memory:Spin the Pots task;—

Countries

China

Contacts

Public ContactShao Jingjing

Children's Hospital of Nanjing Medical University

15951871013@163.com+86 159 5187 1013

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026