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Clinical study on transcranial alternating current stimulation in the treatment of global developmental delay

Clinical study on transcranial alternating current stimulation in the treatment of global developmental delay

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098348
Enrollment
Unknown
Registered
2025-03-06
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-03-10

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 (true stimulation group):On the basis of conventional rehabilitation treatment, the experimental group of children will receive transcranial alternating current stimulation treatmen
Control group (sham stimulation group):Children in the control group will receive regular rehabilitation training and be given pseudo-stimulation therapy with the same frequency and duration, with the

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 5 Years

Inclusion criteria

Inclusion criteria: (1) Age: 24 months ~60 months; (2) Meet the diagnostic criteria for global developmental delay in the DSM-5; (3) GESELL Development Scale assessment: two or more ability areas below 75 points, which must include adaptive performance district; (4) Parents or guardians agree to participate in the study, complete the pre-treatment examination, and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with limb movement disorders such as cerebral palsy and spinal cord injury; (2) Patients with severe hearing or visual impairment or other diseases affecting assessment; (3) Patients with epilepsy or other serious neurological diseases; (4) There is a clear cause of developmental delay, such as encephalitis after birth, brain trauma, cerebral hemorrhage, etc., or a clear diagnosis of heredity patients with metabolic diseases and neurodegenerative diseases; (5) Have a pacemaker or other electronic implant; (6) There are metal implants or intracranial metal fragments; (7) Recently received other brain stimulation treatment; (8) Allergic or contraindicated to electrical stimulation therapy.

Design outcomes

Primary

MeasureTime frame
Gesell Developmental Schedules;

Secondary

MeasureTime frame
Functional Near-Infrared Spectroscopy;Electroencephalogram;Normal Development of Social Skills from Infame to Junior High School Children(S-M) score;Child Behavior Checklist (CBCL);Clinical global Impression Improvement Scale (CGI-I);Parent observation scale;

Countries

China

Contacts

Public ContactZhu Dengna

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: Feb 4, 2026