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A multicenter study for the injection of rat nerve growth factor in the treatment of temporary mental retardation in children

A multicenter study for the injection of rat nerve growth factor in the treatment of temporary mental retardation in children

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032283
Enrollment
Unknown
Registered
2020-04-25
Start date
2020-05-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Temporary mental development disorder in children

Interventions

Experimental group:Routine rehabilitation treatment + Injection of rat nerve growth factor
Control group:Routine rehabilitation treatment

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 12 months to 36 months; 2. Cerebral palsy was clinically diagnosed; 3. Clinical classification is spastic diplegia; 4. Gross motor function grading system (GMFCS) grade I ~ III; 5. Willing to comply with the test plan, the guardian of the subject voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Other types of cerebral palsy and other types of spastic cerebral palsy; 2. Those with severe visual or auditory impairment who cannot cooperate with the evaluator or Gesell scale adaptive behavior DQ < 40; 3, known to have other motor development behind/disorder, unexplained movements, language or cognitive function back/degradation phenomenon, autism spectrum disorders, skeletal muscle diseases, spinal cord disease, peripheral nerve disease, chromosome disease, genetic metabolic disease, endocrine disease, autoimmune disease and other serious systemic diseases, blood system diseases, infectious disease; 4. The liver and kidney functions were 2 times beyond the normal range, or were not 2 times beyond the normal range, but the abnormality was judged by the researchers to have clinical significance; 5. Electroencephalogram indicates epileptic discharge or epilepsy; 6. Allergic to rat nerve growth factor; 7. Oral, intramuscular, intrathecal injection of a drug to reduce muscle tone, or surgical treatment, 180 days prior to the start of the study, to the study period or to the follow-up period; 8. Those who have received the same mNGF, other neuroprotective drugs, traditional Chinese medicine preparations (oral or topical) or health food (such as DHA) that has a clear effect on promoting neurodevelopment and have not stopped taking drugs/drugs for more than 14 days; 9. Have participated in clinical trials of other new drugs within the last 90 days; 10. In the opinion of the researcher, other students should not participate in this study.

Design outcomes

Primary

MeasureTime frame
Gesell developmental diagnostic scale;Infant - junior high school students social life ability scale;Head MRI;

Countries

China

Contacts

Public ContactWu De

The First Affiliated Hospital of Anhui Medical University

845177603@qq.com+86 13966730422

Outcome results

None listed

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