EEG Changes in Pediatrics With Language Dysfunction Evaluation of Sleep EEG Changes in Paediatric Patients With Language Dysfunction: A Follow up Study. EEG Changes in Pediatrics With Language Dysfunction

NCT05487521 | Completed Phase 3 FDA Drug

• 1 other identifier: M.D4312020
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

In general, the severity of the patients' language disorders fluctuated with the degree of EEG epileptiform activity . Since then, a spectrum of disorders, often referred to collectively as the epilepsy-aphasia spectrum, have been described that share features of sleep potentiated EEG abnormalities, cognitive problems, and rare or even absent clinical seizures . In our study , Investigators evaluated the sleep EEG changes in pediatrics with languague dysfunction then in patients with EEG changes , investigators gave treatment according to type of EEG changes and investigators did a follow up assessment of language , EEG changes and frequency of clinical seizures if present at first .

Conditions

Language Disorders in Children

Outcome Measures

Primary Outcomes (1)

• language age of the patient

  we follow up language age of the patient after treatment

  6 months

Study Arms (2)

Patients without EEG changes or clinical seizures

NO INTERVENTION

Patients with EEG changes or clinical seizures

EXPERIMENTAL

Drug: Methylprednisolone and or prednisolone

Interventions

Methylprednisolone and or prednisolone DRUG

we gave methylprednisolone and or prednisolone to patients with EEG activity and follow up the effect of the drug on language

Patients with EEG changes or clinical seizures

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• o Language delay (their language age is below their chronological age ),or Language regression (any convincing report of loss of previously acquired language skills, whether or not prior language development was reported as normal or delayed) (Meilleur et al., 2009)
• Age from 3 to 10 years old.

You may not qualify if:

• o Patients with hearing problems.
• Patients whose language delay can be explained by organic disease (e.g. post Hypoxic ischemic encephalopathy, known inborn error of metabolism - whether this language delay is isolated or occurring in the context of global developmental delay).
• Patients with mental delay.
• Patients with autism spectrum disorder ( according to DSM-5 standardized criteria, 2013)
• Enviromentally deprived patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Omnia Alaa Mahsoub

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Methylprednisolone; Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 4, 2022
• Study Start: February 20, 2020
• Primary Completion: November 10, 2021
• Study Completion: May 10, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

EG (1)