Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders

Phase 1

• Conditions: Visual Perceptual Weakness; Social Behavior; EEG With Periodic Abnormalities; Fluency Disorder; Attention
• Interventions: Drug: Risperidone; Device: tDCS or Transcranial Direct Current Stimulation

• Registration Number: NCT06368726
• Lead Sponsor: Spanish Foundation for Neurometrics Development

Brief Summary

Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS

Detailed Description

tDCS will be applied to 90 children diagnosed with ASD with Mu activity in one of their two temporal lobes and to another 90 children tDCS will not be applied but rather conventional treatments such as the Denver method, etc., in addition to collecting their electroencephalograms in eyes open condition, evoked potentials will be performed. with Mismatch Nega...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-05-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age between 7 and 15 years old
• Diagnosis: PDD, ASD or PANDAS
• Have genetic alterations with geneticist reports like: mutation, random mating between organisms, random fertilization or crossing over (or recombination) between chromatids of homologous chromosomes during meiosis.
• Natural birth without caesarean or complications
• Normal Pregnancy

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Exclusion Criteria

• Head Trauma
• Brain Injuries like meningitis or encephalitis, including SaRS, Herpes or MERS infections
• Epilepsy
• Rare Diseases with Auto-Immune Disease
• Rare diseases with Endocrinology problems
• Fever or Biochemical problems in the First Blood Test (First Visit)
• Vaccines Reactions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional ASD approach	Risperidone	The childs receive their tradicional interventions, Risperidone according to child's weight, diet, educational or speech therapies, pictographs.
This group of childs will receive tDCS sessions	tDCS or Transcranial Direct Current Stimulation	This children receive 100 sessions during 12 monts in 4 groups of 25 sessions 2 per week of 30 minutes with a separation between them of at least 72 hours

Primary Outcome Measures

Name	Time	Method
FFT	12 months	Change in Voltage for every frequency band
ERP MMN changes	12 months	Changes in P300 wave amplitude
Power Density Spectrum Changes or PSD	12 Months	Amplitude of the PSD
ERP MMN Changes	12 Monts	Changes in P300 wave latency

Secondary Outcome Measures

Name	Time	Method
Social Skills	12 months	We used SSRS Scale Total Teacher Scale
Visual Contact	12 months	P200 wave amplitude in occipital lobe
Attention	12 months	Using ATTC scale average Scale
Language	12 months	GhostBusters Res Spoken Language and Listening Average Score from 40 Cards

Trial Locations

Locations (1)

New Remedies; 🇬🇧 Liverpool, Merseyside, United Kingdom