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

Spanish Foundation for Neurometrics Development

Status and phase: Invitation-only; Phase 1

Conditions: EEG With Periodic Abnormalities; Fluency Disorder; Social Behavior; Attention; Visual Perceptual Weakness

Treatments: Drug: Risperidone; Device: tDCS or Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06368726

SFND04042024

Details and patient eligibility

About

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

Full 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 Negativity paradigm to calculate the P300 wave every 25 sessions with a rest of 5-6 weeks between every 25 sessions and the changes in voltage and frequency of the EEG will be analysed using FFT & PSD, as well as the latencies and amplitudes of its P300 wave.

Enrollment: 180 estimated patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Traditional ASD approach

Active Comparator group

Description:

The childs receive their tradicional interventions, Risperidone according to child's weight, diet, educational or speech therapies, pictographs.

Treatment:

Drug: Risperidone

This group of childs will receive tDCS sessions

Experimental group

Description:

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

Treatment:

Device: tDCS or Transcranial Direct Current Stimulation