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OpenTrials
Enrolling by Invitation

NCT Number: NCT06368726

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

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

Enrolling by Invitation

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Key information

Age range

6 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bigdata4brain LLC

Albuquerque, New Mexico, 87113, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS or Transcranial Direct Current Stimulation

Device

We use weak currents applied over the child's scalp over 30 minutes twice a week during 100 days

Other names: tES Transcranial Electrical Stimulation

Risperidone

Drug

Risperidone Risperidone according to child's weighs

Other names: Diet, educational or speech therapies, pictographs

Primary outcomes

  1. FFT

    Time frame: 12 months

    Change in Voltage for every frequency band

  2. Power Density Spectrum Changes or PSD

    Time frame: 12 Months

    Amplitude of the PSD

  3. ERP MMN changes

    Time frame: 12 months

    Changes in P300 wave amplitude

  4. ERP MMN Changes

    Time frame: 12 Monts

    Changes in P300 wave latency

Secondary outcomes

  1. Attention

    Time frame: 12 months

    Using ATTC scale average Scale

  2. Social Skills

    Time frame: 12 months

    We used SSRS Scale Total Teacher Scale

  3. Language

    Time frame: 12 months

    GhostBusters Res Spoken Language and Listening Average Score from 40 Cards

  4. Visual Contact

    Time frame: 12 months

    P200 wave amplitude in occipital lobe

Sponsors and collaborators

Lead sponsor

Spanish Foundation for Neurometrics Development

Other

Registry information

Official study title

Results of the Application of 80 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

Acronym: tDCS&ASD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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