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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-07-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation.

Study Groups

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Traditional ASD approach

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

Group Type ACTIVE_COMPARATOR

Risperidone

Intervention Type DRUG

Risperidone Risperidone according to child's weighs

This group of childs will receive tDCS sessions

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

Group Type EXPERIMENTAL

tDCS or Transcranial Direct Current Stimulation

Intervention Type DEVICE

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

Interventions

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tDCS or Transcranial Direct Current Stimulation

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

Intervention Type DEVICE

Risperidone

Risperidone Risperidone according to child's weighs

Intervention Type DRUG

Other Intervention Names

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tES Transcranial Electrical Stimulation Diet, educational or speech therapies, pictographs

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No