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

NCT06368726 | Enrolling By Invitation Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: SFND04042024
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• FFT

  Change in Voltage for every frequency band

  12 months

• Power Density Spectrum Changes or PSD

  Amplitude of the PSD

  12 Months

• ERP MMN changes

  Changes in P300 wave amplitude

  12 months

• ERP MMN Changes

  Changes in P300 wave latency

  12 Monts

Secondary Outcomes (4)

• Attention

  12 months

• Social Skills

  12 months

• Language

  12 months

• Visual Contact

  12 months

Study Arms (2)

Traditional ASD approach

ACTIVE COMPARATOR

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

Drug: Risperidone

This group of childs will receive tDCS sessions

EXPERIMENTAL

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

Device: tDCS or Transcranial Direct Current Stimulation

Interventions

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

Also known as: tES Transcranial Electrical Stimulation

This group of childs will receive tDCS sessions

Risperidone DRUG

Risperidone Risperidone according to child's weighs

Also known as: Diet, educational or speech therapies, pictographs

Traditional ASD approach

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Citlalli Mellado Balanzar: lead

Study Sites (1)

Bigdata4brain LLC

Albuquerque, New Mexico, 87113, United States

Location

Related Publications (8)

• Moliadze V, Lyzhko E, Schmanke T, Andreas S, Freitag CM, Siniatchkin M. 1 mA cathodal tDCS shows excitatory effects in children and adolescents: Insights from TMS evoked N100 potential. Brain Res Bull. 2018 Jun;140:43-51. doi: 10.1016/j.brainresbull.2018.03.018. Epub 2018 Apr 3.

  PMID: 29625151 RESULT

• Moliadze V, Schmanke T, Andreas S, Lyzhko E, Freitag CM, Siniatchkin M. Stimulation intensities of transcranial direct current stimulation have to be adjusted in children and adolescents. Clin Neurophysiol. 2015 Jul;126(7):1392-9. doi: 10.1016/j.clinph.2014.10.142. Epub 2014 Oct 28.

  PMID: 25468234 RESULT

• Palm U, Segmiller FM, Epple AN, Freisleder FJ, Koutsouleris N, Schulte-Korne G, Padberg F. Transcranial direct current stimulation in children and adolescents: a comprehensive review. J Neural Transm (Vienna). 2016 Oct;123(10):1219-34. doi: 10.1007/s00702-016-1572-z. Epub 2016 May 12.

  PMID: 27173384 RESULT

• Buchanan DM, Amare S, Gaumond G, D'Angiulli A, Robaey P. Safety and Tolerability of tDCS across Different Ages, Sexes, Diagnoses, and Amperages: A Randomized Double-Blind Controlled Study. J Clin Med. 2023 Jun 28;12(13):4346. doi: 10.3390/jcm12134346.

  PMID: 37445385 RESULT

• Antal A, Luber B, Brem AK, Bikson M, Brunoni AR, Cohen Kadosh R, Dubljevic V, Fecteau S, Ferreri F, Floel A, Hallett M, Hamilton RH, Herrmann CS, Lavidor M, Loo C, Lustenberger C, Machado S, Miniussi C, Moliadze V, Nitsche MA, Rossi S, Rossini PM, Santarnecchi E, Seeck M, Thut G, Turi Z, Ugawa Y, Venkatasubramanian G, Wenderoth N, Wexler A, Ziemann U, Paulus W. Non-invasive brain stimulation and neuroenhancement. Clin Neurophysiol Pract. 2022 May 25;7:146-165. doi: 10.1016/j.cnp.2022.05.002. eCollection 2022.

  PMID: 35734582 RESULT

• Luckhardt C, Schutz M, Muhlherr A, Mossinger H, Boxhoorn S, Dempfle A, Salvador R, Ruffini G, Pereira HC, Castelo-Branco M, Latinus M, Bonnet-Brilhault F, Siemann J, Siniatchkin M, Ecker C, Freitag CM. Phase-IIa randomized, double-blind, sham-controlled, parallel group trial on anodal transcranial direct current stimulation (tDCS) over the left and right tempo-parietal junction in autism spectrum disorder-StimAT: study protocol for a clinical trial. Trials. 2021 Apr 6;22(1):248. doi: 10.1186/s13063-021-05172-1.

  PMID: 33823927 RESULT

• Rothenberger A, Heinrich H. Electrophysiology Echoes Brain Dynamics in Children and Adolescents With Tourette Syndrome-A Developmental Perspective. Front Neurol. 2021 Feb 15;12:587097. doi: 10.3389/fneur.2021.587097. eCollection 2021.

  PMID: 33658971 RESULT

• Buchanan DM, Bogdanowicz T, Khanna N, Lockman-Dufour G, Robaey P, D'Angiulli A. Systematic Review on the Safety and Tolerability of Transcranial Direct Current Stimulation in Children and Adolescents. Brain Sci. 2021 Feb 10;11(2):212. doi: 10.3390/brainsci11020212.

  PMID: 33578648 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Social Behavior

Interventions

Transcranial Direct Current Stimulation; Risperidone; Diet; Speech Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Neuropsychologist

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

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 16, 2024
• Study Start: April 1, 2024
• Primary Completion: December 12, 2025
• Study Completion (Estimated): June 2, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)