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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Social Behavior; Attention; EEG With Periodic Abnormalities; Visual Perceptual Weakness; Fluency Disorder
• Intervention / Treatment: Drug: Risperidone; Device: tDCS or Transcranial Direct Current Stimulation

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L1 0AH
      • New Remedies Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traditional ASD approach; The childs receive their tradicional interventions, Risperidone according to child's weight, diet, educational or speech therapies, pictographs.	Drug: Risperidone; Risperidone Risperidone according to child's weighs; Other Names: Diet, educational or speech therapies, pictographs
Experimental: 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	Device: 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; Other Names: tES Transcranial Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spanish Foundation for Neurometrics Development
• Collaborators: Fundacion para la Salud Materno Infantil
• Investigators: Study Director: Fernando Vargas Torcal, PhD, Fundacion Salud Infantil

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: SFND04042024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes