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

Attention Clinical Trial

— tDCS&ASD  

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06368726
• Other study ID #: SFND04042024
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: April 1, 2024
• Est. completion date: July 1, 2025

Study information

• Verified date: May 2024
• Source: Spanish Foundation for Neurometrics Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: July 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention
• Congenital Abnormalities
• EEG With Periodic Abnormalities
• Social Behavior

Intervention

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

Drug:
• Risperidone
Risperidone Risperidone according to child's weighs

Locations

Country	Name	City	State
United Kingdom	New Remedies	Liverpool	Merseyside

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Foundation for Neurometrics Development	Fundacion para la Salud Materno Infantil

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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, Santarn — View Citation

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. — View Citation

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/brainsc — View Citation

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, — View Citation

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. — View Citation

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.20 — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFT	Change in Voltage for every frequency band	12 months
Primary	Power Density Spectrum Changes or PSD	Amplitude of the PSD	12 Months
Primary	ERP MMN changes	Changes in P300 wave amplitude	12 months
Primary	ERP MMN Changes	Changes in P300 wave latency	12 Monts
Secondary	Attention	Using ATTC scale average Scale	12 months
Secondary	Social Skills	We used SSRS Scale Total Teacher Scale	12 months
Secondary	Language	GhostBusters Res Spoken Language and Listening Average Score from 40 Cards	12 months
Secondary	Visual Contact	P200 wave amplitude in occipital lobe	12 months

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