AttentionPhase 1/2tDCS&ASDNCT06368726
Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders
A Phase 1/2 study testing tDCS or Transcranial Direct Current Stimulation and Risperidone in people with Attention and Visual Perceptual Weakness, run by Spanish Foundation for Neurometrics Development at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention, Visual Perceptual Weakness, Social Behavior
- What is being tested?
- tDCS or Transcranial Direct Current Stimulation and Risperidone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 2 Sep 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Attention, Visual Perceptual Weakness, Social Behavior, Fluency Disorder, EEG With Periodic Abnormalities
- Being tested
- tDCS or Transcranial Direct Current Stimulation, Risperidone, Sham tDCS
- Medical subject headings
- Social Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS or Transcranial Direct Current StimulationDevice
Also called tES Transcranial Electrical Stimulation
We use weak currents applied over the child's scalp over 30 minutes twice a week during 100 days
RisperidoneDrug
Also called Diet, educational or speech therapies, pictographs
Risperidone Risperidone according to child's weighs
Sham tDCSOther
Participants will receive sham transcranial direct current stimulation (tDCS). The device and electrode placement will be identical to the active stimulation groups, but the electrical current will be turned off after a brief initial ramp-up period to mimic the physical sensation of active tDCS without delivering therapeutic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Traditional ASD approach | Active comparator | The childs receive their tradicional interventions, Risperidone according to child's weight, diet, educational or speech therapies, pictographs. Receives: 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 Receives: Device: tDCS or Transcranial Direct Current Stimulation |
| Sham tDCS | Sham comparator | Participants will receive sham transcranial direct current stimulation (tDCS). The device and electrode placement will be identical to the active stimulation groups, but the electrical current will be turned off after a brief initial ramp-up period to mimic the physical sensation of active tDCS without delivering therapeutic stimulation. Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFT
Change in Voltage for every frequency band
Measured: 12 months
Power Density Spectrum Changes or PSD
Amplitude of the PSD
Measured: 12 Months
ERP MMN changes
Changes in P300 wave amplitude
Measured: 12 months
ERP MMN Changes
Changes in P300 wave latency
Measured: 12 Monts
Secondary outcomes (4)
Attention
Using ATTC scale average Scale
Measured: 12 months
Social Skills
We used SSRS Scale Total Teacher Scale
Measured: 12 months
Language
GhostBusters Res Spoken Language and Listening Average Score from 40 Cards
Measured: 12 months
Visual Contact
P200 wave amplitude in occipital lobe
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start1 Apr 2024
- Primary completion12 Aug 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AttentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Foundation for Neurometrics Development
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368726
- Sponsor's protocol ID
- SFND04042024
- Acronym
- tDCS&ASD
- Status last verified
- Sep 2026
- First submitted
- 5 Apr 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 29625151Moliadze 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.
PubMed 25468234Palm 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.
PubMed 27173384Buchanan 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.
PubMed 37445385Antal 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.
PubMed 35734582Luckhardt 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.
PubMed 33823927Rothenberger 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.
PubMed 33658971Buchanan 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.
PubMed 33578648