N/A
N=225
Fronto-temporal tDCS Mproves Fluency & Empathy in ASD Kids
Autism · ASD
Bottom Line
View on ClinicalTrials.gov: NCT02004236 ↗Enrolled (actual)
225
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Verbal Fluency — 9.3; 10.5; 9.9; 8.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tRNS Fronto-temporal cortex (Device); tRNS over fusiform temporal cortex (Device); tRNS with sham (Device)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Spanish Foundation for Neurometrics Development
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Verbal Fluency |
9.3; 10.5; 9.9; 8.3; 10.4; 10 | — |
| PRIMARY Sociability |
30.6; 32.1; 31.8; 19.4; 20.2; 30.1 | — |
| SECONDARY Ratio Theta/Beta Before tDCS |
25; 30; 26 | — |
| SECONDARY Theta Amplitude in T5 Before tDCS |
3.2; 2.7; 3.5 | — |
| SECONDARY Ratio Theta/Beta After tDCS |
12; 14; 25 | — |
| SECONDARY Theta Amplitude in T5 After tDCS |
2.2; 1.5; 3.3 | — |
| SECONDARY Reaction Time in ECPT Before tDCS |
756; 698; 722 | — |
| SECONDARY Omission Errors Before tDCS |
85; 91; 88 | — |
| SECONDARY Commission Errors Before tDCS |
6; 8; 19 | — |
| SECONDARY P3b Wave Amplitude Before tDCS |
0.5; 0.7; 0.3 | — |
| SECONDARY Reaction Time After tDCS |
690; 556; 714 | — |
| SECONDARY Omissions Errors After tDCS |
68; 57; 20 | — |
| SECONDARY Commission Errors After tDCS |
6; 8; 19 | — |
| SECONDARY P3b Wave Amplitude After tDCS |
2.1; 1.8; 0.4 | — |
Summary
Interventional, prospective, randomized, double-blind, placebo-controlled and parallel assignment study, in which patients with Autism Spectrum Disorder (ASD) are two types of intervention by transcranial random noise stimulation (tRNS), to improve verbal fluency and empathy.
Eligibility Criteria
Inclusion Criteria
- Patients between 5 and 12 years.
- Meet DSM-IV criteria for autism spectrum disorder.
- Patients who have been diagnosed at least 2 years before inclusion in the study.
Exclusion Criteria
- Acute visual or hearing loss.
- Traumatic brain injury.
- Other neurological disorders: migraine, epilepsy, tuberous sclerosis ...
- Trauma at birth.
- Mental retardation.
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT02004236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.