NCT03235596

Effects of Cathodal tDCS on Executive Functions in Autism

Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Centre Hospitalier du Rouvray · Other Government
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

It's an interventional, prospective and monocentric pilot study concerning adult patients with autism without mental retardation. The primary outcome is to assess the effects of cathodal transcranial direct current stimulation (tDCS) on the left dorsolateral prefrontal cortex (DLPFC) on the executive functions of patients with autism without mental retardation or with Asperger syndrome. The secondary outcomes are to evaluate the safety of this treatment and to evaluate its impact on impaired social communication and on restricted or repetitive behaviors.

Detailed description

The patients concerned by the study are aged 20 to 50 years old. They meet ICD-10 criteria for autism without mental retardation or Asperger syndrome and they have adaptive capacity and autonomy complaints. They stable treatments for at least 4 weeks prior and during all the study and no history of tDCS. Women of childbearing age with no adequate contraception, pregnant or lactating women are excluded. This is an interventional, prospective and monocentric pilot study. The patient is informed about the clinical study during the psychiatric consultation. The patient is provided with a cooling-off period of several days. During the inclusion visit, the executive functions of the patient are assessed (WSCT, Stroop, TMT A and B and verbal fluency test). If 2 pathological tests are found among all measured scores: administration of ISDC and EC2R (interview of the person accompanying) and planning of the first tDCS session 15 days later. If no pathological test is found : study exit. The treatment consists in 10 sessions of cathodal tDCS applied over the left dorsolateral prefrontal cortex (DLPFC) at 2mA. Each session lasts 15 minutes. They are 2 sessions per day. Ten days after the end of tDCS treatment, patients are assessed for executive functions and behavioral dysexecutive functions (EC2R and ISCD).

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	tDCS	cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-08-01
• Last updated: 2017-08-01

Locations

1 site across 1 country: France