Clinical trial NCT03235596: Effects of Cathodal tDCS on Executive Functions in Autism
Official title: Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: executive functions
tDCS
Lead sponsor: Centre Hospitalier du Rouvray
Sponsor class: OTHER_GOV
First posted: 2017-08-01
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It's an interventional, prospective and monocentric pilot study.
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* With ICD-10 criteria for autism without mental retardation or Asperger syndrome;
* Patient with adaptive capacity and autonomy complaints.
* Patients with stable treatments for at least 4 weeks prior and during all the study;
* Patient with no history of tDCS;
* Patients affiliated to a social security system;
* Patients who give their informed written consents;
* For women of childbearing age: effective contraception; required (estrogen and progestogen or intra-uterine device or tubal ligation) for at least 1 month before starting treatment (a negative pregnancy test has been obtained).

Exclusion Criteria:

* Skin disease, dementia, history of epileptic seizures, brain tumor or metallic implants/implanted electrical devices.
* Patients who followed à cognitive remediation program during the last 6 months;
* Subjects currently treated with magnetic or electrical stimulation techniques (e.g.: transcutaneous or root stimulation).
* Women of childbearing age with no adequate contraception, pregnant or lactating women;
* Patients participating or having participated in an interventional clinical trial within 30 days prior to the inclusion visit;
* Subjects who are deprived of their liberty by decision of a judicial or administrative authority.

Primary outcomes:
measure: Cognitive dysexecutive functions
timeFrame: 30 days
Secondary outcomes:
measure: Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale
timeFrame: 30 days
measure: Behavioral dysexecutive functions
timeFrame: 30 days
measure: Trail Making Test A and B
timeFrame: 30 days
measure: Stroop Test
timeFrame: 30 days
measure: Verbal Fluency Test
timeFrame: 30 days
Other outcomes:
Locations:
city: Sotteville-lès-Rouen
country: France
facility: Centre Hospitalier du Rouvray
Study officials:
References: