Effects of Cathodal tDCS on Executive Functions in Autism

Autism Spectrum Disorder Clinical Trial

— TRANSFEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03235596
• Other study ID #: 2016-A00805-46
• Status: Recruiting
• Phase: N/A
• First received: June 21, 2017
• Last updated: July 31, 2017
• Start date: December 2016
• Est. completion date: August 2017

Study information

• Verified date: June 2017
• Source: Centre Hospitalier du Rouvray
• Contact: Maud ROTHARMEL, MD
• Email: maud.rotharmel[@]ch-lerouvray.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Device:
• tDCS
cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes

Locations

Country	Name	City	State
France	Centre Hospitalier du Rouvray	Sotteville-lès-Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier du Rouvray

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive dysexecutive functions	Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).	30 days
Secondary	Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale	Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale between assessment at day 1 (inclusion), assessment at day 20 and assessment day 30 (end of the study).	30 days
Secondary	Behavioral dysexecutive functions	Score changes in the behavioral dysexecutive syndrome battery (Inventaire du Syndrome Dysexécutif Comportemental, ISDC) and the restricted and repetitive behaviors rating scale (Echelle d'évaluation des Comportements Répétitifs et Restreints, EC2R) between assessment at day 1 (inclusion) and assessment at day 30 (end of the study) (interview of the person accompanying).	30 days
Secondary	Trail Making Test A and B	Score changes in the Trail Making test A and B between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).	30 days
Secondary	Stroop Test	Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).	30 days
Secondary	Verbal Fluency Test	Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).	30 days