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Effects of Cathodal tDCS on Executive Functions in Autism (TRANSFEX)

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ClinicalTrials.gov Identifier: NCT03235596
Recruitment Status : Recruiting
First Posted : August 1, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier du Rouvray

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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: tDCS Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Intervention Model Description: It's an interventional, prospective and monocentric pilot study.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017


Arm Intervention/treatment
Experimental: treated arm
Patients received cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2 mA during 15 minutes. They have 10 sessions in 5 consecutive days, 2 sessions per day.
Device: tDCS
cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes




Primary Outcome Measures :
  1. Cognitive dysexecutive functions [ Time Frame: 30 days ]
    Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).


Secondary Outcome Measures :
  1. Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale [ Time Frame: 30 days ]
    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).

  2. Behavioral dysexecutive functions [ Time Frame: 30 days ]
    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).

  3. Trail Making Test A and B [ Time Frame: 30 days ]
    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).

  4. Stroop Test [ Time Frame: 30 days ]
    Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).

  5. Verbal Fluency Test [ Time Frame: 30 days ]
    Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235596


Contacts
Contact: Maud ROTHARMEL, MD maud.rotharmel@ch-lerouvray.fr
Contact: Martine REYMOND martine.reymond@ch-lerouvray.fr

Locations
France
Centre Hospitalier du Rouvray Recruiting
Sotteville-lès-Rouen, France, 76300
Contact: Maud ROTHARMEL, MD       maud.rotharmel@ch-lerouvray.fr   
Contact: Martine Reymond       martine.reymond@ch-lerouvray.fr   
Sponsors and Collaborators
Centre Hospitalier du Rouvray

Responsible Party: Centre Hospitalier du Rouvray
ClinicalTrials.gov Identifier: NCT03235596     History of Changes
Other Study ID Numbers: 2016-A00805-46
First Posted: August 1, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier du Rouvray:
executive functions
tDCS

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders