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

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
tDCS
Sponsored by
Centre Hospitalier du Rouvray
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring executive functions, tDCS

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier du RouvrayRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treated arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
Stroop Test
Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
Verbal Fluency Test
Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).

Full Information

First Posted
June 21, 2017
Last Updated
July 31, 2017
Sponsor
Centre Hospitalier du Rouvray
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1. Study Identification

Unique Protocol Identification Number
NCT03235596
Brief Title
Effects of Cathodal tDCS on Executive Functions in Autism
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier du Rouvray

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
executive functions, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
It's an interventional, prospective and monocentric pilot study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treated arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes
Primary Outcome Measure Information:
Title
Cognitive dysexecutive functions
Description
Score changes in Wisconsin Card Sorting test between assessment at day 1(inclusion) and assessment at day 30 (end of the study).
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Description
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).
Time Frame
30 days
Title
Behavioral dysexecutive functions
Description
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).
Time Frame
30 days
Title
Trail Making Test A and B
Description
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).
Time Frame
30 days
Title
Stroop Test
Description
Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
Time Frame
30 days
Title
Verbal Fluency Test
Description
Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maud ROTHARMEL, MD
Email
maud.rotharmel@ch-lerouvray.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Martine REYMOND
Email
martine.reymond@ch-lerouvray.fr
Facility Information:
Facility Name
Centre Hospitalier du Rouvray
City
Sotteville-lès-Rouen
ZIP/Postal Code
76300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maud ROTHARMEL, MD
Email
maud.rotharmel@ch-lerouvray.fr
First Name & Middle Initial & Last Name & Degree
Martine Reymond
Email
martine.reymond@ch-lerouvray.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Cathodal tDCS on Executive Functions in Autism

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