NCT03235596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

June 1, 2017

Enrollment Period

8 months

First QC Date

June 21, 2017

Last Update Submit

July 31, 2017

Conditions

Autism Spectrum Disorder

Keywords

executive functionstDCS

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale

    30 days

  • Behavioral dysexecutive functions

    30 days

  • Trail Making Test A and B

    30 days

  • Stroop Test

    30 days

  • Verbal Fluency Test

    30 days

Study Arms (1)

treated arm

EXPERIMENTAL

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

Interventions

tDCSDEVICE

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

treated arm

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;
  • Subjects who are deprived of their liberty by decision of a judicial or administrative authority.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier du Rouvray

Sotteville-lès-Rouen, 76300, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Central Study Contacts

Maud ROTHARMEL, MD

CONTACT

maud.rotharmel@ch-lerouvray.fr

Martine REYMOND

CONTACT

martine.reymond@ch-lerouvray.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: It's an interventional, prospective and monocentric pilot study.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2017

First Posted

August 1, 2017

Study Start

December 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)