Informations générales (source: ClinicalTrials.gov)
Pilot Study Investigating the Effects of Cathodal Transcranial Direct Current Stimulation (tDCS) on Executive Functions of Patients With Autism Without Mental Retardation. TRANSFEX Study (TRANSFEX)
Interventional
N/A
Centre Hospitalier du Rouvray (Voir sur ClinicalTrials)
décembre 2016
août 2017
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier du Rouvray - 76300 - Sotteville-lès-Rouen - France | Maud ROTHARMEL, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
- 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).
- 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.