Autism Spectrum DisorderTRANSFEXNCT03235596
Effects of Cathodal tDCS on Executive Functions in Autism
A study testing tDCS in people with Autism Spectrum Disorder, run by Centre Hospitalier du Rouvray at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Maud ROTHARMEL, MD contact
Martine REYMOND contact
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier du Rouvray
Sotteville-lès-Rouen, 76300
Maud ROTHARMEL, MD, maud.rotharmel@ch-lerouvray.fr
Martine Reymond, martine.reymond@ch-lerouvray.fr
About this study
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
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.
Read the 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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- tDCS
- Keywords
- executive functions, tDCS
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Secondary outcomes (5)
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).
Measured: 30 days
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).
Measured: 30 days
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).
Measured: 30 days
Stroop Test
Score changes in the Stroop between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
Measured: 30 days
Verbal Fluency Test
Score changes in Verbal Fluency Test between assessment at day 1 (inclusion) and assessment at day 30 (end of the study).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- It's an interventional, prospective and monocentric pilot study.
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Rouvray
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235596
- Sponsor's protocol ID
- 2016-A00805-46
- Acronym
- TRANSFEX
- Status last verified
- Jun 2017
- First submitted
- 21 Jun 2017
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03235596
- Acronym / sponsor ID
- TRANSFEX / 2016-A00805-46
- Conditions
- Autism Spectrum Disorder
- Keywords
- executive functions, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Hospitalier du RouvrayOther government
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 1 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- It's an interventional, prospective and monocentric pilot study.
| Arm | Type | Receives |
|---|---|---|
| treated arm | Experimental | Device: tDCSPatients 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCScathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes | Device | treated arm |
Primary outcome
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).
5 secondary outcomes
Score changes in the tDCS adapted version of the Udvalg pour Kliniske Undersøgelser (UKU) Side Effect Rating Scale
Time frame: 30 days
Behavioral dysexecutive functions
Time frame: 30 days
Trail Making Test A and B
Time frame: 30 days
Stroop Test
Time frame: 30 days
Verbal Fluency Test
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maud ROTHARMEL, MD contact
Martine REYMOND contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Autism Spectrum Disorder, run by Centre Hospitalier du Rouvray at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maud ROTHARMEL, MD (maud.rotharmel@ch-lerouvray.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive dysexecutive functions (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.