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RecruitingPHASE2INTERVENTIONAL

Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)

This study is investigating a new way to help children and young people with autism spectrum disorder (ASD) aged 9 to 18 years. It's looking at a gentle type of brain stimulation called transcranial direct current stimulation (tDCS), which can be used at home. This treatment is non-invasive, meaning it doesn't involve surgery, and is thought to be safe and well-tolerated. The aim is to see if tDCS can improve social communication – how young people interact and express themselves – and also help them with 'self-regulation', which is about managing their emotions and behaviours. Participants will use either the real tDCS device or a dummy (sham) version for three weeks, and researchers will compare the results.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
Enrolment target
20
Start
20 Oct 2023
Estimated completion
30 Sep 2025

What is this study about?

This study is about exploring a gentle brain stimulation method called transcranial direct current stimulation, or tDCS, for young people with autism spectrum disorder (ASD). ASD can sometimes make it harder for children and teenagers to communicate with others and manage their feelings and reactions. This study hopes to find out if tDCS, which can be used comfortably at home, could be a helpful tool.

tDCS involves placing small pads on the head that deliver a very mild electrical current. This current is non-invasive, meaning it doesn't go deep into the brain or involve surgery. Previous research suggests tDCS might be safe and could help improve social communication skills and how young people with ASD regulate their emotions and behaviours. This particular study is an early stage (Phase 2) trial, which means it builds on earlier findings but is still gathering more information.

The main goal is to see if regular use of tDCS at home over three weeks can make a difference. Researchers will look at how it affects brain activity and whether there are noticeable improvements in social communication and emotional control. This information will be crucial for planning larger studies in the future, helping us understand if this treatment could eventually become a widely available option.

Key takeaways

  • This study explores a gentle brain stimulation (tDCS) for young people with autism.
  • It aims to improve social communication and how they manage their feelings and behaviours.
  • Participants aged 9-18 will use a device at home for three weeks.
  • Half will receive actual stimulation, and half a dummy device.
  • The study is an early phase and will help plan future research.

Who may be eligible?

This study is looking for young people with a diagnosis of autism spectrum disorder (ASD) who are between 9 and 18 years old. They should be facing difficulties with social communication, for example, talking to others or understanding social cues, or with managing their own feelings and behaviours.

To take part, children must be able to comfortably use the tDCS device. It's important that they don't have certain medical conditions or implants. For example, if a child has ever had seizures, or if there's a family history of seizures, they wouldn't be able to join. Also, if they have any metal implants in their body or other brain conditions like epilepsy or a history of stroke, they wouldn't be suitable for this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Is your child 9 to 18 years old?
  2. Does your child have a diagnosis of autism spectrum disorder (ASD)?
  3. Does your child struggle with social communication or managing their feelings/behaviours?
  4. Has your child ever had seizures, or is there a family history of seizures?
  5. Does your child have any metal implants in their body?
  6. Does your child have any other serious neurological conditions (like epilepsy or stroke)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your child will be randomly chosen to receive either the real tDCS device or a 'sham' (dummy) device. The sham device looks and feels like the real one but doesn't deliver the actual stimulation. This helps researchers compare the effects accurately. Both devices will be used at home for three weeks.

During the study, there will be some checks and assessments to see how your child is doing. These will involve looking at their social communication and how they manage their feelings and behaviours. The researchers will also look at how the tDCS might be affecting brain activity. The total duration of active participation primarily involves using the device for three weeks, with assessments before, during, and after this period.

Potential risks and benefits

Taking part in this study could potentially offer some benefits to your child, such as improvements in social communication skills and better management of their feelings and behaviours. However, as this is a research study, there's no guarantee that your child will experience these benefits, especially if they are in the sham group. Potential risks associated with tDCS are generally mild, such as temporary skin irritation under the pads or a slight tingling sensation, though these are usually well-tolerated. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (1)

  • Holland Bloorview Kids Rehabilitation Hosptail
    Verified postcode
    Toronto, Canada· Recruiting

Common questions

What is tDCS?

tDCS (transcranial direct current stimulation) is a gentle way to stimulate the brain using a very mild electrical current, applied through pads on the scalp.

Is tDCS safe?

It's considered safe for most people and has been used in many studies. Any side effects are usually mild and temporary, like a slight tingle.

Will my child know if they are getting the real or dummy treatment?

No, neither you nor your child will know. This helps make sure the results are fair and accurate, as expectations can sometimes influence outcomes.

What does 'self-regulation' mean?

Self-regulation refers to a child's ability to manage their own emotions, thoughts, and behaviours in different situations.

What happens after the three weeks of treatment?

After three weeks, researchers will continue to assess your child to see if there are any lasting changes and to gather important information for future studies.

How to find out more

Deryk Beal, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Home-based Transcranial Direct Current Stimulation (tDCS) to…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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