Indications, Safety & Cautions
The mobile EEG-device (Orbit) together with the app, is used for home-based neurofeedback training.
The home-based neurofeedback training is aiming to alleviate and/or treat symptoms of ASD and ADHD in children ages 6-18 years. The training app is designed to be used for 10-30 hours (cumulative) over multiple weeks.
The patient has to have a diagnosis from a licensed professional, with one of the following disorders targeted for intended use.
According to ICD-11:
- 6A02.0 Autism spectrum disorder without disorder of intellectual development and with mild or no impairment of functional language
- 6A02.1 Autism spectrum disorder with disorder of intellectual development and with mild or no impairment of functional language
- 6A02.2 Autism spectrum disorder without disorder of intellectual development and with impaired functional language
- 6A02.3 Autism spectrum disorder with disorder of intellectual development and with impaired functional language
- 6A02.Y Other specified autism spectrum disorder
- 6A02.Z Autism spectrum disorder, unspecified
- 6A05.0 Attention deficit hyperactivity disorder, predominantly inattentive presentation
- 6A05.1 Attention deficit hyperactivity disorder, predominantly hyperactive-impulsive presentation
- 6A05.2 Attention deficit hyperactivity disorder, combined presentation
- 6A05.Y Attention deficit hyperactivity disorder, other specified presentation
- 6A05.Z Attention deficit hyperactivity disorder, presentation unspecified
According to ICD-10:
- F84.0 Autistic disorder
- F84.1 Atypical autism
- F84.5 Asperger’s syndrome
- F90.0 Attention-deficit hyperactivity disorder, predominantly inattentive type
- F90.1 Attention-deficit hyperactivity disorder, predominantly hyperactive type
- F90.2 Attention-deficit hyperactivity disorder, combined type
- F90.8 Attention-deficit hyperactivity disorder, other type
- F90.9 Attention-deficit hyperactivity disorder, unspecified type
Epilepsy is a contraindication of the ASD training. Patients with an epilepsy diagnosis are not allowed to enroll in the Brainhero ASD therapy. The reason for this is that extensive trainings similar to a segment of the Brainhero’s ASD training (down-training) were associated with an increase in epileptiform activity in adult patients with intractable epilepsy. To make Brainhero as safe as possible, the total duration of the down-training segment of the Brainhero therapy has been kept extremely short. The training is therefore far from the duration reported to produce side effects in adult epileptic patients.
Regardless of whether they are under any therapy or not, up to 30% of children with ASD will be diagnosed with epilepsy before becoming adults. (Besag, F. M. Epilepsy in patients with autism: links, risks and treatment challenges. Neuropsy-chiatr. Dis. Treat. 14, 1–10 (2017))
Epilepsy is more likely to be diagnosed in children with autism that also suffer from severe intellectual disability. As such, both epilepsy and severe intellectual disability are contraindications of the ASD training.
Before beginning this or any other form of therapy, please consult a physician or relevant medical professional. The patient has to have a diagnosis from a licensed professional, with one of the listed disorders. We recommend that the patient stays in contact with a pediatrician, neurologist or certified neurofeedback practitioner while training with Brainhero.
List of Contraindications:
- According to ICD-11:
- 6A02.5 Autism spectrum disorder with disorder of intellectual development and with absence of functional language
- 6A00.2 Disorder of intellectual development, severe
- 6A00.3 Disorder of intellectual development, profound
- 6A00.Z Disorders of intellectual development, unspecified
- 8A60 Epilepsy due to structural or metabolic conditions or diseases
- 8A61 Genetic or presumed genetic syndromes primarily expressed as epilepsy
- 8A62 Epileptic encephalopathies
- 8A66 Status epilepticus
- 8A67 Acute repetitive seizures
- 8A6Y Other specified epilepsy or seizures
- 8A6Z Epilepsy or seizures, unspecified
According to ICD-10:
- F72. Severe intellectual disabilities
- F73. Profound intellectual disabilities
- F78. Other intellectual disabilities
- F79. Unspecified intellectual disabilities
- G40. Epilepsy and recurrent seizures
- presence of brain tumours
- presence of any implantable medical devices or prosthesis. This includes pacemakers, intracranial electrodes, implanted defibrillators, implantable neurostimulators, deep brain stimulators, or any other prosthesis
- cranial pathologies (e.g. holes, plaques) or prosthesis. This includes cochlear implants.
- Not suitable for children under the age of 6.
- Do not use the device on skin with lesions or broken skin.
- Use care and appropriate sanitation protocols if using the device on persons with communicable diseases including HIV.
Potential adverse effects:
Our EEG device combined with the Brainhero app allows children with Autism Spectrum Disorder (=ASD) and/or ADHD to train with neurofeedback. The training was reported to be safe in the intended patient category (children 6-18 years old) when applied for 10-30 hours over up to 6 months. The therapy with Brainhero is limited to 20h over the course of 6 months. No side effects were recorded in these conditions.
Similar trainings in adults have been associated with transitory side effects such as:
- mood swings
These effects occured in conjunction with longer training sessions and ceased after the training was paused.
If your child experiences serious medical incidents (such as seizures), contact a doctor immediately, stop the training and report to the Brainhero Care Team.
In addition, the incident will be reported to the responsible public health authority. Any possible connection with the training will be investigated. Our highest priority is to maintain and continuously improve the high standard of safety for our patients.
Before starting the therapy it is essential to read the manual carefully and always use the device in compliance with the specifications of the manual.
Do not let your child use the device unattended.
Failure to comply with the minimum and maximum frequency of trainings indicated by the therapy plan might negatively impact effectiveness and safety. Training more than advised by the the Brainhero Care Team can only be recommended based on the patient’s quantitative EEG and is strictly prohibited if this measurement is not available.
For medical questions, please contact your child’s healthcare provider. If you are experiencing a medical emergency, please dial 112. Brainhero’s products are not intended to be used as a stand-alone therapeutic and are no substitution for your child’s medication.
For questions regarding the therapy with Brainhero, contact our Brainhero Care Team by calling +43 (0) 1 997 42 94 or writing a mail to email@example.com