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
Children with all forms of epilepsy are excluded from the therapy based on preliminary data and screen time requirements.
Severe comorbid intellectual disabilities are excluded based on information with respect to verbal, nonverbal and performance IQ of the children with ASD that participated in the studies showing clinical efficacy of the neurofeedback protocol to be implemented by Orbit and the app. Particularly, nonverbal children with ASD and / or ADHD will be excluded based on lack of evidence that the training will be clinically efficient in this patient category.
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.
- Always document each training unit by placing one sticker in the appropriate location in the therapy plan. Do not continue to train with the EEG after completion of 257 training units as indicated in the therapy plan.
Potential adverse effects:
Our EEG device (Orbit) combined with the trainings app allows children with ASD and/or ADHD to train with two standard protocols, which were reported to be safe in the intended patient category (children 6-18 years old) when applied for 10-30 hours over up to 20 weeks. No side effects were recorded in either the ASD, ADHD or the typically developing population.
However, neurofeedback in general has been associated with transitory side effects such as:
seizures, in very rare cases.
Headaches can be a nocebo effect or the result of the procedure itself. For instance, frequent changes in the quality of the visual or the audio reward, watching a blurry screen, can cause headache independent of the neurofeedback training. However, neurofeedback training has been associated with headaches.
We ask kindly to document any occurrence of headaches in the therapy plan and contact the Brainhero Care Team if they suspect any association between the training and the adverse event. In this case, you will be asked to send pictures of the training plan. A decision with respect to continuation of training and contact of specialists will be made after a phone interview.
It is expected that any headaches that might occur in conjunction with the use of our product will reside once the use is interrupted.
Neurofeedback training has been associated with tiredness. The user is kindly asked to document any occurrence of sudden tiredness in the training plan and contact the Brainhero Care Team. Changes in the frequency and/or duration of training sessions, as well as temporary interruption of training might be recommended.
If you suspect these or any other side effects to be associated with the training with this device, please report them immediately to the Brainhero Care team.
In case of headaches or tiredness, you will be advised to temporarily discontinue training. In case of seizures, we will report the side effect to the Federal Office for Safety in Health Care (BASG, Federal Office for Safety in Health Care) and refer the patient for neurological investigations. Please be informed that 20-30% of the children with ASD will develop seizures before becoming adults (Besag, F. M. Epilepsy in patients with autism: links, risks and treatment challenges. Neuropsy-chiatr. Dis. Treat. 14, 1–10 (2017)). The trainings currently available with this device are not intended for patients with a seizure disorder. Please discontinue use if a seizure disorder is diagnosed.
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. MyMind’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