Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05444816 |
| Other study ID # |
MyMind_CIP_001 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 14, 2021 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Brainhero GmbH |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study investigates the feasibility and the effects of training at home with personalised
neurofeedback in children with an autism spectrum diagnosis and comorbidities. The
personalisation relies on quantitative electroencephalography recordings performed in a
clinic, which are also used to evaluate the efficiency of the home-based training, along with
standardized questionnaires. The active phase is expected to last roughly 6 months, during
which children are expected to complete multiple hours of training and complete an interim
evaluation. Whether the training's effects are long lasting is evaluated in a follow-up
phase, 3 months after the active phase.
Description:
Autism spectrum disorders (ASD) affect one in 59 children in the developed world and are
characterised by significant impairments in social abilities and repetitive/restrictive
behaviours. ASD are heterogeneous in nature and manifestations, and usually come in
conjunction with other neurodevelopmental disorders, of which attention deficit hyperactivity
disorder (ADHD), epilepsy and intellectual disability (low Intelligence Quotient; IQ) are the
most common. Interventions to alleviate ASD are in many instances hard to quantify in terms
of effectiveness, leading to an inability of caregivers and practitioners to assign patients
to an appropriate treatment approach.
Accumulating evidence highlights the utility of electroencephalography and its mathematical
analysis, quantitative electroencephalography (qEEG), in discriminating between ASD and
typically developing children in early infancy and throughout development. Additionally,
previous studies show that EEG-based neurofeedback can be used to correct brain activity
abnormalities. This approach builds on models of brain plasticity and uses operant
conditioning of the patient's electroencephalogram (EEG) to induce brain adaptation and
self-regulation, which further tunes cognition, emotions and behaviour. Prior scientific
evidence suggests impaired mirror neuron activity in ASD, which connects to mu-rhythm
abnormalities, as recorded on an EEG. Neurofeedback-mediated training of mu-rhythm power at
C4, a EEG electrode position, in children with ASD resulted in improved social behaviour in
previously published research. A similar approach using the company's Brain Hero®
neurofeedback game in ASD children with or without ADHD and/or epilepsy and irrespective of
IQ, which participated as beta testers in a previous usability study, resulted in improved
concentration and relaxation abilities, and improved mu-rhythm at C4.
The objective of this feasibility study is therefore to track the efficiency of home-based
personalised Brain Hero® neurofeedback in children with ASD and comorbidities. To identify
whether the brain activity at other electrode positions and frequencies has been influenced
by this neurofeedback approach and to track overall normalization of qEEG parameters in
comparison with typically developing children, the investigators propose to engage the
patients in a longitudinal clinical study evaluating changes in whole brain activity. To this
end, they will employ a commercially available qEEG device to record whole scalp EEGs from
Brain Hero® users, once before beginning neurofeedback and then again once every month over
the course of neurofeedback. These EEGs will be analyzed using Neuroguide® (Applied
Neurosciences) and power and coherence compared with their database of typically developing
individuals. The points and frequencies of the neurofeedback training will be individually
adjusted to specifically correct the EEG abnormalities detected in the patient. In comparison
with the current C4 alpha-mu training and C4 alpha-, beta- and theta-tracking using spectral
power measurements (available now for all Brain Hero® beta users), this approach has the
advantage that it enables treatment personalization (e.g. training other electrode points and
power frequencies in addition to C4 alpha-mu, as well as coherence training) and a more
thorough tracking of treatment efficiency (by evaluating changes in spectral power and
coherences over the entire scalp). In addition, the investigators will track changes in
behavior using the Social Responsiveness Scale (SRS) 2 and the Behaviour Rating Inventory of
Executive Function (BRIEF), as well as with personalized interviews, which will be completed
by primary caregivers every three months.
Children or adolescents, male or female, aged 6-18 years, with an ASD diagnosis according to
the DSM-5 or ICD-10, irrespective of IQ, with or without ADHD or epilepsy will be included in
the study. Children with a diagnosis of schizophrenia, severe generalised anxiety disorder,
major depression, or other neurological disorders, or with a medical disorder requiring
systemic chronic medication with confounding psychoactive effects, as well as children with
muscle spasms affecting the facial muscles and interfering with electrode measurements will
be excluded from the study. Because of the high heterogeneity of ASD and its extremely
frequent association with other neurodevelopmental disorders (ADHD, epilepsy, low IQ), the
investigators expect that data from a minimum of 30 patients will be necessary. This is also
the sample size recommended for the case in which the differences in pre- and post- values
are not normally distributed. Because the aim of the study is beyond statistical significance
towards biological relevance, the investigators are aiming for an average effect size similar
to the ones reported in previous studies. Considering that this is a longitudinal study and a
significant number of patients might drop out (dropout rate estimated at 70% in studies
employing two groups and involving office/clinic visits for qEEGs), the investigators aim at
recruiting a total of 100 patients.
The study will be conducted over 9 months, of which 6 months are active training and 3 months
are follow-up phase, since the long-term effects of the neurofeedback training are also of
interest. A patient undergoing all training sessions and evaluations is considered to have
successfully completed the study.
The study will have reached its endpoint once complete data (all four time points, all qEEGs
and all questionnaires) will be gathered from 30 patients diagnosed with an ASD, whether or
not associated with comorbidities.
