Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05635318 |
| Other study ID # |
QEEG-NF for ADHD |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2023 |
| Est. completion date |
January 1, 2024 |
Study information
| Verified date |
November 2022 |
| Source |
Assiut University |
| Contact |
El-Sayed Khalil Abdel-Karim, Professor |
| Phone |
01556588807 |
| Email |
Khalilsay53[@]aun.edu.eg |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Attention deficit/hyperactivity disorder (ADHD) is a common neurological disorder in
children, mainly manifesting as attention deficit, excessive hyperactivity, and impulsivity.
It is a chronic condition that affects millions of children and often continues into
adulthood.
The prevalence of ADHD in the worldwide is approximately 5%, predominantly occurring in boys,
and more than half of patients continue to experience symptoms into adulthood. Children with
ADHD have moral disorders and learning difficulties, and these factors will seriously affect
their academic achievements and familial and social relationships; thus, treatment is
necessary.
Currently, the treatment for ADHD is usually pharmacological intervention, such as
methylphenidate, Atomoxetine…. etc. However, research has suggested that pharmacological
intervention has side effects on nervous system development in children, and the long-term
efficacy is uncertain. In recent years, the efficacy of neurofeedback (NF) therapy, as a type
of biofeedback method, has been proven in many diseases, such as mild cognitive impairment,
epilepsy, and autism, depression, and anxiety.
NF converts signals such as EEG into visual or auditory information, and then subjects
selectively enhance or inhibit certain components through training. There are three common NF
protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow
cortical potentials (SCP) training. This study adopts the theta/beta NF protocol. As a
promising nonpharmacological alternative treatment for ADHD, the efficacy of NF has been
proven in many studies.
The use of quantitative EEG neurofeedback as an add-on therapy can be markedly beneficial to
shorten the period of pharmacological treatment and with minimal side effects.
Description:
Attention deficit/hyperactivity disorder (ADHD) is a common neurological disorder in
children, mainly manifesting as attention deficit, excessive hyperactivity, and impulsivity.
It is a chronic condition that affects millions of children and often continues into
adulthood. ADHD includes a combination of persistent problems, such as difficulty sustaining
attention, hyperactivity, and impulsive behavior. Based on the Diagnostic and Statistical
Manual of Mental Disorders, Fourth Edition (DSM-IV), the American Psychiatric Association has
divided ADHD into three subtypes: predominantly inattention (ADHD-I), predominantly
hyperactive-impulsive (ADHD-HI) and a combination of both (ADHD-C) (1) The prevalence rate of
ADHD in the worldwide is approximately 5%, predominantly occurring in boys, and more than
half of patients continue to experience symptoms into adulthood (2). Most children with ADHD
have moral disorders and learning difficulties, and these factors will seriously affect their
academic achievements and familial and social relationships; thus, prompt treatment is
necessary. (3) Historically, conventional EEG has added little to the understanding of
childhood psychiatric disorders, other than to rule out epilepsy or space occupying lesions.
However, the advent of computerized, quantitative methods, together with new neuroimaging
techniques as brain sources localization and the availability of normative databases both of
normal subjects and of subjects with definite pathologies has greatly enhanced the clinical
application in neurodevelopmental disorders. Furthermore, in these past years, it has become
more and more apparent that groups of patients with neuropsychiatric disorders, who meet
symptom based diagnostic criteria for specific disorders (Diagnostic and Statistical Manual
of Mental Disorders, Fourth Edition [DSM-IV] or International Classification of Diseases,
10th Revision [ICD-10]) have varied responses to treatment, despite their relatively
homogeneous clinical presentation. Using clinical diagnosis, the "treatment of choice" leads
to a positive response approximately 60% of the time. (4) This poor response rate suggests
heterogeneity within these relatively homogeneous clinical populations. In this direction,
the term personalized medicine is becoming more and more common, a medical procedure that
separates patients into different groups based on their electrophysiological profiles and
predicted response to the quantitative EEG. This has allowed the study of single subjects and
to customize health care, with decisions and treatments tailored to each individual patient,
as well as improvement of knowledge of the pathophysiological mechanisms of specific
diseases.
Currently, the treatment for ADHD is usually pharmacological intervention, such as
methylphenidate, Atomoxetine…. etc. However, research has suggested that pharmacological
intervention has side effects on nervous system development in children, and the long-term
efficacy is uncertain. In recent years, the efficacy of neurofeedback (NF) therapy, as a type
of biofeedback method, has been proven in many diseases, such as mild cognitive impairment,
epilepsy, and autism, depression and anxiety. Stemming from Skinner's operant conditioned
reflexes theory, NF is to enable individuals to actively control and adjust according to
their own EEG changes to achieve a certain criterion and finally achieve the purpose of
regulating brain function. (5) Neurofeedback (also called neurotherapy or
electroencephalogram [EEG] biofeedback) is a type of biofeedback that uses conditioning to
train people to improve regulation of their brain-wave patterns by providing them with
real-time video/audio information about their brain's electrical activity measured from scalp
electrodes. In effect, the conditioning is based on feedback given to the patient that is
contingent on the patient's EEG pattern.
First described qualitatively as "brain waves" on the EEG by Hans Berger in 1924, the
electrical activity of the brain was thought to reflect changes in the brain's functional
state while awake or asleep, or to denote brain diseases such as epilepsy. (6) EEG activity,
characterized in terms of rhythmic activity measured in hertz (Hz, the number of waves per
second), is divided into specifically named frequency bands, corresponding to functional
activity and arousal state: the delta band corresponds to slow-wave sleep state (up to 4 Hz),
Theta to a drowsy/inattentive state (4-8 Hz), alpha to a relaxed/wakeful/alert state (8-12
Hz), and beta to an active/attentive state (12-30 Hz).Most of the brain electrical activity
occurs in the 1- to 20-Hz range.
Within each band, there are recognizable functionally significant rhythms. For example, a
specific type of low beta activity (12-15 Hz) observed in the sensorimotor cortex is called
the sensorimotor rhythm. The amplitude of the sensorimotor rhythm is higher when the
sensory-motor areas are inactive (eg, during immobile states) and decreases when those areas
are activated (eg, during motor tasks). Therefore, the amplitude of the sensorimotor rhythm
is a measure of sensory-motor inhibition; that is, higher amplitude when the "brake is on"
and lower when the "brake is off." A mathematical approach to analyzing EEG data, called
quantitative electroencephalography (qEEG), can be used to develop a visual map of the type
and location of brain waves or rhythms. Other more specific wave patterns, such as
event-related potentials, can also be seen in the EEG. Event-related potentials are
electrical representations associated with sensory and cognitive processing occurring in
response to a stimulus or event. (7) Slow cortical potentials (SCPs) are one specific group
of event-related potentials. They are slow event-related direct-current shifts of the EEG
that correspond to the excitation threshold of large cortical cell assemblies. (8,9) Shifts
in the positive direction indicate an increase of the excitation threshold and a
corresponding inhibition of activation, whereas shifts in the negative direction, called the
contingent negative variation, reflect a reduction of the excitation threshold, and represent
cognitive preparation and increased cortical activation of a network. (8,10) The classical
conditioning of human EEG was first shown in the mid- 1930s, when researchers trained human
subjects to block a wave. (7,8) Operant conditioning, in which EEG-derived information is
used as instant feedback to the patient in realtime, was first used to alter the human EEG in
the 1960s (11,12,13) Since the 1960s, mainly using operant conditioning, there has been a
significant increase in the clinical application of NF to several neuropsychiatric
conditions, including ADHD, LD, developmental disabilities, cognitive/memory enhancement,
epilepsy, traumatic brain injury, stroke, alcoholism, substance abuse, antisocial
personality, autism, anxiety, depression, insomnia, and migraines.(14) There has also been a
significant increase, especially in the 21st century, in the number of published research and
dissertation studies TYPES OF NEUROFEEDBACK
There are 7 types of NF, Hammond (15) defines their use for various disorders:
1. The traditional and most frequently used is Frequency/Power NF, and it is the NF method
usually meant by the general term "neurofeedback." This technique typically entails the
use of 2 to 4 surface electrodes and is sometimes called "surface neurofeedback."
Developed in the 1960s to change the amplitude or speed of specific brain waves in
particular brain locations, it is used to treat ADHD, anxiety, insomnia, and LD.
2. Slow Cortical Potential Neurofeedback (SCP-NF) modifies the direction (positive or
negative) of slow cortical potentials and has been used to treat epilepsy, migraines,
and ADHD.
3. Low-Energy Neurofeedback System (LENS), developed in 1992, is a passive type of NF
involving delivery of a very weak electromagnetic signal to change a patient's brain
waves while the patient is motionless and has their eyes closed; it has been used to
treat traumatic brain injury, fibromyalgia, anger, restless legs syndrome, ADHD,
anxiety, depression, and insomnia.
4. Hemoencephalographic (HEG) Neurofeedback, developed in 1994, provides feedback about
cerebral blood flow to treat migraine.
5. Live Z-score Neurofeedback, developed in 1998, involves the continuous comparison of
multiple variables of brain electrical activity (eg, power, asymmetries, phase-lag,
coherence) to a normative database to give moment-to-moment feedback; it has been used
to treat insomnia.
6. Low-Resolution Electromagnetic Tomography (LORETA) was developed in 1994 to treat
depression, addictions, and obsessive-compulsive disorder. LORETA involves the use of 19
electrodes that are used to monitor phase, power, and coherence
7. The most recent type of NF, developed in 2003, is functional magnetic resonance imaging
(fMRI) NF, which allows patients to regulate their brain activity based on feedback of
activity from deep subcortical areas of the brain.
NF has been suggested for the treatment of ADHD because research indicates that many patients
with ADHD have more slow-wave (especially Theta, 3.5-8 Hz) power and less beta (12-20 Hz)
power, especially in the central and frontal regions, as well as reduced cortical negativity
(ie, a deviance in contingent negative variation) during cognitive preparation. These
brain-wave patterns probably reflect under arousal of the central nervous system associated
with the core ADHD symptoms of inattention, hyperactivity, and impulsivity. The goal of this
treatment is to reverse these functional characteristics of abnormal CNS physiology by
countering the physiological under arousal associated with ADHD.
NF converts signals such as EEG into visual or auditory information, and then subjects
selectively enhance or inhibit certain components through training. There are three common NF
protocols for ADHD: theta/beta training, sensorimotor rhythm (SMR) training, and slow
cortical potentials (SCP) training. (16) This study adopts the theta/beta NF protocol. As a
promising nonpharmacological alternative treatment for ADHD, the efficacy of NF has been
proven in many studies. Meisel et al. conducted a six-month follow-up trial that compared NF
and medication in children with ADHD and discovered significant academic performance
improvements in only the NF group (17). One study reported that NF can not only be used as a
therapy for many neuropsychiatric disorders but also improve the emotion and cognition of
healthy people (18) So the use of quantitative EEG neurofeedback as an add-on therapy can be
markedly beneficial to shorten the period of pharmacological treatment and with minimal side
effects.
