The objective of the proposed research is to address the effectiveness of neurofeedback and exercise as non-pharmacological treatments for ADHD. The effects of neurofeedback and exercise will be assessed on three domains: behaviour, neurocognition,…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
ADHD symptoms
Secondary outcome
Neurocognition and Neurophysiology (QEEG and ERPs)
Background summary
ADHD is usually treated with methylphenidate, a widely established treatment.
Neurofeedback is becoming an increasingly popular non-pharmacological treatment
for ADHD but randomized controlled trials at the efficacy are lacking and the
origins of the observed improvements are poorly understood. Another
non-pharmacological intervention that has positive effects on neurocognition in
various populations is physical exercise. However, virtually nothing is known
about the effects of exercise in ADHD. Goal of the proposed research is to
examine the effects of neurofeedback and exercise on behaviour, neurocognition
and neurophysiology in children with ADHD and subsequently compare these
effects with each other and with methylphenidate.
Study objective
The objective of the proposed research is to address the effectiveness of
neurofeedback and exercise as non-pharmacological treatments for ADHD. The
effects of neurofeedback and exercise will be assessed on three domains:
behaviour, neurocognition, and neurophysiology.
Study design
This study is a pragmatic RCT with three treatment arms (MPH, neurofeedback and
exercise) and three outcome domains (behaviour, neurocognition and
neurophysiology).
Intervention
Neurofeedback
Children will be trained with the neurofeedback system Theraprax using
standardized protocols. The training will be presented like a computer game. At
the beginning of each session, baseline values are determined during a resting
condition followed by ten feedback trials of 2 minutes in length with a
one-minute break between the trials. On these feedback trials, the theta/beta
ratio is represented by a cartoon on a computer screen. This cartoon is moving
upwards when the theta/beta ratio is increasing and down when the theta/beta
ratio is decreasing, thus the child is provided with continuous feedback. The
goal is to decrease activity in the theta band and to increase activity in the
beta band (decrease the theta/beta ratio) at the vertex (electrode Cz) in order
to reach a predetermined threshold. This may be achieved by an attentive but
relaxed state. If a child reaches this threshold, positive feedback is given.
The threshold is based on baseline values in order that positive feedback will
be received about 70% of the trials. If children improve their performance, the
threshold will be set at a more difficult level in the next session. In
addition of these feedback-trials, children will also perform transfer trials,
were no continuous feedback is provided on the screen during the trial, but
only after the trial. The proportion of transfer trials will gradually increase
during the training phase. The aim of these transfer trials is to prepare for
generalization of learned activation into daily-life situations. The
neurofeedback training will consist of 30 sessions of 45 minutes (including the
attachment of electrodes), three times a week. All sessions will be supervised
by master students clinical neuropsychology, clinical psychologists and a
junior researcher, who will receive extensive training for the purpose of this
study. The sessions will be videotaped for treatment integrity checks and to
assure treatment quality.
Exercise
Exercise will include various forms of aerobic training in a fitness centre at
about 70-100% of their maximum heart rate. This is a level of exercise that has
been shown to evoke dopaminergic responses in rat (Hattori et al., 1994) and to
have effects on the catecholamine response in children with ADHD (Wigal et al.,
2003; Tantillo et al., 2001). The session will consist of series of ten 2
minutes bouts of exercise with 1 minute rest intervals between two exercise
bouts. This approach will be used because it is difficult for children to
sustain constant exercise for more than several minutes at a time. In fact,
typical bouts of exercise in children last only 25-30 seconds (Bailey et al.,
1995). The intensity of the exercise sessions will be controlled by using heart
rate monitors. The exercise regime will be comparable with the neurofeedback
training in intensity and will consist of 30 sessions of 45 minutes (including
putting on other clothes and taking a shower), three times a week, following
the well-established guidelines of an exercise regime for older adults. The
exercise sessions will also be supervised by master students clinical
neuropsychology and human movement sciences, who will receive extensive
training for the purpose of this study. The sessions will be videotaped for
treatment integrity checks and to assure treatment quality.
Methylphenidate
The children in the MPH (methylphenidate) group will be treated according to
the protocol of the ADHD outpatient unit. No additional interventions will be
provided to the children. The optimal dose will be determined through a double
blind randomised placebo controlled trial. The effects of the medication on
behaviour are being monitored by parents and teachers on questionnaires
(attention and hyperactivity scales). After five or four weeks (depending on
the child's weight), the optimal dose will be selected using standardised
algorithms (see Scheres et al., 2003). The children will receive this dose for
3 or 4 weeks followed by post assessment. See protocol for further details.
Study burden and risks
Children and parents will have to put a lot of time and effort in the study
(assessement: 3 times 4 hour, treatments, 30 sessions of 45 mintues). The
benefits are that the treatments may have a positive effect on ADHD symptoms.
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Van der Boechorststraat 1
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of ADHD.
Exclusion criteria
physical or cognitive disability
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2010-020508-31-NL |
CCMO | NL31641.029.10 |