Idiographic study of Neurofeedback to Ameliorate Mood in the Elderly (i-NAME); A pilot study with six patients.

EEG Neurofeedback training is an innovative and promising intervention for the
treatment of psychiatric disorders associated with dysfunctional brain
activity. EEG Neurofeedback training (NF) is able to change brain perfusion and
metabolism, and more specific cortical excitability. Most evidence is available
in the treatment of Attention Deficit Hyperactivity Disorder in adolescence, in
which NF appeared a feasible and cost-effective treatment. Depressed patients
show relative hypoactivation in the left prefrontal area, which differs from
that found in normal people who show relative hyperactivation in the left
prefrontal area. Neurofeedback training is hypothesised as a promising
treatment for alleviating depressive symptoms by modulating this disbalance in
frontal alpha activity. Some case studies as well as a randomised controlled
pilot study showed that a relative increase in right frontal alfa-activity by
an asymmetric neurofeedback training diminishes depressive symptoms. Whether
change in (balance of right-left) prefrontal cortical activity underlies this
improvement has to proven yet. In other words, it has to be proven whether a
change in frontal alpha-symmetry precedes or follows an improvement of
depressive symptoms.

Application of neurofeedback training requires frequent training sessions
guided by clinicians. Consequently, the intervention is expensive limiting
accessibility in routine clinical care. This has stimulated the development of
methods enabling patients to train themselves in their natural environment (at
home) at relatively low costs. This is especially relevant for older and less
mobile patients. Recently, we have developed a neurofeedback device giving
feedback by a tablet app enabling training at home. This device and training
procedures were tested and considered feasible by non-depressed persons.
Further testing of feasibility among depressed older persons, however, is
needed before application in a large-scale randomised controlled trial.

The primary objective of the present pilot study is:
1. To evaluate the temporal dynamics between neurofeedback parameters and
depressive symptoms in older persons suffering from clinically relevant
depressive symptoms.

The secondary objectives are:
2. To test the feasibility of EEG neurofeedback training in older persons
suffering from clinically relevant depressive symptoms with the aid of a tablet
application,
3. To evaluate the feasibility of a test battery that can be applied in larger,
randomised controlled trials in case this pilot study is deemed successful.

We will use an idiographic study design, which focuses on individual patients,
with multiple repeated measures. In total, 6 participants aged >=60 years with
clinically relevant depressive symptoms will be studied during daily
neurofeedback exercises in their home environment for 56 consecutive days.
Before and after the daily neurofeedback exercises patients will fill in a
diary, which consists of 23 visual analogues scales regarding mood symptoms.

Previous studies have shown that depressed older persons are capable of
neurofeedback training as well as administration of a questionnaire to assess
mood symptoms on a daily basis.

Using time-series analysis the temporal relationship between
neurofeedback-induced changes in alpha-lateralisation and depressive symptoms
will be evaluated on an individual patient level.

There are no risks involved in participating in the study. Previous studies on
neurofeedback training in depressie did not reveal any side-effects.
Nonetheless, neurofeedback training in other psychiatric disorder do report
headache and tiredness.

The burden of participating in the study consists of: 1) baseline assessments
(filling out questionnaires), 2) undergo the 56-day study-period during which
participants fill out the daily visual analogue scales (23 items) and undergo a
NF session on a daily basis, 3) fill out a psychopathology battery of
questionnaires for four times (at baseline, after 4, 8 and 12 weeks), 4) hand
in devices and fill out questionnaire to assess feasibility and burden of NF
training and study procedures.

Benefits for the participants may include an improvement in depressive symptoms
due to the NF training.