The aim of this study is to validate whether the Daydream game conditions indeed trigger the brain activity as mentioned in the manual. In addition, it will be investigated whether playing the game induces an increase in intended brainwave activity…
ID
Source
Brief title
Condition
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The correlation between the levels within the two different conditions of the
game with the ratio of intended brainwave frequencies (derived from the EEG
assessments) that is said to be induced by these conditions.
Secondary outcome
1. The correlation between the ratio of intended brainwave activity for each
condition and the level that is reached by an individual subject in that
particular condition.
2. The correlation between number of sessions and the ratio of intended
brainwave frequencies of the two different conditions of the game.
3. Difference between baseline and follow-up session on cognitive testing.
Background summary
Patients with psychosis often suffer from anxiety and distress. A technique
that has been increasingly recognised as effective in reducing stress and
anxiety is mindfulness. Given the popularity of computer games nowadays,
mindfulness training by means of a neurofeedback game may increase the
patient*s willingness and motivation that is so frequently lacking in other
forms of therapies. Computerized interventions therefore offer promising ways
to supplement or perhaps replace more expensive face-to-face interventions.
Study objective
The aim of this study is to validate whether the Daydream game conditions
indeed trigger the brain activity as mentioned in the manual. In addition, it
will be investigated whether playing the game induces an increase in intended
brainwave activity and cognitive functioning after practice.
Study design
Longitudinal within subject design (5 measurements).
Intervention
Playing the two conditions of the Daydream game for 20 minutes (10 minutes per
condition) per session, on 5 days within a period of 2 weeks. The participant
is seated behind a computer, wearing an EEG cap (64 electrodes) and a
lightweight, wireless headset with one dry sensor on the forehead and an ear
clip attached to the earlobe. Neurofeedback is used to play the game: the
computer game reacts to the ratio of alpha and beta frequencies in the brain
activity of the player. Through continuous registration of alpha and beta ratio
by the sensor placed on the forehead the player reaches a higher or lower level
in the game.
Study burden and risks
Participants will be asked to visit the psychophysiological laboratory on 5
days within a period of maximal 2 weeks. The participant will be subject to
questionnaires, neuropsychological testing and playing the neurofeedback game
Daydream. EEG assessments are administered during the game. There is no
physical or physiological discomfort associated with participation. In
addition, there are no known risks for healthy volunteers of playing the
Daydream game or EEG measurements.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Good Physical and Mental Health meeting criteria "never mentally ill".
- Age between 18 and 45 years.
- Male.
- Written informed consent of the subject.
Exclusion criteria
- Current use of any medication;
- Any subject who has received any investigational medication within 30 days prior to the start of this study;
- History of neurologic illness;
- History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria;
- History of alcohol and drug abuse;
- Participants who are unable to understand the study outline and/or provide written informed consent;
- Participants who fail to attend less than four out of the five sessions (because this disrupts the training).
- Use of stimulants (e.g. caffeine, nicotine, drugs) 1 hour prior to the training session
Design
Recruitment
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 |
|---|---|
| CCMO | NL59464.041.16 |