The aim of the present pilot study is to obtain insight in the attainability of a study investigating the effectiveness of NeuroCARE NFT in more than average stressed but otherwise healthy young adults, using the current design. The claims that…
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Brief title
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- Other condition
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Health condition
Het heeft niet betrekking op mensen met een aandoening: gezonde vrijwilligers die meer dan gemiddeld gestresst zijn maar verder gezond, zijn de doelgroep
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate stress, sleep, cognitive function and
mood in a group of more than average stressed healthy subjects undergoing an 8
week NeuroCARE NFT program or a placebo program.
The following assessments will be performed:
(1) Assessment of stress
* Objective stress level, measured by Heart Rate Variability (standarddeviation
of RR-intervalls and intensity of the HF component of the ECG spectrum will be
analyzed)
* Subjective stress level, measured by POMS short form and a stress rating scale
(2) Assessment of sleep
* Objective sleep-assessment with SenseWear PRO2 Body Monitoring System
* Subjective sleep-assessments with a sleep log and a Dutch translation of the
Karolinksa Sleepiness Scale (KSS)
(3) Mood
Measured by POMS short form
(4) Cognitive function
Measures of:
* declarative long term memory (CVLT)
* selective attention (D2 concentration test)
* working memory (calculations, Digit Symbol - Coding WAIS III)
* executive function (Stroop Colour Word Test, Letter Fluency test)
Secondary outcome
n.a.
Background summary
Neurofeedback training (NFT) is an operant conditioning paradigm through which
participants can learn to influence parameters of their electrical brain
activity, as measured by the electroencephalogram (EEG), through (audio or
visual) feedback of their brain activity. The EEG-feedback is used to reinforce
the desired electrical brain response.
Some successes with NFT have been reported in enhancing functioning in healthy
volunteers and in lessening complaints in neuropsychiatric patients. However,
because thorough controlled studies on NFT in healthy volunteers are lacking,
there is still no consesus considering the effectiveness of NFT.
The Canada based Zengar institute has developed a new NF apparatus called
NeuroCARE. In several countries, including the Netherlands, people without
medical or scientific training offer NeuroCARE NFT and make profit out of *the
treatment* of psychiatric patients and healthy people with this technique. It
is claimed by these practitioners that the NeuroCARE NFT is effective in
reducing symptoms in a wide variety of psychiatric disorders and in improving
functioning of healthy persons.
In the manual of the NeuroCARE course it is claimed explicitlly that the
programm is effective in (1) reducing stress, (2) improving mood (3) improving
sleep, and (4) inproving cognitive functioning in healthy volunteers.
To our knowledge the effectiveness of the NeuroCARE NFT has never been studied.
We would like to investigate whether NeuroCARE NFT is indeed effective on the
afore mentioned points. The current pilot study is especially aimed at the
attainability of a study on the effectiveness of NeuroCARE NFT.
Study objective
The aim of the present pilot study is to obtain insight in the attainability of
a study investigating the effectiveness of NeuroCARE NFT in more than average
stressed but otherwise healthy young adults, using the current design. The
claims that NeuroCARE NFT will lead to improvements in (1) relaxation (2) mood
(3) cognitive performance and (4) sleep will be tested in a double blind
equivalent sham control group design experiment. We hope to invetigate this
more thoroughly in a possible continuation study.
Study design
This is a double blind randomised experiment. Subject will be randomly assigned
to:
1) a group receiving real NeuroCARE NFT
or
2) a group receivin mock NeuroCARE NFT
Subject will get 16 NF sessions of 1 hour each. Subject and staff conducting
the dependent measurements (testers) are blind for study condition. The trainer
is not blind, but does not conduct any dependent measures. Furthermore, the
trainers' behaviour, communication between trainer and subject an between
trainer and tester will be strandardised.
On different points in time , measures of stress, mood, sleep and conitive
functioning wil be obtained (before and after, and some during the complete
training programm).
We will analyse whether the 'real NFT group' will show greater improvement on
the above mentioned measures than the 'mock NFT group'.
Intervention
Subjects receive 16 sessions of neurofeedback training of 40 minutes each.
During NFT, Subject will be placed in a chair in supine position by the
assistant in a dimly lit room. The subject is connected to the NF equipment
with 2 EEG electrodes and listens to his or her favourite music for 40 minutes.
NeuroCARE software gives feedback by short interruptions of the music. With
this feedback, it is claimed that brainactivity can be influenced and
alterations on psycho(phisio)logical level can be realized.
Study burden and risks
Subjects will be asked to follow a 8 week during NF programm. During this
period, subjects will have to come to the hospital twice a week for about an
hour. Furthermore, they will be asked to wear the Sensewear sleepmonitor for 5
consecutive nights an to fill out a sleep log for 5 days.
The total time-investment that will be asked of the subjects amounts to about
18 1/2 hours. No invasive measurements will be done. The financial compensation
amouts to 315 euros (¤17,50 per visit). Participation in the study does not
lead to any direct risks. At the most, subject could feel a little tired
temporary during a neurofeedback session.
High Tech Campus 34; 5656 AE Eindhoven
Postbox WB 41 Eindhoven
Nederland
High Tech Campus 34; 5656 AE Eindhoven
Postbox WB 41 Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
1) A score of at least 1 standard deviation above the reported mean of the Perceived Stress Questionnaire
2) 18 - 30 years old
3) Written informed consent
Exclusion criteria
1) Evidence of a significant psychiatric (e.g. sleep disorder or major depression), neurological (e.g. epilepsy) or other medical (particularly cardiovascular and adrenocortical) disorder at the time of inclusion
2) Pregnancy at the time of inclusion (based on the subjective report of the subject)
3) The excessive use of medication, particularly corticosteroid medication at the time of inclusion
4) Significant alcohol abuse at the time of inclusion
5) An education level that is lower than high school
6) With occurrence of certain medical diseases (for example fever) a subject can be temporarily be excluded from the intervention
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 | NL17397.041.07 |