Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02572180
Status:
UNKNOWN
Last Update Posted:
2016-06-24
First Post:
2015-10-07
Brief Title:
A Biofeedback Training in Schoolchildren With an Attention-DeficitHyperactivity Disorder ADHD
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
A Biofeedback Training in Schoolchildren With an Attention-DeficitHyperactivity Disorder ADHD Differential Effects of Training in a 2D or 3D Environment
Status:
UNKNOWN
Status Verified Date:
2016-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims towards investigating the efficacy of a near-infrared spectroscopy NIRS-based neurofeedback training in a virtual reality VR classroom in schoolchildren with attention-deficithyperactivity disorder ADHD The investigators are especially interested in the trainings impact on academic performance executive functioning EF and behavioral ADHD symptoms Furthermore the investigators aim at examining the influence of teachers instructional behavior on children with ADHDs learning in a short virtual reality classroom scenario Several studies provide evidence that poor academic achievement in ADHD is mainly due to impairments in EF and ADHD behavior eg Frazier Youngstrom Glutting Watkins 2007 Miller et al 2013 Furthermore studies show that these factors are related to neurophysiological characteristics found in electroencephalographic EEG or functional NIRS fNIRS examinations eg Barry Clarke Johnstone 2003 Barry Johnstone Clarke 2003 Loo Barkley 2005 Negoro et al 2010 Neurofeedback trainings aim at improving these neurophysiological as well as cognitive-behavioral deficits Gevensleben Moll Rothenberger Heinrich 2014 and are expected to improve academic performance in children with ADHD accordingly Training in a VR classroom from the investigators perspective facilitates generalization of self-regulation competences to real-life academic situations and at the same time increases the effort invested into the training compared to a training in 2D settings Consequently training in a VR classroom is hypothesized to lead to greater improvement in academic performance EF and a greater decrease of ADHD symptoms than a training in a 2D setting Moreover the investigators hypothesize that these effects are more pronounced in children who receive a NIRS-based neurofeedback training compared to children receiving a biofeedback training based on an electromyogram EMG
Detailed Description:
1 Strategies 90 schoolchildren from Grade 1 to 4 that meet criteria for a DSM-V diagnosis of ADHD any presentation will be recruited The design will involve three groups n 30 per group N 90 to which recruited children will be assigned randomly but matched for age gender and medication In addition to VR NIRS NF and VR EMG biofeedback groups a third group will experience the NIRS NF in the exact same 2D classroom environment
2 The Study 21 Testing Protocol Informed consent discussion Parents of children pre-diagnosed with ADHD will not undergo a screening process However parents whose children have not been pre-diagnosed with ADHD before will be provided with the German version of the Conners-3 parent ADHD-Index C3-AI Only if the screening indicates that the child is at an increased risk of having ADHD will the investigators proceed with an informed consent discussion If the screening indicates that it is unlikely that the child has ADHD the investigators will exclude the child from the study After the meeting if the child was either pre-diagnosed with ADHD before or the screening indicates an increased likelihood for the child to have ADHD parents will have enough time to think about whether they want to give written informed consent to participate in the study
If parents give written informed consent the next step will be a session in which the ADHD diagnosis is verified For this session parents will be informed about three opportunities
1 Diagnostic session in the scope of their participation in a second study at the pediatric clinic in Tübingen at the same time that they participate in our biofeedback study This study is called Aufmerksamkeit und Kognition bei Kindern mit Neurofibromatose Typ 1 which is still searching for children with ADHD only without neurofibromatosis type 1 to form a control group
2 Diagnostic session in the scope of the Spezialsprechstunde ADHS in the outpatient clinic of the department of child and adolescence psychiatry
3 Diagnostic session within the scope of this biofeedback study as described below
Diagnostic session For a standardized confirmation as well as a characterization of the diagnosis the long versions of the Conners-3 parent and teacher rating scales 3-P and 3-T will be applied Furthermore the German version of the Strengths- and Difficulties Questionnaire SDQ-Deu is going to assess the severity of the symptoms as well as comorbidities from class teacher as well as parental perspective In order to assess the actual quality of life of parents and child parents and children will be asked to fill out the Kiddy-Kindl in its appropriate version Moreover surrounding variables such as medication prior treatment other clinical diagnoses etc will be assessed with a questionnaire As neuropsychological variables intelligence will be assessed using the short version of the Culture Fair Test CFT 1-R or CFT 20-R
Pre-Test
Session 1 of the pre-test is going to assess executive functions of the participants and requires a washout of methylphenidate MPH as well as amphetamines MPH and amphetamines should be washed out for at least 48 hours over the weekend so that the pre-test can take place on Mondays Atomoxetine does not need any washout as the effects of medication are not directly related to the drug level in the blood In this first session a combined EEGNIRS-measurement will take place as the investigators would like to provide information about whether changes caused by the BF intervention are also reflected in changes that can be measured with EEG and NIRS during the following tasks a GoNo-Go Task 10 min a verbal fluency task 10 min and an n-back task 10 min Furthermore the participants performance on a digit span task forward backward 10 min will assess verbal WM whereas a matrices span task 15 min and the Corsi Block Tapping Task forward backward 10 min will assess visual-spatial WM performance Inhibition will be once more assessed using the Stop Signal Task 10 min
Session 2 without medication washout will assess academic performance using one of the appropriate DEMAT 1-4 20-40 Min assessing mathematical performance and the SLRT-II 25-35 Min assessing reading and writing performance Furthermore sustained attention will be assessed with the Conners CPT 15 min Questionnaires assessing self-control and academic self-efficacy will be filled out by the children ca 20 min
Furthermore an accelerometer that is worn on the non-dominant side of the body hip attached to the waistband with a light belt for ten consecutive days will objectively assess motor hyperactivity During this time parents will be called once per day to assess ADHD symptoms with the Global Index ADHD ADHS-GI and to check whether the accelerometer is worn and works
Parents and teachers will be asked to fill out the BRIEF as well as the SDQ-Deu the long versions of the Conners-3 parent and teacher rating scales 3-P and 3-T and the Kiddy-Kindl Moreover the investigators will ask the parents to fill out an adapted version of the FERT as well as an adapted version of the brief self-control scale in order to assess their expectancies of the training
Midway-Test After eight sessions participants will have a break of two to three weeks in which no NF or BF training takes place ADHD behavior will be assessed by asking parents as well as teachers to fill out the Conners 3-P 3-T
Post-Test The post-test will follow the procedure already applied in the pre-test
Follow-Up-Test 6 months after the last training session The Follow-Up-Test will follow the course of the post-test exactly
Every session During every session the investigators will assess the participants motivation with a short questionnaire measuring joy effort and enthusiasm Furthermore heart rate variability HRV will be recorded as it has been shown to be related to motivational processes Accelerometer data from knee and wrist will be recorded to examine hyperactive behavior
22 Training Plan and Protocol The NIRS- and EMG-based NF and BF training protocols of this study will include 15 training sessions in total two to three per week Every training session will last about 60 minutes including the biofeedback training itself and a preparation phase at the beginning in which the NIRS cap and its optodes are fitted to the head in the case of a NF training or the EMG electrodes are placed above both Musculi supraspinatus in the case of a BF training Furthermore the head-mounted display HMD for the VR is mounted in the VR 3D classroom groups only
Every training session with NIRS- and EMG-based NFBF consists of three runs of which the first and the second are with continuous performance feedback feedback condition In the third run no feedback is provided transfer condition Lighting in the 3D VR or 2D classroom increases with activation and decreases with deactivation During the first eight training sessions the training will follow a protocol with 50 activation and 50 deactivation trials For the second half of the training sessions the protocol will change to 80 activation and 20 deactivation trials
After eight sessions participants will have a two to three week break that aims at further supporting transfer to a real-life setting by using stimulus cards with screenshots of the training setting and instructions to practice activation and deactivation at home on a daily basis The stimulus cards show the image of the classroom participants see during the training and will be introduced in the laboratory setting directly after the training sessions 6 7 and 8 That means with the help of these cards and while looking at them participants should practice brain or muscular activation several times depending on whether they belong to the NIRS-NF or EMG-BF group like they learned in the training ie they should imagine to increase the lighting in the room when looking at the stimulus cards for two to four minutes After this activation task they solve some mathematical tasks or riddles matching their age and knowledge In the second half of the training sessions after the break participants are asked to continue practicing activation at home before doing their homework as well as in other situations requiring attention
23 Experimental Paradigm Participants that receive a NIRS-based NF training have to increase the BOLD signal activation or decrease it accordingly deactivation Analogously participants in the BF training condition will have to increase and decrease muscular activity measured with EMG Every session consists of three runs In the first and the second run contingent performance feedback is provided but no feedback is given in the third run Feedback will be provided to the participants via a continuous change of the lighting within the room the room will brighten with increasing activation and dim with increasing deactivation Additional feedback from an animated teacher as well as a scoreboard will provide them with positive reinforcement at the end of every trial
Visual auditory and mixed distractors such as for instance paper planes flying through the room fellow students whispering or people knocking on the door and coming into the room will be introduced in every run from the fourth training session onwards The distractors appear with a distance of at least 60 seconds between two distractors
The baseline of the first second and third run will be calculated from the BOLD signal in the last two seconds before the trigger arrow appears Reinforcement will be provided with 1 smiley when the participant spent 60 of the time of the second half of the trial on the required side of the baseline ie below if deactivation is required or above if activation is required Analogously he she will receive 2 smileys with 70 and 3 smileys with 80 of the second half of the trial in the required direction Reinforcement for the second run changes adaptively with the performance in the first run If the participant scored between 40-60 success rate getting at least 1 smiley the second block will remain exactly like the first If the participant scores lower than 40 success rate the threshold will decrease to 08 standard deviations STD in either direction relative to the baseline so that the normalization of the light makes it more sensitive to performance In addition the threshold for getting a smiley would decrease to 50 60 and 70 for one two or three smileys respectively If the participant scores higher than 60 success rate in the first run then the threshold would increase to 12 STD above and below the baseline In addition the percent of time that is spent above the baseline or below the baseline would need to be 01 STD above or below the baseline to count towards the overall percentage The third run is the same as the second in calculation
2 The Study 21 Testing Protocol Informed consent discussion Parents of children pre-diagnosed with ADHD will not undergo a screening process However parents whose children have not been pre-diagnosed with ADHD before will be provided with the German version of the Conners-3 parent ADHD-Index C3-AI Only if the screening indicates that the child is at an increased risk of having ADHD will the investigators proceed with an informed consent discussion If the screening indicates that it is unlikely that the child has ADHD the investigators will exclude the child from the study After the meeting if the child was either pre-diagnosed with ADHD before or the screening indicates an increased likelihood for the child to have ADHD parents will have enough time to think about whether they want to give written informed consent to participate in the study
If parents give written informed consent the next step will be a session in which the ADHD diagnosis is verified For this session parents will be informed about three opportunities
1 Diagnostic session in the scope of their participation in a second study at the pediatric clinic in Tübingen at the same time that they participate in our biofeedback study This study is called Aufmerksamkeit und Kognition bei Kindern mit Neurofibromatose Typ 1 which is still searching for children with ADHD only without neurofibromatosis type 1 to form a control group
2 Diagnostic session in the scope of the Spezialsprechstunde ADHS in the outpatient clinic of the department of child and adolescence psychiatry
3 Diagnostic session within the scope of this biofeedback study as described below
Diagnostic session For a standardized confirmation as well as a characterization of the diagnosis the long versions of the Conners-3 parent and teacher rating scales 3-P and 3-T will be applied Furthermore the German version of the Strengths- and Difficulties Questionnaire SDQ-Deu is going to assess the severity of the symptoms as well as comorbidities from class teacher as well as parental perspective In order to assess the actual quality of life of parents and child parents and children will be asked to fill out the Kiddy-Kindl in its appropriate version Moreover surrounding variables such as medication prior treatment other clinical diagnoses etc will be assessed with a questionnaire As neuropsychological variables intelligence will be assessed using the short version of the Culture Fair Test CFT 1-R or CFT 20-R
Pre-Test
Session 1 of the pre-test is going to assess executive functions of the participants and requires a washout of methylphenidate MPH as well as amphetamines MPH and amphetamines should be washed out for at least 48 hours over the weekend so that the pre-test can take place on Mondays Atomoxetine does not need any washout as the effects of medication are not directly related to the drug level in the blood In this first session a combined EEGNIRS-measurement will take place as the investigators would like to provide information about whether changes caused by the BF intervention are also reflected in changes that can be measured with EEG and NIRS during the following tasks a GoNo-Go Task 10 min a verbal fluency task 10 min and an n-back task 10 min Furthermore the participants performance on a digit span task forward backward 10 min will assess verbal WM whereas a matrices span task 15 min and the Corsi Block Tapping Task forward backward 10 min will assess visual-spatial WM performance Inhibition will be once more assessed using the Stop Signal Task 10 min
Session 2 without medication washout will assess academic performance using one of the appropriate DEMAT 1-4 20-40 Min assessing mathematical performance and the SLRT-II 25-35 Min assessing reading and writing performance Furthermore sustained attention will be assessed with the Conners CPT 15 min Questionnaires assessing self-control and academic self-efficacy will be filled out by the children ca 20 min
Furthermore an accelerometer that is worn on the non-dominant side of the body hip attached to the waistband with a light belt for ten consecutive days will objectively assess motor hyperactivity During this time parents will be called once per day to assess ADHD symptoms with the Global Index ADHD ADHS-GI and to check whether the accelerometer is worn and works
Parents and teachers will be asked to fill out the BRIEF as well as the SDQ-Deu the long versions of the Conners-3 parent and teacher rating scales 3-P and 3-T and the Kiddy-Kindl Moreover the investigators will ask the parents to fill out an adapted version of the FERT as well as an adapted version of the brief self-control scale in order to assess their expectancies of the training
Midway-Test After eight sessions participants will have a break of two to three weeks in which no NF or BF training takes place ADHD behavior will be assessed by asking parents as well as teachers to fill out the Conners 3-P 3-T
Post-Test The post-test will follow the procedure already applied in the pre-test
Follow-Up-Test 6 months after the last training session The Follow-Up-Test will follow the course of the post-test exactly
Every session During every session the investigators will assess the participants motivation with a short questionnaire measuring joy effort and enthusiasm Furthermore heart rate variability HRV will be recorded as it has been shown to be related to motivational processes Accelerometer data from knee and wrist will be recorded to examine hyperactive behavior
22 Training Plan and Protocol The NIRS- and EMG-based NF and BF training protocols of this study will include 15 training sessions in total two to three per week Every training session will last about 60 minutes including the biofeedback training itself and a preparation phase at the beginning in which the NIRS cap and its optodes are fitted to the head in the case of a NF training or the EMG electrodes are placed above both Musculi supraspinatus in the case of a BF training Furthermore the head-mounted display HMD for the VR is mounted in the VR 3D classroom groups only
Every training session with NIRS- and EMG-based NFBF consists of three runs of which the first and the second are with continuous performance feedback feedback condition In the third run no feedback is provided transfer condition Lighting in the 3D VR or 2D classroom increases with activation and decreases with deactivation During the first eight training sessions the training will follow a protocol with 50 activation and 50 deactivation trials For the second half of the training sessions the protocol will change to 80 activation and 20 deactivation trials
After eight sessions participants will have a two to three week break that aims at further supporting transfer to a real-life setting by using stimulus cards with screenshots of the training setting and instructions to practice activation and deactivation at home on a daily basis The stimulus cards show the image of the classroom participants see during the training and will be introduced in the laboratory setting directly after the training sessions 6 7 and 8 That means with the help of these cards and while looking at them participants should practice brain or muscular activation several times depending on whether they belong to the NIRS-NF or EMG-BF group like they learned in the training ie they should imagine to increase the lighting in the room when looking at the stimulus cards for two to four minutes After this activation task they solve some mathematical tasks or riddles matching their age and knowledge In the second half of the training sessions after the break participants are asked to continue practicing activation at home before doing their homework as well as in other situations requiring attention
23 Experimental Paradigm Participants that receive a NIRS-based NF training have to increase the BOLD signal activation or decrease it accordingly deactivation Analogously participants in the BF training condition will have to increase and decrease muscular activity measured with EMG Every session consists of three runs In the first and the second run contingent performance feedback is provided but no feedback is given in the third run Feedback will be provided to the participants via a continuous change of the lighting within the room the room will brighten with increasing activation and dim with increasing deactivation Additional feedback from an animated teacher as well as a scoreboard will provide them with positive reinforcement at the end of every trial
Visual auditory and mixed distractors such as for instance paper planes flying through the room fellow students whispering or people knocking on the door and coming into the room will be introduced in every run from the fourth training session onwards The distractors appear with a distance of at least 60 seconds between two distractors
The baseline of the first second and third run will be calculated from the BOLD signal in the last two seconds before the trigger arrow appears Reinforcement will be provided with 1 smiley when the participant spent 60 of the time of the second half of the trial on the required side of the baseline ie below if deactivation is required or above if activation is required Analogously he she will receive 2 smileys with 70 and 3 smileys with 80 of the second half of the trial in the required direction Reinforcement for the second run changes adaptively with the performance in the first run If the participant scored between 40-60 success rate getting at least 1 smiley the second block will remain exactly like the first If the participant scores lower than 40 success rate the threshold will decrease to 08 standard deviations STD in either direction relative to the baseline so that the normalization of the light makes it more sensitive to performance In addition the threshold for getting a smiley would decrease to 50 60 and 70 for one two or three smileys respectively If the participant scores higher than 60 success rate in the first run then the threshold would increase to 12 STD above and below the baseline In addition the percent of time that is spent above the baseline or below the baseline would need to be 01 STD above or below the baseline to count towards the overall percentage The third run is the same as the second in calculation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None