Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001731482
Ethics application status
Approved
Date submitted
14/12/2016
Date registered
16/12/2016
Date last updated
18/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electroencephalography (EEG) Biofeedback Training to Improve Memory for People with a Mild Memory Deficit
Scientific title
Source Localised EEG Biofeedback of the Posterior Cingulate Cortex to Improve Immediate Memory Scores in People with Mild Memory Deficit
Secondary ID [1] 290729 0
None
Universal Trial Number (UTN)
U1111-1190-8500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Memory Deficit 301306 0
Condition category
Condition code
Neurological 301060 301060 0 0
Dementias
Alternative and Complementary Medicine 301126 301126 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
15 sessions of source localised EEG biofeedback, using sLORETA, of the posterior Cingulate Cortex, designed to train up theta and alpha band frequencies, and decrease beta band frequencies. At each session, a 21 electrode EEG cap is worn by the participants, which includes 2 reference ear electrodes and a ground electrode. The 19 remaining channels produce an EEG montage referenced to the average on a laptop computer. The current density of the relevant frequency bands is calculated in real time over a four second interval, and the result displayed to the participant as the height of a vertical bar on the screen. The participant is then asked to try and keep the bar in the top half of the screen as much as possible. Each session has 30 minutes of active training with 1 minute relaxation at 5 mintues intervals thoughout. Participants complete a maximum of three and a minimum of 2 sessions a week, until they have completed 15 sessions.

15 sessions of source localised EEG biofeedback, using sLORETA, of the posterior Cingulate Cortex, designed to train up alpha band frequencies, and decrease beta band frequencies. At each session, a 21 electrode EEG cap is worn by the participants, which includes 2 reference ear electrodes and a ground electrode. The 19 remaining channels produce an EEG montage referenced to the average on a laptop computer. The current density of the relevant frequency bands is calculated in real time over a four second interval, and the result displayed to the participant as the height of a vertical bar on the screen. The participant is then asked to try and keep the bar in the top half of the screen as much as possible. Each session has 30 minutes of active training with 1 minute relaxation at 5 mintues intervals thoughout. Participants complete a maximum of three and a minimum of 2 sessions a week, until they have completed 15 sessions.

All sessions in all groups are carried out at Dunedin Hospital, supervised by a PhD student.
Intervention code [1] 296630 0
Treatment: Devices
Intervention code [2] 296686 0
Treatment: Other
Comparator / control treatment
15 sessions of sham feedback, displaying a random number generator. Each session has 30 minutes of active training with 1 minute relaxation at 5 mintues intervals thoughout
Control group
Placebo

Outcomes
Primary outcome [1] 300480 0
Change in Immediate Memory on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), assessed with a mixed effect model
Timepoint [1] 300480 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [1] 330063 0
Changes in Delayed Memory index of the RBANS, measured by a mixed effect model
Timepoint [1] 330063 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [2] 330064 0
Changes in total scale of the RBANS
Timepoint [2] 330064 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [3] 330065 0
Changes in Visuospatial index of the RBANS
Timepoint [3] 330065 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [4] 330066 0
Changes in Language index of the RBANS
Timepoint [4] 330066 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [5] 330067 0
Changes to Attention index of RBANS
Timepoint [5] 330067 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [6] 330068 0
Change in current density maps, calculated using sLORETA, from closed eyes, resting state EEG recordings
Timepoint [6] 330068 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [7] 330069 0
Change in phase lagged connectivity of the Default Mode Network, calculated using sLORETA, using closed eyed, resting state EEG recordings
Timepoint [7] 330069 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [8] 330070 0
Change in current density of the posterior cingulate cortex, in the theta frequency band, assessed using sLORETA
Timepoint [8] 330070 0
The first 5 minutes and last 5 minutes of each of the 15 biofeedback sessions, plotted over time
Secondary outcome [9] 330072 0
Change in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal gyrus in the theta frequency band, using sLORETA
Timepoint [9] 330072 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [10] 330073 0
Factor analysis correlating changes in cognitive scores on the RBANS to changes in the current density of the posterior cingulate cortex, assessed using sLORETA
Timepoint [10] 330073 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [11] 330074 0
Seed point analysis of phase lagged synchronisation of the Posterior Cingulate Cortex to the rest of the brain, assessed using sLORETA
Timepoint [11] 330074 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [12] 330089 0
Current Density in the Default Mode Network, assessed using sLORETA
Timepoint [12] 330089 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session
Secondary outcome [13] 330249 0
Change in current density of the posterior cingulate cortex, in the alpha 1 frequency band, assessed using sLORETA
Timepoint [13] 330249 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [14] 330250 0
Change in current density of the posterior cingulate cortex, in the alpha 2 frequency band, assessed using sLORETA
Timepoint [14] 330250 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [15] 330251 0
Change in current density of the posterior cingulate cortex, in the beta frequency band, assessed using sLORETA
Timepoint [15] 330251 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [16] 330252 0
Change in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal gyrus in the alpha 1 frequency band, using sLORETA
Timepoint [16] 330252 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [17] 330253 0
Change in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal gyrus in the alpha 2 frequency band, using sLORETA
Timepoint [17] 330253 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [18] 330254 0
Change in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal gyrus in the beta frequency band, using sLORETA
Timepoint [18] 330254 0
The first 5 minutes and last 5 minutes of each of the biofeedback training sessions, plotted over time
Secondary outcome [19] 330255 0
Factor analysis correlating changes in cognitive scores on the RBANS to changes in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal cortex,
Timepoint [19] 330255 0
Change from baseline to immediately following the completion of all training sessions, and at 6 weeks following the final session

Eligibility
Key inclusion criteria
Score below 90 on the immediate memory index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants must be free of significant neurological or psychiatric disease. Mild depression or anxiety is permitted.
Participants who score below 21/30 on the Mini Mental State Examination are excluded from the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will be using a block randomisation design, stratified by sex, and stratified by cholinesterase inhibitor use independently.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be recruiting 60 participants into the biofeedback study. With 20 participants in each arm, there will be an 80% power of detecting a statistically significant difference of 11 points on the RBANS immediate memory score. This represents a clinically significant change in the participant’s memory score. If recruitment was reduced and only 15 participants were recruited into each arm, there is an 80% chance of detecting a difference of 13 on the RBANS immediate memory score. This again would represent a clinically significant difference. Our preliminary data analysis from pilot data indicates that there is an increase in the RBANS immediate memory score of 14 points as a result of biofeedback training.


We will perform repeated t-tests for each group separately to compare the pre training RBANS scores to the post training RBANS scores. Also, compare the pre training RBANS scores to the 6-week follow up scores.
With in each group separately, use permutation testing within the sLORETA program to find the significant changes in the post training resting EEG compared to the pre training resting EEG in the current density maps, whole brain connectivity and default mode network connectivity.
Similarly, within each group separately compare the 6 week follow up EEG to the pre training EEG.
We will then assess for significant trends within each group in the in training data and resting state data, specifically assessing the correlation coefficient of change in current density and change in phase lagged synchronisation of the PCC and parahippocampal gyrus.
The significance of changes in RBANS test scores and cognitive indices between the baseline, post training, and 6 week follow up will be assessed using a mixed effect model.
Using permutation testing within the sLORETA program, compare the change in current density maps, whole brain connectivity and default mode network connectivity from pre training to post testing between groups. The following comparisons were planned, broadband feedback group to sham, narrow band feedback to sham, and broadband feedback to narrowband feedback.
We will use a factor analysis to compare the changes in cognitive score on the RBANS to the changes in the current density in the posterior cingulate cortex and changes in the phase lagged synchronisation of the posterior cingulate cortex to the parahippocampal gyrus.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/01/2016
Date of last participant enrolment
Anticipated
Actual
17/11/2016
Date of last data collection
Anticipated
27/01/2017
Actual
27/01/2017
Sample size
Target
60
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 8476 0
New Zealand
State/province [1] 8476 0

Funding & Sponsors
Funding source category [1] 295159 0
Other Collaborative groups
Name [1] 295159 0
Brain Research New Zealand
Country [1] 295159 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Dunedin School of Medicine
Address
Dunedin School of Medicine,
PO Box 56
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 293982 0
None
Name [1] 293982 0
Address [1] 293982 0
Country [1] 293982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296514 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 296514 0
Ethics committee country [1] 296514 0
New Zealand
Date submitted for ethics approval [1] 296514 0
09/12/2015
Approval date [1] 296514 0
15/12/2015
Ethics approval number [1] 296514 0
H15/127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71110 0
Dr Nick Cutfield
Address 71110 0
Department of Medicine,
Dunedin School of Medicine,
University of Otago,
PO Box 56,
Dunedin 9054
Country 71110 0
New Zealand
Phone 71110 0
+64 3 4740999 ext 7297
Fax 71110 0
Email 71110 0
[email protected]
Contact person for public queries
Name 71111 0
Timothy Galt
Address 71111 0
Department of Medicine,
Dunedin School of Medicine,
University of Otago,
PO Box 56,
Dunedin 9054
Country 71111 0
New Zealand
Phone 71111 0
+64 22 1052320
Fax 71111 0
Email 71111 0
[email protected]
Contact person for scientific queries
Name 71112 0
Timothy Galt
Address 71112 0
Department of Medicine,
Dunedin School of Medicine,
University of Otago,
PO Box 56,
Dunedin 9054
Country 71112 0
New Zealand
Phone 71112 0
+64 221052320
Fax 71112 0
Email 71112 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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