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Trial registered on ANZCTR


Registration number
ACTRN12617000601336
Ethics application status
Approved
Date submitted
24/04/2017
Date registered
27/04/2017
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Infraslow neurofeedback for food addiction in women
Scientific title
Infraslow training for food craving in overweight and obese women - a double blind randomised exploratory study
Secondary ID [1] 291761 0
Nil known
Universal Trial Number (UTN)
U1111-1194-5450
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 302986 0
food addiction 302987 0
Condition category
Condition code
Diet and Nutrition 302450 302450 0 0
Obesity
Mental Health 302451 302451 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 overweight or obese women between the ages of 18-60 years will be recruited from the community using advertisement in newspapers and on notice boards.

Those who are interested will be asked to attend a screening session at the clinic and will be provided with the participant information sheet and consent will be obtained. The researcher will screen for eligibility. If eligible, the participant will undergo an electroencephalogram (EEG) and fill out a battery of questionnaires.

Subsequently, they will be randomised and will undergo either treatment infraslow (T-ISF)(n=10) or placebo infraslow (P-ISF) (n=10) for 6 sessions, This will be administered with 3 sessions during the first week, 2 sessions in the second week and 1 session in the third week. The first session will be 10 minutes and the subsequent 5 sessions will be 20 minutes each.

During each session, participants will be asked to sit in a chair in an upright position. After careful skin preparation, the appropriate Comby EEG cap will be placed on the participant's head with reference electrodes at the mastoids. The impedance of the active electrodes will be kept below 5kilo-ohms. Before the training period, participants will be instructed to relax and listen to the sound being played. A distinct tone will be used for T-ISF reinforcement at the Posterior Cingulate Cortex (PCC). Reward threshold will be adjusted in real time at above 90%. In other words, for 90% of the time, a sound will be played (reward) when the participant's brain activity meets the infraslow magnitude (threshold). For P-ISF, the simulation protocol by Brainmaster Inc will be administered.

Both T-ISF and P-ISF infraslow sLORETA neurofeedback will be implemented with a 24 channel DC coupled amplifier produced by Brainmaster Inc at the research clinic. During the training period, participants will be sitting upright in the chair with the infraslow Comby EEG cap attached. Throughout the sessions, participants will be asked to keep their eyes open, relax and listen to the sound being played by the device.

Infraslow training will be administered by a researcher who has undergone training by Brainmaster Inc.

The researcher administering infraslow training will record the number of sessions attended. Given that this is an exploratory study, only data of participants who attend all six sessions will be analysed for primary and secondary outcomes. However, the researchers will compare baseline characteristics (wellbeing, psychological variables) of those who complete the study to those who did not. This will help inform the researchers on strategies to improve compliance if a larger clinical trial is to be conducted.
Intervention code [1] 297873 0
Behaviour
Intervention code [2] 297874 0
Lifestyle
Intervention code [3] 297893 0
Treatment: Devices
Comparator / control treatment
Control arm 1: 3 sessions of P-ISF
Control arm 2: 6 sessions of P-ISF

Comparator arm 1: 3 sessions of T-ISF
Comparator arm 2: 6 sessions of T-ISF

The T-ISF group will undergo active infraslow neurofeedback. The researchers will be comparing the effect of duration of infraslow training (3 sessions of T-ISF to 3 sessions of P-ISF and 6 sessions of T-ISF to 6 sessions of P-ISF) on brain activity and food craving.

The set-up and instructions given to participants for P-ISF will be the same to T-ISF. The simulation protocol will play the exact sound to T-ISF randomly instead of when the participant's brain activity meets the ISF magnitude.
Control group
Placebo

Outcomes
Primary outcome [1] 301863 0
Resting state activity
Functional and effective connectivity measured using EEG.
Timepoint [1] 301863 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.
Primary outcome [2] 301864 0
State/Trait Food Craving Questionnaire
A 36-item questionnaire assessing temporal and situational states of food craving on a continuous scale.
Timepoint [2] 301864 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.
Secondary outcome [1] 334138 0
Perceived Stress Scale
A 10-item continuous scale assessing the perception of stress during the last month
Timepoint [1] 334138 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.
Secondary outcome [2] 334139 0
World-Health Organization five well-being index
A 5-item continuous scale assessing aspects of wellbeing within the last 2 weeks
Timepoint [2] 334139 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.
Secondary outcome [3] 334140 0
Yale Food Addiction Scale (YFAS)
A questionnaire used to identify individuals who display signs of food addiction similar to the Diagnostic and Statistical Manual of Mental Disorder V (DSM-V) for substance addiction and YFAS score of more than three will be used as an indication of having symptoms of food addiction.
Timepoint [3] 334140 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.
Secondary outcome [4] 334141 0
Symptom checklist 90 revised
A 90-item questionnaire used to assess psychopathology, The SCL-90-R consists nine primary symptoms dimension: somatisation, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism
Timepoint [4] 334141 0
2-3 day after 3 sessions of infraslow training, 2-3 days after completion of 6 sessions of infraslow training, 2 and 4 weeks after completion of 6 sessions of infraslow training.

Eligibility
Key inclusion criteria
1. Symptoms of food addiction (scores equals to or greater than 3 on the YFAS)
2. Women aged 18-60 years
2. Being right handed
3. Overweight (BMI equals to or greater than 25) or obese (BMI equals to or greater than 30)
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Major weight gain or loss (> 5kgs) in the last 6 months
2. Certain medications
3. Recent significant head injuries. e.g. concussion where consciousness is lost or surgery
4. Psychiatric disorders with psychotic symptoms or manic symptoms
5. Other health problems-diabetes, cancer, heart disease, uncontrolled hypertension
6. Females who are or intend to become pregnant
7. History of epilepsy
8. Metal implants or implanted electronics (pacemaker)
9. Recurring headaches
10. Previous bariatric surgery
11. Previous diagnosis of an eating disorder

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)
An independent researcher from the department will seal each allocation in a consecutively numbered opaque envelope before handing them to the enrolling researcher. During enrolment and randomisation of a new participant, the enrolling researcher will write the participant's ID before opening the sealed envelope and retrieving the allocation from inside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
To ensure that sample size is balanced across the T-ISF and P-ISF groups over time, block randomisation will be applied. The independent researcher will use a validated computerised program for this purpose.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The nature of the brain activity data that is collected makes power calculations difficult and formal power calculations have not been reported in previous studies.

Our previous pilot study using transcranial pink noise stimulation showed that among 16 women (8 in sham and 8 in real treatment), after the treatment period, the real treatment group had a 22% reduction (mean decrease of 1.11, 95% CI:-2.09, -0.14, p=0.029) on the intense desire to eat sub-scale compared to the sham group. Given that we hypothesised that infraslow neurofeedback would be more efficient than transcranial pink noise stimulation, a sample size of 10 in each group will be sufficient to show a significant difference on the scale.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
1/11/2017
Date of last data collection
Anticipated
19/01/2018
Actual
1/01/2018
Sample size
Target
20
Accrual to date
Final
21
Recruitment outside Australia
Country [1] 8842 0
New Zealand
State/province [1] 8842 0
Dunedin

Funding & Sponsors
Funding source category [1] 296262 0
University
Name [1] 296262 0
University of Otago
Country [1] 296262 0
New Zealand
Primary sponsor type
Individual
Name
Professor Dirk de Ridder
Address
Department of Surgical Sciences, Neurosurgery
University of Otago
201 Great King St, Dunedin, 9016
Country
New Zealand
Secondary sponsor category [1] 295177 0
Individual
Name [1] 295177 0
Associate Professor Patrick Manning
Address [1] 295177 0
Department of Medicine,
University of Otago
201 Great King St. Dunedin, 9016
Country [1] 295177 0
New Zealand
Other collaborator category [1] 279538 0
Individual
Name [1] 279538 0
Mark Smith
Address [1] 279538 0
Neurofeedback Services of New York,
140 West 79th Street, #2B
New York, NY 10024
USA
Country [1] 279538 0
United States of America
Other collaborator category [2] 279539 0
Individual
Name [2] 279539 0
Assoc. Professor Sven Vanneste
Address [2] 279539 0
School of Behavioral and Brain Sciences,
University of Texas at Dallas,
800 W Campbell Rd, Richardson, TX 75080,
USA
Country [2] 279539 0
United States of America
Other collaborator category [3] 279540 0
Individual
Name [3] 279540 0
Dr. Theresia Stockl
Address [3] 279540 0
Pediatric Neurodevelopmental Clinic,
Bahnhofstrasse 10 /1.OG
Rear entrance
D-82131 Gauting
Germany
Country [3] 279540 0
Germany
Other collaborator category [4] 279541 0
Individual
Name [4] 279541 0
Dr Sook Ling Leong
Address [4] 279541 0
Department of Surgical Sciences, Neurosurgery
University of Otago
201 Great King St, Dunedin, 9016
Country [4] 279541 0
New Zealand
Other collaborator category [5] 279542 0
Individual
Name [5] 279542 0
Dr Joyce Lim
Address [5] 279542 0
Department of Surgical Sciences, Neurosurgery
University of Otago
201 Great King St, Dunedin, 9016
Country [5] 279542 0
New Zealand
Other collaborator category [6] 279543 0
Individual
Name [6] 279543 0
Samantha Ross
Address [6] 279543 0
Department of Medicine
University of Otago
201 Great King St, Dunedin, 9016
Country [6] 279543 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297498 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 297498 0
Ethics committee country [1] 297498 0
New Zealand
Date submitted for ethics approval [1] 297498 0
22/03/2017
Approval date [1] 297498 0
19/04/2017
Ethics approval number [1] 297498 0
17/NTB/61

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1657 1657 0 0
/AnzctrAttachments/372793-HDEC Letter 17NTB61 Approved EXP Application.pdf (Ethics approval)
Attachments [2] 1658 1658 0 0
/AnzctrAttachments/372793-ISF food addictionv3.docx (Protocol)
Attachments [3] 1659 1659 0 0
/AnzctrAttachments/372793-PIS consent version2.docx (Participant information/consent)

Contacts
Principal investigator
Name 74230 0
Prof Dirk De Ridder
Address 74230 0
Department of Surgical Sciences, Neurosurgery
201 Great King Street
Dunedin Hospital
Dunedin 9054
Country 74230 0
New Zealand
Phone 74230 0
+64 03 474 9337
Fax 74230 0
Email 74230 0
dirk.deridder@otago.ac.nz
Contact person for public queries
Name 74231 0
Sook Ling Leong
Address 74231 0
Department of Surgical Sciences, Neurosurgery
201 Great King Street
Dunedin Hospital
Dunedin 9054
Country 74231 0
New Zealand
Phone 74231 0
+64 03 474 9337
Fax 74231 0
Email 74231 0
sookling.leong@otago.ac.nz
Contact person for scientific queries
Name 74232 0
Sook Ling Leong
Address 74232 0
Department of Surgical Sciences, Neurosurgery
201 Great King Street
Dunedin Hospital
Dunedin 9054
Country 74232 0
New Zealand
Phone 74232 0
+64 03 474 9337
Fax 74232 0
Email 74232 0
sookling.leong@otago.ac.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised, double-blind, placebo-controlled parallel trial of closed-loop infraslow brain training in food addiction.2018https://dx.doi.org/10.1038/s41598-018-30181-7
N.B. These documents automatically identified may not have been verified by the study sponsor.