ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

U1111-1194-5450

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

obesity

food addiction

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

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]

Behaviour

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Resting state activity
Functional and effective connectivity measured using EEG.

Timepoint [1]