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Infraslow neurofeedback for food addiction in women

Infraslow training for food craving in overweight and obese women - a double blind randomised exploratory study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000601336
Enrollment
21
Registered
2017-04-27
Start date
2017-05-15
Completion date
2017-11-01
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Dysfunctional neural activity in the cortical reward system network is implicated in food craving. Altering this pathological state using techniques of non-invasive neuromodulation may be a therapeutic option. To date, no published studies have used Infraslow neurofeedback (ISF) in the treatment of food craving among overweight and obese individuals. The aim of this study is to use ISF to target the Posterior Cingulate Cortex (PCC) as part of the default mode network (DMN) in overweight (body mass index equals to or greater than 25) or obese (body mass index equals to or greater than 30) individuals with symptoms of food-addiction (Yale Food Addiction Scale score of equals to or greater than 3) to investigate the effects on brain activity, food craving and wellbeing.

Interventions

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

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.

Sponsors

Professor Dirk de Ridder
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026