Obesity Clinical Trial
Official title:
Modulating Functional Connectivity Between Eating-related Brain Areas by Neurofeedback
Neuroimaging is becoming increasingly common to investigate the neural networks underlying eating behaviour and food preference in normal-weight and obese humans. It has been observed that obese in comparison to lean individuals display altered activation patterns in networks of brain areas involved in reward, emotion and cognitive control. Interestingly, obese individuals who are capable of losing weight appear to have a stronger connectivity between areas related to food value and to the control of eating behaviour. The same areas are also associated with healthy food choices. It has been suggested that activation in the prefrontal control areas indirectly modulate valuation-related activity. Based on this, brain-related intervention strategies to support weight loss and long-lasting weight maintenance are of particular interest. Hence, we first want to examine the effect on eating behaviour of neurofeedback training-induced up-regulation of functional connectivity between reward- and impulse-related brain areas as a pilot, and second we want to examine up-regulation of the activity of prefrontal control brain areas.
Primary objective: We want to investigate whether the training-induced up-regulation of the
dorsal prefrontal cortex inhibits eating behaviour.
Study design: A parallel design. Half of the participants will learn to up-regulate activity
of the dorsolateral prefrontal cortex (dlPFC), while the other participants will participate
in sham-training sessions. Adherence to experimental conditions will be assigned randomly,
based on the participants' enrolment in the study, balanced by gender and binge eating
classification.
Study population: 50 overweight and obese (BMI 25-40 kg/m2), but otherwise healthy
individuals, 18-65 years old.
Intervention: All participants will participate in a screening day, followed by one
neurofeedback session day and a follow-up day. During the neurofeedback session,
participants will undergo a 45 min real-time-fMRI-brain-computer-interface scan in order to
learn to up-regulate dlPFC activation.
Main study parameters/endpoints:
1. The ability to up-regulate dlPFC activity.
2. Respective effects on eating behaviour. Nature and extent of the burden and risks
associated with participation: Participants will be scanned once (fMRI). Functional MRI
is a safe and non-invasive technique.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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