An interventional study of Neurofeedback in Obesity and Eating Behaviour, sponsored by University Hospital Tuebingen. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-30.
Sponsored by University Hospital Tuebingen · Not applicable, Interventional, and Treatment
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:
University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects who have a non-removable metal object in or at their body, such as, for ex-ample:
Neurofeedback training: Up-regulation of DLPFC.
Device: Neurofeedback
Neurofeedback training: Sham-regulation of DLPFC.
Device: Neurofeedback
Networks involved in eating behaviour can be modified by neurofeedback training. We will perform a neurofeedback task using the technology of fMRI-based Brain Computer Interface (BCI). BCI approaches based on real-time fMRI (rtfMRI) allow voluntary regulation of brain regions. For the rtfMRI, a well-established setup will be used which translates the blood oxygen level dependent (BOLD) signal of a specific brain region of interest into a visual signal (e.g. moving bar) in real time using brain voyager® and matlab. The study will include 1 training-sessions In the up-regulation condition subjects will learn to up regulate their dlPFC. In the sham-condition subjects are get the same instructions, however they will receive sham feedback.
Also known as: fMRI-based Brain Computer Interface (BCI), Neurofeedback training, rtfMRI
Activity in the dlPFC during the training-session
Differences in dlPFC activity between baseline and after up-regulation during the neurofeedback training session, as well as the difference between the treatment and the sham groups (ANCOVA approach).
Time frame: 1 day
Food intake
Snack consumption during the snack test, comparing pre vs post neurofeedback session, and between the two groups (ANCOVA approach).
Time frame: 4 weeks
Preferred food (healthy or unhealthy food).
Differences in food choice (healthy vs unhealthy) pre compared to post neurofeedback session and between the two groups (ANCOVA approach).
Time frame: 4 weeks
Weight
Difference in weight before and after training
Time frame: 4 weeks
Plan to share: Yes — We will share the data inside the EU-consortium
This study is status unknown, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen