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Trial record 6 of 155 for:    neurofeedback

The Effect of Neurofeedback on Eating Behaviour

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ClinicalTrials.gov Identifier: NCT02148770
Recruitment Status : Unknown
Verified June 2015 by University Hospital Tuebingen.
Recruitment status was:  Recruiting
First Posted : May 28, 2014
Last Update Posted : May 30, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Eating Behaviour Device: Neurofeedback Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Modulating Functional Connectivity Between Eating-related Brain Areas by Neurofeedback
Study Start Date : November 2014
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: Neurofeedback
Neurofeedback training: Up-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.
Other Names:
  • fMRI-based Brain Computer Interface (BCI)
  • Neurofeedback training
  • rtfMRI

Sham Comparator: Neurofeedback SHAM
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.
Other Names:
  • fMRI-based Brain Computer Interface (BCI)
  • Neurofeedback training
  • rtfMRI




Primary Outcome Measures :
  1. Activity in the dlPFC during the training-session [ Time Frame: 1 day ]
    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).


Secondary Outcome Measures :
  1. Food intake [ Time Frame: 4 weeks ]
    Snack consumption during the snack test, comparing pre vs post neurofeedback session, and between the two groups (ANCOVA approach).

  2. Preferred food (healthy or unhealthy food). [ Time Frame: 4 weeks ]
    Differences in food choice (healthy vs unhealthy) pre compared to post neurofeedback session and between the two groups (ANCOVA approach).

  3. Weight [ Time Frame: 4 weeks ]
    Difference in weight before and after training



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female subjects
  • Age 18-65 years at start of the study
  • Body Mass Index (BMI) between 25 and 40 kg/m2
  • Informed consent to study protocol
  • Willingness to be informed about chance findings of pathology and approval of the disclosure of this information to the general physician (see Informed Consent)
  • Fulfilment of the criteria for blood donors according to the "Richtlinien zur Gewinnung von Blut und Blutbestandteilen und zur Anwendung von Blutprodukten", in particular Hb ≥ 135 g/l (8,37 mmol/l; Bundesärztekammer 2010)

Exclusion Criteria:

  • Subjects who have a non-removable metal object in or at their body, such as, for ex-ample:

    • Heart pace-maker
    • Artificial heart valve
    • Metal prosthesis
    • Metallic implants (screws, plates from operations, etc.)
    • Metal splinters / grenade fragments
    • Non-removable dental braces
    • Acupuncture needles
    • Insulin pump
    • Intraport, etc.
    • In field strengths of over 1.0 T also: tattoos, eye lid-shadow
  • Current weight loss regimens
  • Limited temperature perception and/or increased sensitivity to warming of the body
  • Pathological hearing ability or an increased sensitivity to loud noises
  • Claustrophobia
  • Lack of ability to give informed consent
  • Operation less than three month ago
  • Simultaneous participation in other studies
  • Acute illness or infection during the last 4 weeks
  • Neurological disorder or injury
  • Moderate or severe head injury
  • Severe psychotic illness
  • Intake of antidepressants / antipsychotics
  • Participation in other studies with blood withdrawals or blood donation in previous and subsequent 2 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148770


Contacts
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Contact: Manfred Hallschmid, PhD +49 7071 29-8825 Manfred.Hallschmid@uni-tuebingen.de
Contact: Maartje Spetter, PhD +49 7071 29-81193 Maartje.Spetter@uni-tuebingen.de

Locations
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Germany
UKT and MPI Recruiting
Tuebingen, Germany, 72076
Contact: Manfred Hallschmid, PhD    +49 7071 29-8825    Manfred.Hallschmid@uni-tuebingen.de   
Sub-Investigator: Maartje Spetter, PhD         
Principal Investigator: Manfred Hallschmid, PhD         
Sub-Investigator: Ralf Veit, PhD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Manfred Hallschmid, PhD University Tuebingen

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02148770     History of Changes
Other Study ID Numbers: 646/2013BO2
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 30, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share the data inside the EU-consortium

Keywords provided by University Hospital Tuebingen:
rt-fmri
self-control
eating behaviour
overweight
neurofeedback