CNS Modification of Food Craving by Neurofeedback
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|ClinicalTrials.gov Identifier: NCT02480179|
Recruitment Status : Unknown
Verified June 2015 by Dr. Ruth Perchik, Sheba Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
The investigators plan to evaluate H.E.G. (Hematoencephalography) modality in brain modulation of appetite and food craving in a randomized controlled study. The H.E.G. will serve as the neurofeedback modality while the functional brain imaging will enable assessment and hopefully validation of changes brain activity related to food craving and self-control. H.E.G. is a relatively new neurofeedback technique which similar to fMRI, is based on changes in blood oxygenation level as a result of regional brain activation. The unique advantage of this technology regarding our enterprise is that it inheritably samples the two brain areas that are in our focus of interest: the superior orbito-frontal cortex (OFC) which Involved in self-control and reward processing, and the anterior cingulate cortex (ACC) which processes cognitive and emotional information. The investigators will combine HRV (Heart rate variability) biofeedback, which is a well-established treatment form in the investigators therapeutic sessions and will correlate functional neuroimaging with behavioral, anthropometric and laboratory data.
The intervention name is: Measurements of blood flow changes within the brain and online visual feedback to the participant by a H.E.R. (Hematoencephalography) N.I,R (Near Infra Red sensor) sensor made by MindMedia, The Netherlands and a NEXUX4 Hardware, Bluetooth unit, Bio Trace Plus software made by MindMedia, The Netherlands.
Hypothesis: The neurofeedback practice sessions are expected to facilitate improved control of blood flow to frontal brain areas, as a marker of brain activity in these areas
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Device: H.E.G. (hematoencephalography) based neurofeedback||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CNS Modification of Food Craving by Neurofeedback|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||April 2016|
Experimental: single arm pilot feasibility study
Hematoencephalography bio/neurofeedback for Brain neural activity modulation. H.E.G. (hematoencephalography) based neurofeedback program. No drug use.
Device: H.E.G. (hematoencephalography) based neurofeedback
H.E.G. is a relatively new neurofeedback technique which, similar to fMRI is based on differential oxygenated blood supply according to regional brain activity.
Other Name: ProComp2 - 2 Channel Biofeedback & Neurofeedback System w/ BioGraph Infiniti Software - T7400M
- Increase brain activity in frontal brain areas [ Time Frame: 7 weeks ]
- Increased activation of superior frontal brain regions and middle temporal regions in response to food stimuli, in the second fMRI session, perforemed after the neurofeedback sessions, compared to baseline session [ Time Frame: 7 weeks ]Activation of superior frontal brain regions and middle temporal regions in response to food stimuli, known to correlate with inhibition, self control and executive functions.
- Behavioural measures [ Time Frame: 12 months ]Increased scores of self control and inhibition and decreased scores of binge eating and emotional eating on questionnaires.
- Anthropometric measures [ Time Frame: 12 months ]weight loss according to follow-up 6 and 12 months after intervention.
- Number of participants with adverse events [ Time Frame: 12 months ]
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): NCT02480179
|Contact: Ruth Percik, MDfirstname.lastname@example.org|
|Contact: Jenny Cina, Ph.Demail@example.com|
|Principal Investigator:||Ruth Percik, MD||Sheba Medical Center|