CNS Modification of Food Craving by Neurofeedback
1 other identifier
interventional
5
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2015
Shorter than P25 for not_applicable obesity
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 24, 2015
June 1, 2015
4 months
May 28, 2015
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase brain activity in frontal brain areas
7 weeks
Secondary Outcomes (4)
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
7 weeks
Behavioural measures
12 months
Anthropometric measures
12 months
Number of participants with adverse events
12 months
Study Arms (1)
single arm pilot feasibility study
EXPERIMENTALHematoencephalography bio/neurofeedback for Brain neural activity modulation. H.E.G. (hematoencephalography) based neurofeedback program. No drug use.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Right handed BMI in the range of 28-35kg/m2
You may not qualify if:
- Current or past history of any major psychiatric disorder
- Major medical or neurological disorders
- Exposure to drugs likely to influence cerebral blood flow or neurological function within 3 weeks
- History of drug or alcohol abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Percik R, Cina J, Even B, Gitler A, Geva D, Seluk L, Livny A. A pilot study of a novel therapeutic approach to obesity: CNS modification by N.I.R. H.E.G. neurofeedback. Clin Nutr. 2019 Feb;38(1):258-263. doi: 10.1016/j.clnu.2018.01.023. Epub 2018 Feb 15.
PMID: 29428788DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Percik, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 28, 2015
First Posted
June 24, 2015
Study Start
June 1, 2015
Primary Completion
October 1, 2015
Study Completion
April 1, 2016
Last Updated
June 24, 2015
Record last verified: 2015-06