Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04572087
Status:
COMPLETED
Last Update Posted:
2022-05-27
First Post:
2020-09-16
Brief Title:
Ameliorating Cognitive Control in Binge Eating Disorder
Sponsor:
Prof Dr Katrin Giel
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Ameliorating Cognitive Control in Binge Eating Disorder by Electrical Brain Stimulation
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCElect
Brief Summary:
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders especially in Binge Eating Disorder BED BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating Controlling impulsive behaviour cognitive flexibility planning and decision making are key abilities of impulse regulation Some of these impaired cognitive functions are linked to decreased activity of certain brain regions Transcranial direct current stimulation tDCS is a well-established method to alter brain activity In the current project we explore if a computer-assisted training programme for patients with BED that is combined with tDCS is feasible and able to ameliorate impulse regulation and impulsive eating behaviour We hypothesize that the cognitive training programme with additional tDCS will result in a greater decrease of BED symptoms and a stronger increase in impulse regulation skills compared with the cognitive training programme without tDCS by using a placebo stimulation
Detailed Description:
Patients with BED form a subgroup of obese patients with a disinhibited eating pattern that is associated with major impairments in cognitive control The dorsolateral prefrontal cortex dlPFC has been identified as a brain region closely tied to cognitive control processes and crucially involved in the control of eating behaviour This suggests the dlPFC as a target for the modulation of cognitive control processes over eating in BED This modulation can be achieved by both a cognitive training task and by noninvasive brain stimulation using tDCS In studies with healthy normal-weight participants 1 different cognitive training task enhance control over eating behaviour 2 tDCS is an effective tool to ameliorate cognitive control processes and 3 has beneficial effects on motivational aspects of eating behaviour ie food craving Based on this evidence we will use a combination of a cognitive control task and tDCS to enhance cognitive control over eating in patients with BED This is to the best of our knowledge one of the first studies to use tDCS as an intervention to enhance cognitive control over eating in patients with BED
o Sample size We will allocate 40 patients in the trial ie 20 patients in each study arm
o Recruitment Patients are recruited by announcements mails to the distributor list of the university hospital existing databases of patients and current patients of the university hospital Patients are screened by a standardized checklist In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation
o Standard Operating Procedures For the recruitment diagnostic and experimental sessions Standard Operating Procedures are documented for the experimenter This includes the order of clinical interviews questionnaires and operating with the technical measurement instruments The experimenters are regularly supervised All adverse events will be listed and severe adverse events will be reported immediately to the PIs
o Quality assurance plan Randomized allocation to the stimulation condition verum vs sahm and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry University Tübingen Germany ICEAB Objective technical measurement instruments are mostly used to record data
o Data checks Data is recorded mostly by objective technical measurement instruments so no external monitoring is needed We will spot check entered questionnaire data in particular binge eating frequency in the past four weeks will be double checked as this is the primary outcome PO
o Source data verification Data are spot checked by comparing the entries in the source data with the entries in the database Each PO entry will be double checked There are pre-defined criteria for entering data into the database
Data dictionary
A data dictionary that contains detailed descriptions of each variable and how to be entered is available
o Plan for missing data Missing data and invalid data as well as the reasons will be recorded
o Statistical analysis plan A mixed model approach will be used to analyze the PO and secondary outcomes SOs
o Sample size We will allocate 40 patients in the trial ie 20 patients in each study arm
o Recruitment Patients are recruited by announcements mails to the distributor list of the university hospital existing databases of patients and current patients of the university hospital Patients are screened by a standardized checklist In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation
o Standard Operating Procedures For the recruitment diagnostic and experimental sessions Standard Operating Procedures are documented for the experimenter This includes the order of clinical interviews questionnaires and operating with the technical measurement instruments The experimenters are regularly supervised All adverse events will be listed and severe adverse events will be reported immediately to the PIs
o Quality assurance plan Randomized allocation to the stimulation condition verum vs sahm and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry University Tübingen Germany ICEAB Objective technical measurement instruments are mostly used to record data
o Data checks Data is recorded mostly by objective technical measurement instruments so no external monitoring is needed We will spot check entered questionnaire data in particular binge eating frequency in the past four weeks will be double checked as this is the primary outcome PO
o Source data verification Data are spot checked by comparing the entries in the source data with the entries in the database Each PO entry will be double checked There are pre-defined criteria for entering data into the database
Data dictionary
A data dictionary that contains detailed descriptions of each variable and how to be entered is available
o Plan for missing data Missing data and invalid data as well as the reasons will be recorded
o Statistical analysis plan A mixed model approach will be used to analyze the PO and secondary outcomes SOs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PL 5257-1 | OTHER_GRANT | Deutsche Forschungsgemeinschaft | None |