Ameliorating Cognitive Control in Binge Eating Disorder

Binge-Eating Disorder Clinical Trial

— ACCElect  

Official title:

Ameliorating Cognitive Control in Binge Eating Disorder by Electrical Brain Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572087
• Other study ID #: GI 878/4-1
• Secondary ID: PL 525/7-1
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: March 9, 2022

Study information

• Verified date: September 2021
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, i.e. 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, i.e. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 9, 2022
• Est. primary completion date: March 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BED according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

• Legal age

• BMI above 20 kg/m2

Exclusion Criteria:

• Insufficient knowledge of German language

• Current pregnancy or lactation period

• Current or lifetime psychotic disorder, bipolar-I disorder, current substance dependence, suicidality

• Past bariatric surgery

• Severe physical disease which influence weight or eating behaviour (e.g. severe diabetes) or neurologic disease

• Non-removable metal parts in the area of the head

• Pacemaker

• Neuroleptics and benzodiazepine

• impaired vision, ametropia, eye diseases

Related Conditions & MeSH terms

• Binge-Eating Disorder
• Bulimia
• Disease
• Feeding and Eating Disorders

Intervention

Other:
• Behavioral training and verum stimulation
Cognitive control training and verum tDCS
• Behavioral training and sham stimulation
Cognitive control training and sham tDCS

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Katrin Giel

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Giel KE, Schag K, Martus P, Max SM, Plewnia C. Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial. J Eat Disord. 2022 Feb 19;10(1):26. doi: 10.1186/s40337-022-00544-7. — View Citation

Max SM, Plewnia C, Zipfel S, Giel KE, Schag K. Combined antisaccade task and transcranial direct current stimulation to increase response inhibition in binge eating disorder. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):17-28. doi: 10.1007/s00406-020-01164-5. Epub 2020 Jul 13. — View Citation

Schag K, Ince B, Zipfel S, Max S, Plewnia C, Giel K. [Non-Invasive Brain Stimulation in the Treatment of Eating Disorders - A Narrative Review]. Psychother Psychosom Med Psychol. 2020 Jun;70(6):246-251. doi: 10.1055/a-1156-8899. Epub 2020 Jun 9. Review. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge eating frequency	Change of the frequency of Binge eating episodes in the last 4 weeks according to the Eating Disorder Examination Interview (EDE) between baseline (T0) and diagnostic post assessment (T8). The EDE is a validated semi-structured clinical interview.	assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	Binge eating frequency follow-up	Change of the frequency of Binge eating episodes in the last 4 weeks according to EDE between baseline (T0) and 3 months follow up (T9)	assessed at baseline (T0) and at 3 months follow-up (T9)
Secondary	antisaccade task	antisaccade task error rate and latency assessed by eye tracking	assessed at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
Secondary	Go/No-Go task	Go/No-Go task task error rate and latency	at baseline (T0) and at the post measurement of task performance within one week after the training (T7)
Secondary	stimulus rating	one self-developed questionnaire including visual analogue scales (0-10 cm) concerning valence, appetite, wanting, liking of the presented stimuli	at baseline (T0) and and the post measurement of task performance within one week after the training (T7)
Secondary	Eating disorder pathology (EDE)	assessed by the Eating Disorder Examination (EDE), Range 0-6 with higer scores indication higer eating disorder pathology	assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9)
Secondary	eating behaviour (TFEQ)	assessed by the Three-factor Eating Questionnaire (TFEQ), Range 0-1 with higher scores indicating more pathological eating behaviour	at baseline (T0), at the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	food craving (FCQ-S)	assessed by the Food Craving Questionnaire, State Version (FCQ-S), Range 1-5 with higher scores indicating higher food craving	at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7)
Secondary	impulsive behaviours per week	assessed by a self-developed process analysis questionnaire, values > 0 (unlimited frequency) with higher scores indicating more impulsive behaviours per week	at baseline (T0), the six training sessions within two weeks (T1-T6), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	impulsivity (UPPS)	assessed by the "UPPS Impulsive Behavior Scale" (UPPS), Range 1-4 with higher scores indicating higher impulsivity	at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	well-being (WHO-5)	assessed by the "WHO (Five) - Well-being Questionnaire" (WHO-5), Range 0-5 with higher scores indicating higher well-being	at baseline (T0), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	depressive symptoms (BDI II)	assessed by the Becks Depression Inventory, Version 2 (BDI II), Range 0-3 with higher scores indicating higher depressive symptoms	at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	Body Mass Index (BMI)	computed by objectively assessed weight and height	at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Secondary	acceptance and feasibility	drop-out rate throughout T0 to T9, percentage of included patients from the eligible patients at T0	from baseline (T0) throughout all measurement points until 3 months follow-up (T9)
Secondary	evaluation of the training programme	self-developed questionnaire at T7 (Range 1-5 with higher cores indicating more satisfaction with the training programme)	assessed at the post measurement of task performance within one week after the training (T7)

External Links

•   research information of the University Tübingen, Germany