Ameliorating Cognitive Control in Binge Eating Disorder

NCT04572087 | Completed

• 2 other identifiers: GI 878/4-1PL 525/7-1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Keywords

Brain stimulation; cognitive control; behavioral training; binge eating disorder; response inhibition; eye tracking; eating disorder; impulsivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Binge eating frequency follow-up

  assessed at baseline (T0) and at 3 months follow-up (T9)

• antisaccade task

  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)

• Go/No-Go task

  at baseline (T0) and at the post measurement of task performance within one week after the training (T7)

• stimulus rating

  at baseline (T0) and and the post measurement of task performance within one week after the training (T7)

• Eating disorder pathology (EDE)

  assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9)

Study Arms (2)

Cognitive Control Training + Verum stimulation

EXPERIMENTAL

This arm consists of the cognitive control training (six sessions) combined with 2mA anodal tDCS over the right dlPFC (F4) during the training for 20 minutes.

Other: Behavioral training and verum stimulation

Cognitive Control Training + Sham stimulation

ACTIVE COMPARATOR

This arm consists of cognitive control training (six sessions) with sham-tDCS. 2 mA Sham-tDCS (40 seconds of tDCS) is applied to the right dlPFC (F4) before the trainings starts.

Other: Behavioral training and sham stimulation

Interventions

Behavioral training and verum stimulation OTHER

Cognitive control training and verum tDCS

Cognitive Control Training + Verum stimulation

Behavioral training and sham stimulation OTHER

Cognitive control training and sham tDCS

Cognitive Control Training + Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BED according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Legal age
• BMI above 20 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Katrin Giel: lead

Study Sites (1)

University Hospital Tübingen

Tübingen, 72076, Germany

Location

Related Publications (3)

• 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.

  PMID: 32661703 BACKGROUND

• 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. German.

  PMID: 32516813 BACKGROUND

• 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.

  PMID: 35183261 BACKGROUND

Related Links

• research information of the University Tübingen, Germany

MeSH Terms

Conditions

Binge-Eating Disorder; Feeding and Eating Disorders; Impulsive Behavior

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Katrin E Giel, Prof. Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Christian Plewnia, Prof. Dr.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants as well as the experimenters are blinded to the treatment group by using a unique 5-digit code for each participant which activates either verum or sham stimulation. The participants and experimenters are blinded to the randomisation condition as current in the sham condition is applied for 40 seconds at the beginning of each training session and during this time, no training of the cognitive control task is done. As participants perceive typical sensations of tDCS (e.g. tingling) and tDCS electrodes are actually mounted, this is considered as a valid placebo control. The PIs and the biostatistician from the external ICEAB who is doing the statistical analysis are blinded as well until the end of the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: After the baseline measure (T0) without tDCS, participants are randomized to either the group that receives 6 training sessions (T1-T6) with 2 milliampere (ma) anodal tDCS to the right dlPFC or the group that receives 6 training sessions and sham tDCS. After the six training sessions within 2 weeks a post measurement concerning task performance (T7) without tDCS takes place. 4 Weeks after treatment, the diagnostic post measurement (T8) will be executed. 3 months later, a follow-up via phone (T9) will be done.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 1, 2020
• Study Start: September 8, 2020
• Primary Completion: March 9, 2022
• Study Completion: March 9, 2022
• Last Updated: May 27, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)