tDCS and Emotional Eating
NCT Number: NCT06488287
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Eating Disorders
Interventions: DEVICE: Transcranial direct current stimulation (brain stimulation)|DEVICE: sham Transcranial direct current stimulation (brain stimulation)
Sponsor: University of Nottingham
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-02-01
Completion Date: 2025-09-30
Locations: University of Nottingham, Derby, Royal Derby Hospital Centre Uttoxeter Road, DE22 3DT, United Kingdom

Summary:
This research investigates the feasibility of undertaking a large, randomised control trial of transcranial direct current stimulation (tDCS) as a treatment modality for managing food cravings and emotional eating. This study explores how tDCS, a non-invasive brain stimulation technique, can influence brain activity and potentially impact appetite regulation, self-control, reward processing, and other factors related to weight management.

All participants will receive 6 sessions of stimulation within three weeks. the investigators aim to implement a two-day interval between intervention sessions, providing participants with a two-day rest period between sessions. This scheduling approach is intended to mitigate potential side effects and promote participants' recovery.

Primary Outcome Measures: Response rate and number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study., Response rate and number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study., 5 weeks|Feasibility of completion study questionnaire., number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study questionnaire., 5 weeks|Means and standard deviations of scores on study questionnaires., 3. Means and standard deviations of scores on study questionnaires., 5 weeks|Dropout ratio in each group, 5 weeks|Safety of the intervention will be assessed by adverse event reported by patients, 5 weeks
Secondary Outcome Measures: Body weight (Kg), 5 weeks|BMI (kg/m^2), 5 weeks|The Eating Disorder Examination Questionnaire (EDE-Q), The Eating Disorder Examination Questionnaire (EDE-Q) is a widely used self-report measure for assessing the range and severity of eating disorder symptoms. It consists of 28 items and evaluates behaviours and attitudes associated with eating disorders over the past 28 days.

The questionnaire is divided into four subscales: A global score of 2.3 is often used as a cut-off to identify probable eating disorders., 5 weeks|The Food Cravings Questionnaire-State (FCQ-S), The Food Cravings Questionnaire-State (FCQ-S) measures momentary food cravings using a 15-item scale. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). This gives the FCQ-S a minimum possible score of 15 and a maximum possible score of 75. High score means worse symptoms., 5 weeks|The Emotional Eating Scale II (EES-II), The Emotional Eating Scale II (EES-II) is an extended version of the original Emotional Eating Scale (EES), designed to assess eating in response to both positive and negative emotions. The EES-II consists of 33 items, each rated on a 5-point scale from 0 (no desire to eat) to 4 (an overwhelming urge to eat). This results in a minimum score of 0 and a maximum score of 132.

The EES-II includes subscales that measure eating in response to different emotional states:

Anger/Frustration (9 items) Anxiety (8 items) Depression (10 items) Positive Emotions (6 items) Higher scores on the EES-II indicate a greater tendency to eat in response to emotional states, both positive and negative., 5 weeks|Calories consumption (using food record app), 5 weeks|Impulsivity using stop signal task, 5 weeks|Adverse events, 5 weeks|The Food Craving Questionnaire-Trait (FCQ-T), The Food Craving Questionnaire-Trait (FCQ-T) assesses the frequency and intensity of food cravings over time and consists of 39 items. Each item is rated on a 6-point Likert scale, where 1 indicates "never" and 6 indicates "always." The total score ranges from a minimum of 39 to a maximum of 234. Higher scores reflect greater food craving tendencies., 5 weeks|The Food Craving Inventory (FCI), The Food Craving Inventory (FCI) is a self-report measure designed to assess the frequency of food cravings for specific food types over the past month. The FCI consists of 28 items, each rated on a 5-point scale from 1 (never) to 5 (always/almost every day). This gives the FCI a minimum possible score of 28 and a maximum possible score of 140. high score means worse symptoms., 5 weeks