tDCS and Emotional Eating

NCT06488287 | Recruiting

• 1 other identifier: 23039
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Eating Disorders

Keywords

obesity; emotional eating; brain stimulation; tDCS

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (10)

• Body weight (Kg)

  5 weeks

• BMI (kg/m^2)

  5 weeks

• The Eating Disorder Examination Questionnaire (EDE-Q)

  5 weeks

• The Food Cravings Questionnaire-State (FCQ-S)

  5 weeks

• The Emotional Eating Scale II (EES-II)

  5 weeks

Study Arms (2)

Real stimulation

EXPERIMENTAL

Participants in this arm will receive 6 sessions of real tDCS.

Device: Transcranial direct current stimulation (brain stimulation)

Sham stimulation

PLACEBO COMPARATOR

Participants in this arm will receive 6 sessions of sham tDCS.

Device: sham Transcranial direct current stimulation (brain stimulation)

Interventions

Transcranial direct current stimulation (brain stimulation) DEVICE

The intervention will be applied using two sponge electrodes soaked in a saline solution. The stimulation montage will comprise left DLPFC anodal or sham stimulation. The reference (cathodal) electrode will be placed over the right supraorbital ridge, and the anodal electrode will be placed over the region corresponding to the left DLPFC (F3 of the EEG10-20 international system). The 2mA continuous current will be applied during the active stimulation condition via gradual ramps that start and stop after 30 seconds of stimulation (current ramps). For sham stimulation, the electrodes will remain in place for the whole session, but the current will only be applied for the first 36 seconds of the stimulation. Each tDCS session will last for 20 minutes.

Real stimulation

sham Transcranial direct current stimulation (brain stimulation) DEVICE

The intervention will be applied using two sponge electrodes soaked in a saline solution. The stimulation montage will comprise left DLPFC anodal or sham stimulation. The reference (cathodal) electrode will be placed over the right supraorbital ridge, and the anodal electrode will be placed over the region corresponding to the left DLPFC (F3 of the EEG10-20 international system). For sham stimulation, the electrodes will remain in place for the whole session, but the current will only be applied for the first 36 seconds of the stimulation. Each tDCS session will last for 20 minutes.

Sham stimulation

Eligibility Criteria

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

You may qualify if:

• Patients with obesity in tier 3.
• Capacity to consent to participate in research.
• Adults aged 18 to 65 years old.
• A high score in the emotional eating survey (minimum of 6 score in weight loss readiness questionnaire) (this will be taken from participant's medical note by usual care staff)

You may not qualify if:

• Non-obese patients (BMI\<25).
• A history of epilepsy or other major neurological disorders
• Having pacemakers or other metal implants.
• No history of eating disorders or emotional eating.
• Pregnant patients.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

University of Nottingham

Derby, Royal Derby Hospital Centre Uttoxeter Road, DE22 3DT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Obesity; Emotional Eating

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Iskandar Idris

CONTACT

01332 724710/724713; mdzii@exmail.nottingham.ac.uk

yousef Alhindi

CONTACT

alyya2@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: July 5, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: September 30, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)