Eating DisordersNCT06488287
tDCS and Emotional Eating
A study testing Transcranial direct current stimulation (brain stimulation) in people with Eating Disorders, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Transcranial direct current stimulation (brain stimulation)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
yousef Alhindi contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Nottingham
Derby, Royal Derby Hospital Centre Uttoxeter Road, DE22 3DT
Iskandar Idris, mdzii@exmail.nottingham.ac.uk
yousef Alhindi, alyya2@nottingham.ac.uk
About this study
Official title: The Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Emotional Eating in Tier 3 Obese Patients: A Randomised Controlled Feasibility Trial Protocol
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.
Read the detailed description
Participants were invited to take part in this study based on their registration in the tier 3 bariatric service at the Royal Derby Hospital and a score of more than 6 in the binge eating survey previously completed as part of their clinical care. the invistigators invite 30-40 participants to participate in this study.
After the completion of the consent form participants will be asked to complete a safety questionnaire to check whether there are any known reasons tDCS would not be suitable for them. If it is suitable to participate in a tDCS study for obesity, participants will be randomised to either real tDCS or Sham tDCS (Sham tDCS is like a "fake" version of tDCS. It's used in experiments to make people think they're getting brain stimulation when they're not. This helps researchers see if the real brain stimulation has a genuine effect or if it's just because people believe it will work). The randomization process for group assignment will be conducted using a computer program, which means participants will not have the ability to select or choose their preferred group. participants will receive 6 sessions of real tDCS or sham for three weeks (2 sessions a week). the investigators will follow up with participants for two weeks after the study end. The follow-up procedure will involve the completion of questionnaires and the stop signal task once again. Additionally, body weight measurements will be taken during this stage. Therefore, they will participate for 8 weeks in this study. All sessions will take place in the University of Nottingham medical school at Derby Royal Hospital and University of Nottingham jubilee campus. The first and last session will take approximately 1.30 hours and the other sessions will last 40 minutes each. In the first and last sessions, participants will be asked to fill in 4 questionnaires (30 minutes to fill), doing an impulsivity test (also known as Stop Signal Task) (it is an easy test and will take 5 minutes. The stop signal task is a psychological test that measures participant ability to stop or pause a planned action when they're signalled to do so. It helps assess self-control and how well participants can inhibit or control their impulses) and receive one session of tDCS or sham (20 minutes). In the 4 sessions, the participant will only receive one session of real tDCS or sham. During the study (8 weeks) the participant will be asked to fill a daily food record using mobile app. After the end of the study, the participant will be asked to do an interview to talk about the experience of being in the study. The interview will be conducted at the end of the study either in person or online using Teams.
tDCS has no major safety concerns according to National Institute for health and Care Excellence (NICE 2015). The most frequent temporary side effects are mild tingling, slight itching, moderate fatigue, headache or, less frequently, a slight burning feeling. These effects usually develop at the start of the tDCS and disappear shortly after. Headaches, mild discomfort, or irritation on the skin generally involve slight discomforts that are promptly relieved by over-the-counter pain relief medicines. It is important to inform us of any side effects experienced after the tDCS sessions and to contact participant's GP or treating clinician with any healthcare concerns or study-related questions.
the investigators cannot promise the study will help the participant but the information that investigators get from this study may help to the advancement of scientific knowledge by expanding our understanding of the effects of tDCS on appetite regulation, cognitive control, and long-term behaviour modification in the context of obesity, potentially leading to the development of more effective treatments and interventions for weight management in the future.
the recruitment started on 01/03/2024 and the study end date will be 30/09/2025. this study was funded py the PGR office at the University of Nottingham.
- Conditions
- Eating Disorders
- Being tested
- Transcranial direct current stimulation (brain stimulation), sham Transcranial direct current stimulation (brain stimulation)
- Keywords
- obesity, emotional eating, brain stimulation, tDCS
- Medical subject headings
- Feeding and Eating Disorders, Obesity, Emotional Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Real stimulation | Experimental | Participants in this arm will receive 6 sessions of real tDCS. Receives: Device: Transcranial direct current stimulation (brain stimulation) |
| Sham stimulation | Placebo comparator | Participants in this arm will receive 6 sessions of sham tDCS. Receives: Device: sham Transcranial direct current stimulation (brain stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 weeks
Means and standard deviations of scores on study questionnaires.
- Means and standard deviations of scores on study questionnaires.
Measured: 5 weeks
Dropout ratio in each group
Measured: 5 weeks
Safety of the intervention will be assessed by adverse event reported by patients
Measured: 5 weeks
Secondary outcomes (10)
Body weight (Kg)
Measured: 5 weeks
BMI (kg/m^2)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 weeks
Calories consumption (using food record app)
Measured: 5 weeks
Impulsivity using stop signal task
Measured: 5 weeks
Adverse events
Measured: 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.
Measured: 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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488287
- Sponsor's protocol ID
- 23039
- Status last verified
- Mar 2024
- First submitted
- 7 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Emotional Eating in Tier 3 Obese Patients: A Randomised Controlled Feasibility Trial Protocol
- ClinicalTrials.gov ID
- NCT06488287
- Acronym / sponsor ID
- 23039
- Conditions
- Eating Disorders
- Keywords
- obesity, emotional eating, brain stimulation, tDCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants were invited to take part in this study based on their registration in the tier 3 bariatric service at the Royal Derby Hospital and a score of more than 6 in the binge eating survey previously completed as part of their clinical care. the invistigators invite 30-40 participants to participate in this study.
After the completion of the consent form participants will be asked to complete a safety questionnaire to check whether there are any known reasons tDCS would not be suitable for them. If it is suitable to participate in a tDCS study for obesity, participants will be randomised to either real tDCS or Sham tDCS (Sham tDCS is like a "fake" version of tDCS. It's used in experiments to make people think they're getting brain stimulation when they're not. This helps researchers see if the real brain stimulation has a genuine effect or if it's just because people believe it will work). The randomization process for group assignment will be conducted using a computer program, which means participants will not have the ability to select or choose their preferred group. participants will receive 6 sessions of real tDCS or sham for three weeks (2 sessions a week). the investigators will follow up with participants for two weeks after the study end. The follow-up procedure will involve the completion of questionnaires and the stop signal task once again. Additionally, body weight measurements will be taken during this stage. Therefore, they will participate for 8 weeks in this study. All sessions will take place in the University of Nottingham medical school at Derby Royal Hospital and University of Nottingham jubilee campus. The first and last session will take approximately 1.30 hours and the other sessions will last 40 minutes each. In the first and last sessions, participants will be asked to fill in 4 questionnaires (30 minutes to fill), doing an impulsivity test (also known as Stop Signal Task) (it is an easy test and will take 5 minutes. The stop signal task is a psychological test that measures participant ability to stop or pause a planned action when they're signalled to do so. It helps assess self-control and how well participants can inhibit or control their impulses) and receive one session of tDCS or sham (20 minutes). In the 4 sessions, the participant will only receive one session of real tDCS or sham. During the study (8 weeks) the participant will be asked to fill a daily food record using mobile app. After the end of the study, the participant will be asked to do an interview to talk about the experience of being in the study. The interview will be conducted at the end of the study either in person or online using Teams.
tDCS has no major safety concerns according to National Institute for health and Care Excellence (NICE 2015). The most frequent temporary side effects are mild tingling, slight itching, moderate fatigue, headache or, less frequently, a slight burning feeling. These effects usually develop at the start of the tDCS and disappear shortly after. Headaches, mild discomfort, or irritation on the skin generally involve slight discomforts that are promptly relieved by over-the-counter pain relief medicines. It is important to inform us of any side effects experienced after the tDCS sessions and to contact participant's GP or treating clinician with any healthcare concerns or study-related questions.
the investigators cannot promise the study will help the participant but the information that investigators get from this study may help to the advancement of scientific knowledge by expanding our understanding of the effects of tDCS on appetite regulation, cognitive control, and long-term behaviour modification in the context of obesity, potentially leading to the development of more effective treatments and interventions for weight management in the future.
the recruitment started on 01/03/2024 and the study end date will be 30/09/2025. this study was funded py the PGR office at the University of Nottingham.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real stimulation | Experimental | Device: Transcranial direct current stimulation (brain stimulation)Participants in this arm will receive 6 sessions of real tDCS. |
| Sham stimulation | Placebo comparator | Device: sham Transcranial direct current stimulation (brain stimulation)Participants in this arm will receive 6 sessions of sham tDCS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulation (brain stimulation)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. | Device | Real stimulation |
| sham Transcranial direct current stimulation (brain stimulation)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. | Device | Sham stimulation |
Primary outcome
Response rate and number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study.
Time frame: 5 weeks
Response rate and number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study.
Feasibility of completion study questionnaire.
Time frame: 5 weeks
number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study questionnaire.
Means and standard deviations of scores on study questionnaires.
Time frame: 5 weeks
3. Means and standard deviations of scores on study questionnaires.
Dropout ratio in each group
Time frame: 5 weeks
Safety of the intervention will be assessed by adverse event reported by patients
Time frame: 5 weeks
10 secondary outcomes
Body weight (Kg)
Time frame: 5 weeks
BMI (kg/m^2)
Time frame: 5 weeks
The Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: 5 weeks
The Food Cravings Questionnaire-State (FCQ-S)
Time frame: 5 weeks
The Emotional Eating Scale II (EES-II)
Time frame: 5 weeks
Calories consumption (using food record app)
Time frame: 5 weeks
Impulsivity using stop signal task
Time frame: 5 weeks
Adverse events
Time frame: 5 weeks
The Food Craving Questionnaire-Trait (FCQ-T)
Time frame: 5 weeks
The Food Craving Inventory (FCI)
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yousef Alhindi contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (brain stimulation) in people with Eating Disorders, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iskandar Idris (01332 724710/724713, mdzii@exmail.nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate and number of patients who met the inclusion criteria, agreed to participate in the study, and completed the study. (time frame: 5 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.