Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488287
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-07
Brief Title:
tDCS and Emotional Eating
Sponsor:
University of Nottingham
Organization:
University of Nottingham
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Its used in experiments to make people think theyre getting brain stimulation when theyre not This helps researchers see if the real brain stimulation has a genuine effect or if its 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 130 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 theyre 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 participants 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 01032024 and the study end date will be 30092025 this study was funded py the PGR office at the University of Nottingham
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 Its used in experiments to make people think theyre getting brain stimulation when theyre not This helps researchers see if the real brain stimulation has a genuine effect or if its 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 130 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 theyre 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 participants 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 01032024 and the study end date will be 30092025 this study was funded py the PGR office at the University of Nottingham
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None