Binge-Eating DisorderBITENCT04130906
Theta Burst Stimulation in Binge Eating Disorder: A Single Session RCT
A study testing Intermittent Theta Burst Stimulation in people with Binge-Eating Disorder, run by King's College London at 1 site in United Kingdom.
Trial summary
Binge eating disorder (BED) is a common and disabling eating disorder (ED) which presents a substantial disease burden. Individuals seeking treatment for binge eating difficulties typically receive talking therapy treatment however, treatment response is inadequate. Read more about this study
- Who is it for?
- Ages 13 to 60 years
- Conditions the study is for
- Binge-Eating Disorder
- What is being tested?
- Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2021to 1 May 2021
- 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 13 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Right handed
- Meets DSM-5 criteria for full-syndrome BED
- Overweight or obese according to World Health Organisation (WHO) criteria (BMI>25 kg/m2 for adults, and a weight-for-height greater than 2 standard deviations above the median for adolescents).
Who cannot join
- All known contraindications to MRI and TBS (assessed using TMS and MRI safety screening questionnaires)
- Pregnancy (or suspected pregnancy)
- History of neurological disease and/or seizure
- Having any metallic implants anywhere in the head or body
- History of head or eye injury; significant health problems in the previous six months;
- Lifetime diagnosis of substance dependence, psychosis, bipolar disorder, borderline personality disorder
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- Other primary psychiatric disorder requiring treatment in its own right
- Taking psychotropic medication other than a stable dosage of selective serotonin reuptake inhibitors (SSRI) for at least 14 days prior to study enrollment
- Alcohol consumption exceeding 14 units per week
- Cigarette consumption or nicotine replacement exceeding >15 cigarettes daily or equivalent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London Institute of Psychiatry, Psychology and Neuroscience
London, SE58AF
About this study
Official title: A Feasibility Trial of Theta Burst Stimulation in Binge Eating Disorder
Binge eating disorder (BED) is a common and disabling eating disorder (ED) which presents a substantial disease burden. Individuals seeking treatment for binge eating difficulties typically receive talking therapy treatment however, treatment response is inadequate. As such, it is imperative that novel treatment options be identified.
Repetitive transcranial magnetic stimulation (rTMS) techniques are well established for the treatment of depression and preliminary findings indicate that similarly therapeutic effects may occur in populations with eating difficulties. Intermittent theta burst stimulation (iTBS) is a novel variant of excitatory rTMS which is emerging as an attractive alternative to standard stimulation. This trial aims to assess the feasibility of conducting a large scale randomised controlled trial (RCT) investigating theta burst in individuals with binge eating disorder, and to examine whether theta burst stimulation may improve symptoms in this population.
Read the detailed description
Binge eating is a common and disabling problem which is often associated with obesity. Binge eating causes significant distress and compromises quality of life in affected individuals. To date current treatments do not support full recovery in a considerable number of adults and adolescents. As such, it is important that we explore new options for treatment.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure that is emerging as a potentially effective treatment for a range of psychiatric disorders. In rTMS, an electric current is passed through a coil placed on the scalp. This current creates a magnetic field which changes the activity in the brain area immediately below the coil. rTMS is a well-established treatment for depression and has been approved by the National Institute for Care and Excellence (NICE; 2015). The NICE-approved rTMS treatment for depression involves 20-30 sessions, each requiring 37.5 minutes of stimulation. A novel variant of rTMS, intermittent theta burst stimulation (iTBS), is an attractive alternative to standard stimulation; TBS, which is delivered using a very similar procedure as standard rTMS, may produce effects comparable to standard rTMS in as little as 3 minutes.
In depression, the therapeutic applications for rTMS have been widely studied. By comparison, research examining the potential applications of rTMS for the treatment of eating disorders and obesity are preliminary. Nevertheless, studies in eating disorders and obesity to date have reported promising results. For example, a case study involving a patient with refractory BED and comorbid depression reported clinical improvement following 20 sessions of high frequency (excitatory) rTMS targeting the left DLPFC (Baczynski et al, 2014). Similarly, two recent studies of obese adults have reported a reduction in food intake, reduced craving, and significant weight loss following 20 sessions of high frequency rTMS targeting the left DLPFC (Alvarado-Reynoso \& Ambriz-Tututi, 2019; Kim et al, 2018). Finally, studies in healthy participants reporting strong cravings and clinical participants with bulimia nervosa have also reported a reduction in craving and food-intake following high frequency rTMS (for example, Dunlop et al, 2015; Van den Eynde, 2010, and Uher et al, 2010). No study to date has used iTBS in eating disorders.
The primary objective for this trial is to assess whether iTBS may benefit people with binge eating difficulties. As such, we are conducting two inter-related studies: (1) a proof-of-concept randomised double-blind sham-controlled trial involving a single-session of either real or sham iTBS, and (2) a therapeutic case series involving 20 sessions of real iTBS delivered week-daily over four consecutive weeks.
- Conditions
- Binge-Eating Disorder
- Being tested
- Intermittent Theta Burst Stimulation, Sham Intermittent Theta Burst Stimulation
- Keywords
- Binge Eating, Transcranial Magnetic Stimulation, Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Eating Disorders
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Mental Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
Also called iTBS
iTBS will be delivered to the left dorsolateral prefrontal cortex (DLPFC) at 80% of resting motor threshold using standard stimulation parameters; triplet-bursts will be delivered at high frequency (50 Hz) with an inter-burst interval of 200 ms. Each TBS train will last 2 seconds and consists of 10 triplet-bursts (30 pulses). Each iTBS session will involve 10 TBS trains repeated every 10 seconds for 190 seconds, with a total number of 600 pulses delivered during each session.
Sham Intermittent Theta Burst StimulationDevice
Also called Sham TBS
Sham stimulation will be delivered left dorsolateral prefrontal cortex (DLPFC) using the same parameters as real iTBS however, a sham coil will be used. The sham coil makes the same noise and creates a similar sensation on the scalp as the real coil but does not produce a magnetic field.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Theta Burst Stimulation | Active comparator | The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active iTBS. Receives: Device: Intermittent Theta Burst Stimulation |
| Sham Intermittent Theta Burst Stimulation | Sham comparator | The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil. Receives: Device: Sham Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Disorder Visual Analogue Scale Measure of Symptom Severity
An index of BED symptoms will be computed by summing the scores on four 10cm visual analogue scales (VAS) assessing levels of current hunger, craving for food, urge to eat and urge to binge eat. Participants will indicate along the line the extent to which they are experiencing the symptom described, with a mark at 0cm indicating "None" and 10cm indicating "Extreme". Higher scores indicate higher BED severity.
Measured: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Secondary outcomes (3)
Visual Analogue Scale Measure of General Psychopathology
An index of "related psychopathology" will be computed by summing the scores on four 10cm visual analogue scales (VAS) assessing feeling low, level of tension, level of stress and level of anxiety will then be completed. Participants will indicate along the line the extent to which they are experiencing the symptom described, with a mark at 0cm indicating "None" and 10cm indicating "Extreme". Higher scores indicate greater symptom severity.
Measured: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Delay Discounting Task
Participants complete a series of 27 questions that each require choosing between a smaller, immediate reward (e.g., £25 today) versus a larger, later reward (e.g., £35 in 25 days). Modeling techniques are used to fit the function that relates time to discounting. The main dependent measure of interest is the change in the steepness of the discounting curve from baseline to post-iTBS; A more steeply declining curve represents a tendency to devalue rewards as they become more temporally remote (i.e., further way).
Measured: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Emotion Regulation Task
Participants will view images from the international affective picture schedule and be asked to either experience their emotions naturally or to use a reappraisal strategy to increase or decrease their emotional experience. Heart rate data will be collected during task completion. The main dependent measure of interest is change in high frequency heart rate variability for each condition (watch or reappraise) from baseline to post TBS.
Measured: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Jan 2021 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2021 (estimated)
Why it stopped: COVID led to suspension of the study.New data suggest outcome measures should be revised and new approvals from research ethics committees will be needed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Ulrike Schmidt, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130906
- Sponsor's protocol ID
- Pending
- Acronym
- BITE
- Status last verified
- Mar 2022
- First submitted
- 16 Oct 2019
- Last updated
- 7 Apr 2022
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Theta Burst Stimulation in Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04130906
- Acronym / sponsor ID
- BITE / Pending
- Conditions
- Binge-Eating Disorder
- Keywords
- Binge Eating, Transcranial Magnetic Stimulation, Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Eating Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID led to suspension of the study.New data suggest outcome measures should be revised and new approvals from research ethics committees will be needed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
Binge eating disorder (BED) is a common and disabling eating disorder (ED) which presents a substantial disease burden. Individuals seeking treatment for binge eating difficulties typically receive talking therapy treatment however, treatment response is inadequate. As such, it is imperative that novel treatment options be identified.
Repetitive transcranial magnetic stimulation (rTMS) techniques are well established for the treatment of depression and preliminary findings indicate that similarly therapeutic effects may occur in populations with eating difficulties. Intermittent theta burst stimulation (iTBS) is a novel variant of excitatory rTMS which is emerging as an attractive alternative to standard stimulation. This trial aims to assess the feasibility of conducting a large scale randomised controlled trial (RCT) investigating theta burst in individuals with binge eating disorder, and to examine whether theta burst stimulation may improve symptoms in this population.
Detailed description
Binge eating is a common and disabling problem which is often associated with obesity. Binge eating causes significant distress and compromises quality of life in affected individuals. To date current treatments do not support full recovery in a considerable number of adults and adolescents. As such, it is important that we explore new options for treatment.
Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive procedure that is emerging as a potentially effective treatment for a range of psychiatric disorders. In rTMS, an electric current is passed through a coil placed on the scalp. This current creates a magnetic field which changes the activity in the brain area immediately below the coil. rTMS is a well-established treatment for depression and has been approved by the National Institute for Care and Excellence (NICE; 2015). The NICE-approved rTMS treatment for depression involves 20-30 sessions, each requiring 37.5 minutes of stimulation. A novel variant of rTMS, intermittent theta burst stimulation (iTBS), is an attractive alternative to standard stimulation; TBS, which is delivered using a very similar procedure as standard rTMS, may produce effects comparable to standard rTMS in as little as 3 minutes.
In depression, the therapeutic applications for rTMS have been widely studied. By comparison, research examining the potential applications of rTMS for the treatment of eating disorders and obesity are preliminary. Nevertheless, studies in eating disorders and obesity to date have reported promising results. For example, a case study involving a patient with refractory BED and comorbid depression reported clinical improvement following 20 sessions of high frequency (excitatory) rTMS targeting the left DLPFC (Baczynski et al, 2014). Similarly, two recent studies of obese adults have reported a reduction in food intake, reduced craving, and significant weight loss following 20 sessions of high frequency rTMS targeting the left DLPFC (Alvarado-Reynoso \& Ambriz-Tututi, 2019; Kim et al, 2018). Finally, studies in healthy participants reporting strong cravings and clinical participants with bulimia nervosa have also reported a reduction in craving and food-intake following high frequency rTMS (for example, Dunlop et al, 2015; Van den Eynde, 2010, and Uher et al, 2010). No study to date has used iTBS in eating disorders.
The primary objective for this trial is to assess whether iTBS may benefit people with binge eating difficulties. As such, we are conducting two inter-related studies: (1) a proof-of-concept randomised double-blind sham-controlled trial involving a single-session of either real or sham iTBS, and (2) a therapeutic case series involving 20 sessions of real iTBS delivered week-daily over four consecutive weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent Theta Burst Stimulation | Active comparator | Device: Intermittent Theta Burst StimulationThe Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active iTBS. |
| Sham Intermittent Theta Burst Stimulation | Sham comparator | Device: Sham Intermittent Theta Burst StimulationThe Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil. |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Right handed
- Meets DSM-5 criteria for full-syndrome BED
- Overweight or obese according to World Health Organisation (WHO) criteria (BMI>25 kg/m2 for adults, and a weight-for-height greater than 2 standard deviations above the median for adolescents).
Key exclusion criteria (10 listed)
- All known contraindications to MRI and TBS (assessed using TMS and MRI safety screening questionnaires)
- Pregnancy (or suspected pregnancy)
- History of neurological disease and/or seizure
- Having any metallic implants anywhere in the head or body
- History of head or eye injury; significant health problems in the previous six months;
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 |
|---|---|---|
| Intermittent Theta Burst StimulationAlso: iTBSiTBS will be delivered to the left dorsolateral prefrontal cortex (DLPFC) at 80% of resting motor threshold using standard stimulation parameters; triplet-bursts will be delivered at high frequency (50 Hz) with an inter-burst interval of 200 ms. Each TBS train will last 2 seconds and consists of 10 triplet-bursts (30 pulses). Each iTBS session will involve 10 TBS trains repeated every 10 seconds for 190 seconds, with a total number of 600 pulses delivered during each session. | Device | Intermittent Theta Burst Stimulation |
| Sham Intermittent Theta Burst StimulationAlso: Sham TBSSham stimulation will be delivered left dorsolateral prefrontal cortex (DLPFC) using the same parameters as real iTBS however, a sham coil will be used. The sham coil makes the same noise and creates a similar sensation on the scalp as the real coil but does not produce a magnetic field. | Device | Sham Intermittent Theta Burst Stimulation |
Primary outcome
Binge Eating Disorder Visual Analogue Scale Measure of Symptom Severity
Time frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
An index of BED symptoms will be computed by summing the scores on four 10cm visual analogue scales (VAS) assessing levels of current hunger, craving for food, urge to eat and urge to binge eat. Participants will indicate along the line the extent to which they are experiencing the symptom described, with a mark at 0cm indicating "None" and 10cm indicating "Extreme". Higher scores indicate higher BED severity.
3 secondary outcomes
Visual Analogue Scale Measure of General Psychopathology
Time frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Delay Discounting Task
Time frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Emotion Regulation Task
Time frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- 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.
Ulrike Schmidt principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation in people with Binge-Eating Disorder, run by King's College London 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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 7 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binge Eating Disorder Visual Analogue Scale Measure of Symptom Severity (time frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up). 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 7 Apr 2022.