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Theta Burst Stimulation in Binge Eating Disorder: A Single Session RCT (BITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04130906
Recruitment Status : Suspended (The study includes adults vulnerable to COVID-19 and procedures cannot accommodate social distancing.)
First Posted : October 18, 2019
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Device: Intermittent Theta Burst Stimulation Device: Sham Intermittent Theta Burst Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Feasibility Trial of Theta Burst Stimulation in Binge Eating Disorder
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Arm Intervention/treatment
Active Comparator: Intermittent Theta Burst Stimulation
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active iTBS.
Device: Intermittent Theta Burst Stimulation
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.
Other Name: iTBS

Sham Comparator: Sham Intermittent Theta Burst Stimulation
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
Device: Sham Intermittent Theta Burst Stimulation
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.
Other Name: Sham TBS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Visual Analogue Scale Measure of General Psychopathology [ Time Frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up ]
    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.

  2. Delay Discounting Task [ Time Frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up ]
    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).

  3. Emotion Regulation Task [ Time Frame: Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130906


Locations
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United Kingdom
King's College London Institute of Psychiatry, Psychology and Neuroscience
London, United Kingdom, SE58AF
Sponsors and Collaborators
King's College London
South London and Maudsley NHS Foundation Trust
Investigators
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Principal Investigator: Ulrike Schmidt King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04130906    
Other Study ID Numbers: Pending
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Binge Eating
Transcranial Magnetic Stimulation
Theta Burst Stimulation
Neuromodulation
Psychiatric Disorders
Eating Disorders
Additional relevant MeSH terms:
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Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive