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

NCT04130906 | Withdrawn

• 1 other identifier: Pending
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge-Eating Disorder

Keywords

Binge Eating; Transcranial Magnetic Stimulation; Theta Burst Stimulation; Neuromodulation; Psychiatric Disorders; Eating Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up

• Delay Discounting Task

  Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up

• Emotion Regulation Task

  Baseline, within 1 hour after receiving active or sham stimulation, and 24-hour follow-up

Study Arms (2)

Intermittent Theta Burst Stimulation

ACTIVE COMPARATOR

The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active iTBS.

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.

Device: Sham Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

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.

Also known as: iTBS

Intermittent Theta Burst Stimulation

Sham Intermittent Theta Burst Stimulation DEVICE

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.

Also known as: Sham TBS

Sham Intermittent Theta Burst Stimulation

Eligibility Criteria

• Age: 13 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• South London and Maudsley NHS Foundation Trust: collaborator

Study Sites (1)

King's College London Institute of Psychiatry, Psychology and Neuroscience

London, SE58AF, United Kingdom

Location

MeSH Terms

Conditions

Binge-Eating Disorder; Bulimia; Mental Disorders; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ulrike Schmidt

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: January 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)