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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Miss Amelia Hemmings
+44 2078485977
amelia.1.hemmings@kcl.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Intermittent theta burst stimulation for young people with persistent anorexia nervosa
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Intermittent theta burst stimulation for young people with persistent anorexia nervosa

Recruiting

Open to: All Genders

Age: Mixed

London

Medical Conditions

Anorexia nervosa

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Anorexia Nervosa (AN) is a serious disorder with often devastating consequences. For people with AN who do not respond to first-line psychological therapies, and/or have a longer illness duration, there are currently no specific superior treatments associated with positive longer-term outcomes. Research suggests that self-regulatory ability is weakened in a range of neuropsychiatric disorders, including AN. This could be a consequence of developmental dysfunction in frontostriatal circuits (neural pathways in brain). High-frequency repetitive transcranial stimulation (rTMS) can improve self-regulatory control and also symptoms in disorders that have a frontostriatal dysfunction. The first multi-session RCT of rTMS for people with AN demonstrated short and longer-term efficacy. This study employs a non-inferior protocol (Intermittent theta burst stimulation, iTBS) with a shorter stimulation period compared to classical high-frequency rTMS.

The aim of this study is to assess the feasibility of iTBS as an adjunct to treatment for young people with AN, by collecting data on recruitment, retention, acceptability, and tolerability, with retention of participants our primary outcome. We will also explore changes in AN and related clinical symptoms, BMI, quality of life, neurocognitive processes, and neural structure and function. Effect size estimates will inform the sample size calculation for a future larger-scale trial.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Aug 2023 30 Nov 2025

Publications

2024 Protocol article in https://doi.org/10.1002/erv.3073 (added 05/02/2025)

Participation involves having two brain scans (before and after the intervention) and 20-sessions of real or sham (placebo) iTBS. In order to detect the effects of iTBS, not all participants will receive real iTBS, that is, half of the participants will receive a sham (placebo) iTBS stimulation. This will be random allocation and participants will not be aware of which (real or sham) stimulation they receive, however, will be informed upon completion of the 3-month follow-up assessment. Participants will also be required to complete a number of questionnaires, and neurocognitive tasks (brain puzzles) before and after the 20-sessions of real or sham iTBS. We will also collect blood samples for safety at baseline and mid-way through the 20-sessions.


Participants of any gender will be eligible if they have a current diagnosis of AN, are aged between 13-30 years old, have a BMI of >14kg/m² (for participants >18 years old) or 66% of the median BMI for age and gender (for participants <18 years old), and have completed at least one previous course of eating disorder treatment. Participants aged <16 years must have informed consent from parents or guardians.

You can take part if:



You may not be able to take part if:


1. Having a history of head or eye injury2. Having a current inpatient admission for AN treatment 3. Having a history of a neurological disease including previous seizures of any kind4. Having metallic implants anywhere in the head or body5. Being on a dose of any psychotropic medication that has not been stable for at least 14 days prior to participation in the study- Taking anti-convulsive medication6. Pregnancy or suspected pregnancy in female participants7. Having a current other major psychiatric disorder (e.g., major depressive disorder, bipolar illness, substance dependence, psychosis) needing treatment in its own right8. Excessive alcohol (scoring >5 on the AUDIT-C) and/or cigarette consumption (>15 cigarettes per day)9. Severe abnormalities in the screening clinical blood sample10. An rTMS safety questionnaire and an MRI safety questionnaire will also be administered and if deemed not safe to deliver rTMS or undergo MRI scanning, people will be excluded on this basis.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Institute of psychiatry, psychology and neuroscience
    16 De Crespigny Park
    London
    SE5 8AB

The most common side effect of iTBS is a mild discomfort in the scalp beneath the magnetic coil, but some people also referred to a mild headache (easily treated with simple analgesic drugs). The magnetic coil makes loud clicks during treatment that are not loud enough to harm hearing, but patients will be asked to wear earplugs as a precaution. An inbuilt safety mechanism in the machine keeps the coil at a safe temperature. Although iTBS is regarded as a safe intervention, the most serious side effect reported, though very rare, is a seizure (with an incidence of 0.02%). The rTMS Safety Screen will be done before iTBS and a daily evaluation of unintended effects (e.g., sensory sensations) with the iTBS will also be done with the TMS adverse events and associated sensations questionnaire. There are no risks associated with the administration of the neurocognitive tests and other questionnaires or MRI scans. Participants who receive real TBS may experience short and longer-term improvements in mood and eating disorder
symptoms.

Miss Amelia Hemmings
+44 2078485977
amelia.1.hemmings@kcl.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by King's College London and funded by UK Research and Innovation.



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Read full details for Trial ID: ISRCTN10474541

Or CPMS 57132

Last updated 05 February 2025

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