Randomised controlled feasibility trial of intermittent theta burst stimulation (iTBS) for young people with persistent anorexia nervosa: RaISE

King's College London0 sites66 target enrollmentJune 1, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 1, 2023

End Date

August 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. Participants of any gender between the ages of 13 and 30 years
•2\. Living in the community (either in outpatient or day patient treatment, or with no current treatment for their AN).
•3\. BMI 14 kg/m² or above (for participants aged 18 years or above) or over 66% of the median BMI for age and gender (for participants under the age of 18\)
•4\. Current Diagnostic and Statistical Manual\-5 (DSM\-5\) diagnosis of AN\-restricting type (AN\-R) or AN\-binge/purging type (AN\-BP).
•5\. Must have completed at least one adequate previous course of eating disorder treatment (e.g., one 6\-month course of specialist outpatient therapy, specialist day\-care or in\-patient treatment for refeeding)
•6\. Participants under the age of 16 years must have informed consent from parent(s)/guardian(s) in addition to giving assent themselves
•7\. Those currently receiving treatment must have approval from treating eating disorder clinician or GP to participate. For those not currently receiving treatment, their GPs will be notified.
•8\. Must use and understand English as a language for everyday conversation

•1\. Having a history of head or eye injury
•2\. Having a current inpatient admission for AN treatment
•3\. Having a history of a neurological disease including previous seizures of any kind
•4\. Having metallic implants anywhere in the head or body
•5\. 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 medication
•6\. Pregnancy or suspected pregnancy in female participants
•7\. Having a current other major psychiatric disorder (e.g., major depressive disorder, bipolar illness, substance dependence, psychosis) needing treatment in its own right
•8\. Excessive alcohol (scoring \>5 on the AUDIT\-C) and/or cigarette consumption (\>15 cigarettes per day)
•9\. Severe abnormalities in the screening clinical blood sample
•10\. 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.