Intermittent theta burst stimulation for young people with persistent anorexia nervosa

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10474541

Enrollment

Registered

2023-06-01

Start date

2023-08-30

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia nervosa Mental and Behavioural Disorders

Interventions

66 participants will be randomised to receive real or sham iTBS in a parallel group, triple-blind study design. Intermittent theta burst stimulation (iTBS) consists of a coil that is held by the res

AN subtype: restrictive or binge-purge) into the web-based CTU system. Participants will then be allocated to either real or sham iT

Eligibility

Sex/Gender

All

Age

13 Years to 30 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Retention of participants in the study measured via percentage of participants retained out of total number of participants randomised, at 4-months.	—

Secondary

Measure	Time frame
1. Acceptability, measured via adherence to 20-sessions of iTBS, TMS adverse events and associated sensations questionnaire (administered at each daily iTBS session), and qualitative interviews scheduled after unblinding at 4-month follow-up. 2. Credibility of iTBS, measured via qualitative interviews scheduled after unblinding at 4-month follow up. 3. Recruitment rates measured via number of participants recruited per site per month. 4. Attendance rates measured by sessions of real or sham iTBS completed out of 20, at the end of treatment (1-month). 5. Determining the best instruments for measuring outcomes in a full trial by examining the quality, completeness, and variability in the data measured throughout the trial (at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up) 6. Estimating the treatment effect sizes and standard deviations for clinical outcome measures (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up) to inform the sample size calculation for a larger-scale trial. 7. Safety of TBS for young people, via cardiac measures collected weekly throughout the 4-week trial period, and a questionnaire measuring TMS adverse effects and associated sensations administered daily at each iTBS session. 8. Eating disorder symptoms (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up, and again at open-longer term follow-ups at 12- and 24-months post-randomisation). 9. Other related clinical symptoms, measured by scores on clinical symptom questionnaires and visual analogue scales (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up, and again at open-longer term follow-ups at 12- and 24-months post-randomisation). 10. Changes to brain structure and function, measured by structural MRI, arterial spin labelling, task-negative and task-based functional MRI (fMRI), associated with behavioural and symptom change following TBS, from	—

Measure

Time frame

1. Acceptability, measured via adherence to 20-sessions of iTBS, TMS adverse events and associated sensations questionnaire (administered at each daily iTBS session), and qualitative interviews scheduled after unblinding at 4-month follow-up. 2. Credibility of iTBS, measured via qualitative interviews scheduled after unblinding at 4-month follow up. 3. Recruitment rates measured via number of participants recruited per site per month. 4. Attendance rates measured by sessions of real or sham iTBS completed out of 20, at the end of treatment (1-month). 5. Determining the best instruments for measuring outcomes in a full trial by examining the quality, completeness, and variability in the data measured throughout the trial (at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up) 6. Estimating the treatment effect sizes and standard deviations for clinical outcome measures (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up) to inform the sample size calculation for a larger-scale trial. 7. Safety of TBS for young people, via cardiac measures collected weekly throughout the 4-week trial period, and a questionnaire measuring TMS adverse effects and associated sensations administered daily at each iTBS session. 8. Eating disorder symptoms (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up, and again at open-longer term follow-ups at 12- and 24-months post-randomisation). 9. Other related clinical symptoms, measured by scores on clinical symptom questionnaires and visual analogue scales (measured at baseline, daily during the 20-sessions, at post-treatment, 4-month follow-up, and again at open-longer term follow-ups at 12- and 24-months post-randomisation). 10. Changes to brain structure and function, measured by structural MRI, arterial spin labelling, task-negative and task-based functional MRI (fMRI), associated with behavioural and symptom change following TBS, from

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026