Theta Burst Stimulation in Anorexia Nervosa
ANTS
A Feasibility Trial of Theta Burst Stimulation in Anorexia Nervosa (AN)
1 other identifier
interventional
66
1 country
1
Brief Summary
Anorexia Nervosa (AN) is a life-threatening eating disorder characterised by an intense fear of weight gain and disturbed body image, which motivates severe dietary restriction or other weight loss behaviours (e.g. purging). Treatment efficacy in adults with AN remains low: only a small percentage of individuals fully recover, and dropout rates are high. For adolescents with a relatively short term illness duration (under 3 years), family-based therapy has been associated with more favourable outcomes. However, for those adolescents with a longer illness duration (over 3 years), there are no specific treatments associated with positive long-term outcomes and these individuals are at risk of developing a severe and enduring form of the illness (SE-AN). In part, treatment can be problematic due to ambivalence, which is reflected in poor take-up of certain treatments (e.g. pharmacological treatments that lead to weight gain) and high drop-out rates. Repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy for treatment of AN in adults and improving treatment adherence. However, this has yet to be investigated in adolescents with AN. This study will use a novel type of rTMS, theta burst stimulation (TBS), including intermittent TBS (iTBS) and continuous TBS (cTBS). TBS takes as little as a few minutes duration compared to the classical rTMS protocol which takes approximately 37.5 minutes. In addition, TBS has been found to produce longer after-effects of the induced plastic changes and has a lower stimulation intensity, which may therefore be more practical and potentially safer to administer in people with AN. Thus, the aim of this proof-of-concept trial is to obtain preliminary data on the safety and short-term (i.e. up to 24 hours) effects of a single session of iTBS and cTBS, compared to sham TBS, on reducing core symptoms of AN.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2019
CompletedFirst Posted
Study publicly available on registry
June 13, 2019
CompletedStudy Start
First participant enrolled
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedAugust 19, 2022
August 1, 2022
2.8 years
June 6, 2019
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes and differences between the 3 groups in core symptoms of AN from baseline to post-TBS
Core symptoms of AN are computed by summing scores on three 10cm visual analogue scales (maximum score of 30) that assess levels of "urge to restrict", "feeling full", and "feeling fat". Participants are requested to indicate on this line a degree or level of experiencing the specific emotion or behavioural urge from "not at all" to "severe"
Baseline, within 1 hour after receiving [intermittent/continuous/sham] TBS, 24-hour follow-up
Secondary Outcomes (4)
Changes and differences between the 3 groups in heart rate from baseline to post-TBS
Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
Changes and differences between the 3 groups in blood pressure from baseline to post-TBS
Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
Differences between the 3 groups in self-reported ratings of discomfort experienced during TBS
Within 1 hour of receiving [intermittent/continuous/sham] TBS
Changes in performance on the Two-Step Sequential Learning Task from baseline to post-TBS
Baseline and within 1 hour of receiving [intermittent/continuous/sham] TBS
Study Arms (3)
Active iTBS
EXPERIMENTALiTBS will be delivered at 80% of resting motor threshold, consisting of a triplet of 50Hz bursts, repeated at 5Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 minutes and 9 seconds, to the left dorsolateral prefrontal cortex.
Active cTBS
EXPERIMENTALContinuous TBS will be delivered at 80% of RMT and will be applied as 600 pulses in a 40-second train of uninterrupted 50Hz bursts to the right dorsolateral prefrontal cortex.
Sham TBS
SHAM COMPARATORSham stimulation will be given at the right or left dorsolateral prefrontal cortex (counterbalanced) for 40 seconds or 3 minutes and 9 seconds (counterbalanced), at the same frequency as active TBS (50Hz), however a sham coil will be used.
Interventions
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
Eligibility Criteria
You may qualify if:
- Male and female participants over the age of 13
- BMI over 14 (for participants over the age of 18) or over 66% of the median BMI for age and gender (for participants under the age of 18)
- Right-handed
- Current Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of AN-restricting type (AN-R) or AN-binge/purge type (AN-BP) and an illness duration of 3 years or more
- 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 re-feeding)
- Participants under the age of 18 must have informed consent from parent(s)/carer(s)
- Must have approval from treating eating disorders clinician or general practitioner (GP) to participate
You may not qualify if:
- Having a history of head or eye injury
- Having a history of a neurological disease including previous seizures of any kind
- Having metallic implants anywhere in the head or body
- 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 antipsychotic medication
- Taking anti-convulsive medication
- Pregnancy or suspected pregnancy in female participants
- Having a current other major psychiatric disorder (e.g. major depressive disorder, substance dependence, schizophrenia or bipolar) needing treatment in its own right
- Excessive alcohol (\>3 units per day, 5 days of the week) and/or cigarette consumption (\>15 cigarettes per day)
- Severe abnormalities in the screening clinical blood sample
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King's College London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Researcher unable to be blinded as stimulation site is dependent on the participants allocation to intermittent or continuous TBS.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2019
First Posted
June 13, 2019
Study Start
February 18, 2020
Primary Completion
December 1, 2022
Study Completion
February 1, 2023
Last Updated
August 19, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share