- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03984344
Theta Burst Stimulation in Anorexia Nervosa (ANTS)
A Feasibility Trial of Theta Burst Stimulation in Anorexia Nervosa (AN)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom
- Recruiting
- King's College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Active iTBS
iTBS 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.
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The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
Other Names:
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EXPERIMENTAL: Active cTBS
Continuous 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.
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The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
Other Names:
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SHAM_COMPARATOR: Sham TBS
Sham 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.
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The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes and differences between the 3 groups in core symptoms of AN from baseline to post-TBS
Time Frame: Baseline, within 1 hour after receiving [intermittent/continuous/sham] TBS, 24-hour follow-up
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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"
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Baseline, within 1 hour after receiving [intermittent/continuous/sham] TBS, 24-hour follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes and differences between the 3 groups in heart rate from baseline to post-TBS
Time Frame: Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
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Measures of heart rate (beats per minute) will be taken to assess cardiac safety of TBS in patients with AN
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Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
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Changes and differences between the 3 groups in blood pressure from baseline to post-TBS
Time Frame: Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
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Measures of blood pressure (millimetres of mercury; mmHg) will be taken to assess cardiac safety of TBS in patients with AN
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Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
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Differences between the 3 groups in self-reported ratings of discomfort experienced during TBS
Time Frame: Within 1 hour of receiving [intermittent/continuous/sham] TBS
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Discomfort experienced during TBS will be measured using a 10cm visual analogue scales (maximum score of 10).
Participants will be requested to indicate on this line a degree or level of discomfort experienced during TBS from "none" to "extreme discomfort"
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Within 1 hour of receiving [intermittent/continuous/sham] TBS
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Changes in performance on the Two-Step Sequential Learning Task from baseline to post-TBS
Time Frame: Baseline and within 1 hour of receiving [intermittent/continuous/sham] TBS
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Neuropsychological task measuring model-based and model-free reinforcement learning
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Baseline and within 1 hour of receiving [intermittent/continuous/sham] TBS
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCLANTS19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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