Anorexia NervosaANTSNCT03979404
Theta Burst Stimulation in Anorexia Nervosa: A Case Series
A study testing Intermittent Theta Burst Stimulation in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 70 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Intermittent Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2020to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 refeeding)
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London
Lucy Gallop
About this study
Official title: A Feasibility Case Series of Theta Burst Stimulation in Anorexia Nervosa
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, called intermittent theta burst stimulation (iTBS). 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 feasibility case series is to obtain preliminary data on the longer-term (i.e. up to 6 months) effects of 20 sessions of iTBS on reducing core symptoms of AN.
- Conditions
- Anorexia Nervosa
- Being tested
- Intermittent Theta Burst Stimulation
- Keywords
- Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Transcranial Magnetic Stimulation, Anorexia Nervosa, Eating Disorders
- Medical subject headings
- Anorexia Nervosa, Mental Disorders, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Theta Burst StimulationDevice
Also called iTBS
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
| Study group | Role | What they receive |
|---|---|---|
| Active iTBS | Experimental | 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. Receives: Device: Intermittent Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in core symptoms of AN from baseline to post-treatment
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".
Measured: Throughout the study, lasting 7 months: baseline (before treatment), weekly throughout 4-weeks of treatment and 6 months after treatment (long-term follow-up)
Secondary outcomes (12)
Changes in performance on the Two-step Sequential Learning Task from baseline to post-treatment
Neuropsychological task measuring model-based and model-free reinforcement learning
Measured: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Food Choice Task from baseline to post-treatment
Neuropsychological task measuring decision making regarding food selection
Measured: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Face Affective Go No-Go Task from baseline to post-treatment
Neuropsychological task measuring information processing biases for positive and negative facial expressions
Measured: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Visual Probe Task from baseline to post-treatment
Neuropsychological task measuring information processing biases to high and low calorie foods
Measured: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Emotion Regulation Task from baseline to post-treatment
Neuropsychological task measuring heart rate variability (as an index of autonomic nervous system activity) during presentation of highly aversive pictures
Measured: 1 month: baseline (before treatment and post-treatment
Changes in self-reported perception of low mood from baseline to post-treatment
Low mood is measured on a 10cm visual analogue scale (maximum score 10). Participants are requested to indicate on this line a degree or level of experiencing "low mood" from "not at all" to "severe". Therefore a higher score reflects higher feelings of low mood.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of anxiety from baseline to post-treatment
Anxiety is measured on a 10cm visual analogue scale (maximum score 10). Participants are requested to indicate on this line a degree or level of experiencing "anxiety" from "not at all" to "severe". Therefore a higher score reflects higher feelings of anxiety.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of urge to exercise from baseline to post-treatment
Urge to exercise is measured on a 10cm visual analogue scale (maximum score 10). Participants are requested to indicate on this line a degree or level of experiencing "urge to exercise" from "not at all" to "severe". Therefore a higher score reflects a higher urge to exercise.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of urge to be sick/purge from baseline to post-treatment
Urge to be sick/purge is measured on a 10cm visual analogue scale (maximum score 10). Participants are requested to indicate on this line a degree or level of experiencing "urge to be sick/purge" from "not at all" to "severe". Therefore a higher score reflects a higher urge to be sick/purge.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in global scores on the Depression and Anxiety Stress Scale (DASS-21) from baseline to post-treatment
The DASS-21 is a self-report questionnaire of 21 items, 7 items per sub-scale: depression, anxiety and stress. Participants are asked to score every item on a scale from 0 (did not apply to me at all) to 3 (applied to me very much) based on how much each statement applies to them over the past week. Global score is computed by adding up the scores on the items per sub-scale and multiplying them by a factor 2, therefore higher scores reflecting more severe depressive symptoms. Global scores for the DASS-21 range between 0 and 120.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in global scores on the Eating Disorder Examination Questionnaire (EDE-Q) from baseline to post-treatment
The EDE-Q is a 28-item questionnaire that provides a measure of the range and severity of eating disorder features experienced over the past 28 days. The EDE-Q is scored using a 7-point, forced-choice rating scale (0-6) with higher scores reflecting a higher level of symptomatology. The EDE-Q yields a global score and four sub-scale scores: restraint, shape concern, weight concern, eating concern. The global score is calculated as the sum of the four sub-scale scores divided by the number of sub-scales (i.e. four). Global scores for the EDE-Q range between 0 and 6.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in body mass index (BMI; kg/m2) from baseline to post-treatment
BMI is a simple calculation of a person's height (m2; metres squared) and weight (kilograms). It is widely used as a general indicator of whether a person has a healthy body weight for their height.
Measured: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start18 Feb 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979404
- Sponsor's protocol ID
- KCLANTSCASE19
- Acronym
- ANTS
- Status last verified
- Aug 2022
- First submitted
- 4 Jun 2019
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Case Series of Theta Burst Stimulation in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03979404
- Acronym / sponsor ID
- ANTS / KCLANTSCASE19
- Conditions
- Anorexia Nervosa
- Keywords
- Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Transcranial Magnetic Stimulation, Anorexia Nervosa, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- South London and Maudsley NHS Foundation Trust
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, called intermittent theta burst stimulation (iTBS). 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 feasibility case series is to obtain preliminary data on the longer-term (i.e. up to 6 months) effects of 20 sessions of iTBS on reducing core symptoms of AN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active iTBS | Experimental | Device: Intermittent Theta Burst StimulationiTBS 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. |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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 refeeding)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Theta Burst StimulationAlso: iTBSThe Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS. | Device | Active iTBS |
Primary outcome
Changes in core symptoms of AN from baseline to post-treatment
Time frame: Throughout the study, lasting 7 months: baseline (before treatment), weekly throughout 4-weeks of treatment and 6 months after treatment (long-term follow-up)
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".
12 secondary outcomes
Changes in performance on the Two-step Sequential Learning Task from baseline to post-treatment
Time frame: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Food Choice Task from baseline to post-treatment
Time frame: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Face Affective Go No-Go Task from baseline to post-treatment
Time frame: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Visual Probe Task from baseline to post-treatment
Time frame: 1 month: baseline (before treatment) and post-treatment
Changes in performance on the Emotion Regulation Task from baseline to post-treatment
Time frame: 1 month: baseline (before treatment and post-treatment
Changes in self-reported perception of low mood from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of anxiety from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of urge to exercise from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in self-reported perception of urge to be sick/purge from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in global scores on the Depression and Anxiety Stress Scale (DASS-21) from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in global scores on the Eating Disorder Examination Questionnaire (EDE-Q) from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Changes in body mass index (BMI; kg/m2) from baseline to post-treatment
Time frame: 7 months: baseline (before treatment), post-treatment and at 6-month follow-up (long-term follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Theta Burst Stimulation in people with Anorexia Nervosa, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy J Gallop (+44 (0)2078485977, lucy.gallop@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in core symptoms of AN from baseline to post-treatment (time frame: Throughout the study, lasting 7 months: baseline (before treatment), weekly throughout 4-weeks of treatment and 6 months after treatment (long-term follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.