Anorexia NervosaANTSNCT03984344
Theta Burst Stimulation in Anorexia Nervosa
A study testing Intermittent Theta Burst Stimulation and Continuous 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 and Continuous Theta Burst Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Feb 2020to 1 Feb 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 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
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 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.
- Conditions
- Anorexia Nervosa
- Being tested
- Intermittent Theta Burst Stimulation, Continuous Theta Burst Stimulation, Sham 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.
Continuous Theta Burst StimulationDevice
Also called cTBS
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
Sham Theta Burst StimulationDevice
Also called Sham TBS
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
| 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 |
| Active cTBS | Experimental | 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. Receives: Device: Continuous Theta Burst Stimulation |
| Sham TBS | Sham comparator | 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. Receives: Device: Sham Theta Burst Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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
Measures of heart rate (beats per minute) will be taken to assess cardiac safety of TBS in patients with AN
Measured: 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
Measures of blood pressure (millimetres of mercury; mmHg) will be taken to assess cardiac safety of TBS in patients with AN
Measured: 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
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"
Measured: Within 1 hour of receiving [intermittent/continuous/sham] TBS
Changes in performance on the Two-Step Sequential Learning Task from baseline to post-TBS
Neuropsychological task measuring model-based and model-free reinforcement learning
Measured: Baseline and within 1 hour of receiving [intermittent/continuous/sham] TBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start18 Feb 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to one of three treatment arms: continuous TBS or intermittent TBS or sham TBS.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 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
- NCT03984344
- Sponsor's protocol ID
- KCLANTS19
- Acronym
- ANTS
- Status last verified
- Aug 2022
- First submitted
- 6 Jun 2019
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 Trial of Theta Burst Stimulation in Anorexia Nervosa (AN)
- ClinicalTrials.gov ID
- NCT03984344
- Acronym / sponsor ID
- ANTS / KCLANTS19
- 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
- 66 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 Feb 2023 (estimated)
- First posted
- 13 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, 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants will be randomly allocated to one of three treatment arms: continuous TBS or intermittent TBS or sham TBS.
| 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. |
| Active cTBS | Experimental | Device: Continuous Theta Burst StimulationContinuous 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 comparator | Device: Sham Theta Burst StimulationSham 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. |
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 re-feeding)
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 |
| Continuous Theta Burst StimulationAlso: cTBSThe Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS. | Device | Active cTBS |
| Sham Theta Burst StimulationAlso: Sham TBSThe Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil. | Device | Sham TBS |
Primary outcome
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
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"
4 secondary outcomes
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
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
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
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
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.
- Individual participant dataSharing planned: No
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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 and Continuous 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. Some participants in this study may receive a placebo. 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 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). 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.