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Theta Burst Stimulation in Anorexia Nervosa (ANTS)

Primary Purpose

Anorexia Nervosa

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intermittent Theta Burst Stimulation
Continuous Theta Burst Stimulation
Sham Theta Burst Stimulation
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa focused on measuring Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Transcranial Magnetic Stimulation, Anorexia Nervosa, Eating Disorders

Eligibility Criteria

13 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King's College LondonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Active iTBS

Active cTBS

Sham TBS

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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
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
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"
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

Full Information

First Posted
June 6, 2019
Last Updated
August 18, 2022
Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03984344
Brief Title
Theta Burst Stimulation in Anorexia Nervosa
Acronym
ANTS
Official Title
A Feasibility Trial of Theta Burst Stimulation in Anorexia Nervosa (AN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
South London and Maudsley NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Theta Burst Stimulation, Neuromodulation, Psychiatric Disorders, Transcranial Magnetic Stimulation, Anorexia Nervosa, Eating Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to one of three treatment arms: continuous TBS or intermittent TBS or sham TBS.
Masking
Participant
Masking Description
Researcher unable to be blinded as stimulation site is dependent on the participants allocation to intermittent or continuous TBS.
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active iTBS
Arm Type
Experimental
Arm Description
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.
Arm Title
Active cTBS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TBS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intermittent Theta Burst Stimulation
Other Intervention Name(s)
iTBS
Intervention Description
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
Intervention Type
Device
Intervention Name(s)
Continuous Theta Burst Stimulation
Other Intervention Name(s)
cTBS
Intervention Description
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
Intervention Type
Device
Intervention Name(s)
Sham Theta Burst Stimulation
Other Intervention Name(s)
Sham TBS
Intervention Description
The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
Primary Outcome Measure Information:
Title
Changes and differences between the 3 groups in core symptoms of AN from baseline to post-TBS
Description
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"
Time Frame
Baseline, within 1 hour after receiving [intermittent/continuous/sham] TBS, 24-hour follow-up
Secondary Outcome Measure Information:
Title
Changes and differences between the 3 groups in heart rate from baseline to post-TBS
Description
Measures of heart rate (beats per minute) will be taken to assess cardiac safety of TBS in patients with AN
Time Frame
Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
Title
Changes and differences between the 3 groups in blood pressure from baseline to post-TBS
Description
Measures of blood pressure (millimetres of mercury; mmHg) will be taken to assess cardiac safety of TBS in patients with AN
Time Frame
Baseline and within 1 hour after receiving [intermittent/continuous/sham] TBS
Title
Differences between the 3 groups in self-reported ratings of discomfort experienced during TBS
Description
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"
Time Frame
Within 1 hour of receiving [intermittent/continuous/sham] TBS
Title
Changes in performance on the Two-Step Sequential Learning Task from baseline to post-TBS
Description
Neuropsychological task measuring model-based and model-free reinforcement learning
Time Frame
Baseline and within 1 hour of receiving [intermittent/continuous/sham] TBS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucy J Gallop
Phone
+44 (0)2078485977
Email
lucy.gallop@kcl.ac.uk
Facility Information:
Facility Name
King's College London
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Gallop

12. IPD Sharing Statement

Plan to Share IPD
No

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Theta Burst Stimulation in Anorexia Nervosa

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