NCT03979404

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, 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 4, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

August 19, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

June 4, 2019

Last Update Submit

August 18, 2022

Conditions

Anorexia Nervosa

Keywords

Theta Burst StimulationNeuromodulationPsychiatric DisordersTranscranial Magnetic StimulationAnorexia NervosaEating Disorders

Outcome Measures

Primary Outcomes (1)

  • 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".

    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

    1 month: baseline (before treatment) and post-treatment

  • Changes in performance on the Food Choice Task from baseline to post-treatment

    1 month: baseline (before treatment) and post-treatment

  • Changes in performance on the Face Affective Go No-Go Task from baseline to post-treatment

    1 month: baseline (before treatment) and post-treatment

  • Changes in performance on the Visual Probe Task from baseline to post-treatment

    1 month: baseline (before treatment) and post-treatment

  • Changes in performance on the Emotion Regulation Task from baseline to post-treatment

    1 month: baseline (before treatment and post-treatment

  • +7 more secondary outcomes

Study Arms (1)

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.

Device: Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst StimulationDEVICE

The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.

Also known as: iTBS
Active iTBS

Eligibility Criteria

Age13 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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 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

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

RECRUITING

MeSH Terms

Conditions

Anorexia NervosaMental DisordersFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Lucy J Gallop

CONTACT

+44 (0)2078485977lucy.gallop@kcl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 7, 2019

Study Start

February 18, 2020

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

August 19, 2022

Record last verified: 2022-08

Locations

GB(1)