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Theta Burst Stimulation in Anorexia Nervosa: A Case Series

NCT03979404 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-19

No results posted yet for this study

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.

Conditions

  • Anorexia Nervosa

Interventions

DEVICE

Intermittent Theta Burst Stimulation

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2022-12-01
Completion
2023-01-01

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03979404 on ClinicalTrials.gov