Condition category
Mental and Behavioural Disorders
Date applied
26/10/2009
Date assigned
04/11/2009
Last edited
18/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frederique Van den Eynde

ORCID ID

Contact details

Institute of Psychiatry
Section of Eating Disorders PO59
De Crespigny Park
London
SE5 8AF
United Kingdom
+ 44(0) 20 7848 0180
frederique.vandeneynde@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

07/H0807/90

Study information

Scientific title

A pilot investigation of the effects of repetitive transcranial magnetic stimulation (rTMS) in bulimic disorders: a two-armed double-blind randomised sham (placebo)-controlled trial

Acronym

Study hypothesis

Main hypothesis:
Compared to sham repetitive transcranial magnetic stimulation (rTMS), real rTMS applied to the left dorsolateral prefrontal cortex (DLPFC) will lead to greater reduction of cue-elicited food craving in people with a bulimic disorder.

The following subsidiary hypotheses will also be tested:
Compared to sham repetitive transcranial magnetic stimulation (rTMS), real rTMS applied to the left dorsolateral prefrontal cortex (DLPFC) in people with a bulimic disorder will lead to:
1. A greater reduction in bingeing behaviour in the 24 hours post-rTMS
2. A greater improvement in effect
3. A greater decrease in salivary cortisol levels (indicative of reduced stress levels)
4. A greater improvement in executive functioning (e.g. cognitive attentional control)

Ethics approval

The Joint South London and Maudsley and The Institute of Psychiatry NHS Research Ethics Committee approved on the 20th February 2008 (ref: 07/H0807/90)

Study design

Two-armed double-blind randomised sham (placebo)-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Bulimic eating disorders

Intervention

rTMS will be delivered with a Magstim Rapid device, with real and sham figure-eight coils (Magstim, Whitland, Wales, UK). Following mapping of the abductor pollicis brevis site in the left motor cortex, each participant’s motor threshold is established as the minimum stimulus required to induce contraction of the right thumb at least 5 of 10 times. The site for the left DLPFC stimulation is 5 cm anterior to the point of maximal abductor pollicis brevis stimulation. Twenty trains of 5 sec with 55-sec inter-train intervals are administered with a frequency of 10 Hz and intensity of 110% of the individual’s motor threshold, providing 1000 pulses over 20 minutes. Sham stimulation is given at the same location and frequency. The randomisation was stratified.

The intervention consisted of a single session (duration 20 minutes) of rTMS. The follow-up in both arms was 24 hours after the rTMS session.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The food craving score scored as 'urge to eat' on a 10 cm visual analogue scale (VAS) once before and once after real or sham rTMS (0 = no urge to eat at all; 10 extremely strong urge to eat).

Secondary outcome measures

1. The score on a 10 cm 'tension' VAS (0 = extremely calm; 10 = extreme tense) once just before and once just after real or sham rTMS
2. The score on a 10 cm 'mood' (0 = extremely low mood; 10 = extreme high mood) VAS once before and once after real or sham rTMS
3. The score on a 10 cm 'hunger' (0 = not hungry at all; 10 = extreme hungry) VAS once before and once after real or sham rTMS
4. The score on a 10 cm 'urge to binge-eat' (0 = no urge to binge eat; 10 = extreme strong urge to binge eat) VAS once before and once after real or sham rTMS
5. The score on a 10 cm 'urge to purge' (0 = no urge to be sick or purge; 10 extremely strong urge to be sick or purge) VAS once before and once after real or sham rTMS
6. The score on the Food Craving Questionnaire - State once before and once after real or sham rTMS
7. The number or participants who have a binge in the 24 hours period after real or sham rTMS, measured 24 hours after the real or sham rTMS session
8. The 'interference' score on the Stroop Colour Word Task once before and once after real or sham rTMS (calculated as the difference between time to complete the 'colour word' card and time to complete the 'colour' card)
9. Salivary cortisol levels (Salivette®) at four time points, two before and two after real or sham rTMS
10. Percentage of drop-out in real and sham rTMS, measured at the end of the real or sham rTMS session
11. Percentage of people reporting adverse-events after real of sham rTMS immediately after the real or sham rTMS session and 24 hours after the real or sham rTMS session

Overall trial start date

01/06/2008

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Outpatients
2. Male and female
3. Aged 18 to 60 years
4. Body mass index (BMI) higher than 17.5 kg/m^2
5. Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis of bulimia nervosa, binge eating disorder or eating disorder not otherwise specified (EDNOS) with a minimum of six binge episodes in the last 28 days (as assessed by the Eating Disorder Examination - Questionnaire [EDE-Q])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 participants

Participant exclusion criteria

1. Having a history of head or eye injury
2. Having a history of a neurological disease including previous seizures of any kind
3. Having metallic implants in the head
4. Being on a dose of any psychotropic medication that has not been stable for at least 14 days prior to participation in the study
5. Being pregnant
6. Smoking more than 10 cigarettes/day
7. Having any substance dependence
8. Participants who vomit on a regular basis (i.e. greater than 7 x a week), will be required to have a blood test to exclude those with electrolytes below the normal range
9. Participants will not have any other major psychiatric disorder needing treatment in its own right
10. Contraindications to rTMS as assessed with the Adult Safety Screen Questionnaire for rTMS
11. Being primarily left-handed

Recruitment start date

01/06/2008

Recruitment end date

01/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Psychiatry
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Jenny Liebscher
R&D Governance and Delivery Manager
SLam/IoP R&D Office
Room W 1.08
Institute of Psychiatry
De Crespigny Park
Denmark Hill
London
SE5 8AF
United Kingdom
+44(0) 20 7848 0251
Jennifer.Liebscher@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

King’s College London (UK) - Institute of Psychiatry, Department of Psychological Medicine, Section of Eating Disorders

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20060105

Publication citations

  1. Results

    Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U, Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders., Biol. Psychiatry, 2010, 67, 8, 793-795, doi: 10.1016/j.biopsych.2009.11.023.

Additional files

Editorial Notes