A pilot investigation of a single session of stimulation of the left frontal brain area applying a technique that delivers localised magnetic waves through the skull (repetitive transcranial magnetic stimulation [rTMS]) in people with a bulimic eating disorder (e.g. bulimia nervosa and binge-eating disorder) who engage in binge-eating behaviour and its effect on craving, bingeing behaviour and mood and stress

ISRCTN	ISRCTN95300084
DOI	https://doi.org/10.1186/ISRCTN95300084
Secondary identifying numbers	07/H0807/90

Submission date: 26/10/2009
Registration date: 04/11/2009
Last edited: 18/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Frederique Van den Eynde
Scientific

Institute of Psychiatry
Section of Eating Disorders PO59
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+ 44(0) 20 7848 0180
Email	frederique.vandeneynde@iop.kcl.ac.uk

Study information

Study design	Two-armed double-blind randomised sham (placebo)-controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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 participants 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 individuals 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
Primary outcome measure	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 study start date	01/06/2008
Completion date	01/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40 participants
Key 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])
Key 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
Date of first enrolment	01/06/2008
Date of final enrolment	01/05/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Psychiatry

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

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
England
United Kingdom

Phone	+44(0) 20 7848 0251
Email	Jennifer.Liebscher@kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/04/2010		Yes	No