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Trial registered on ANZCTR


Registration number
ACTRN12618001966280
Ethics application status
Approved
Date submitted
16/11/2018
Date registered
5/12/2018
Date last updated
5/12/2018
Date data sharing statement initially provided
5/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcranial direct current stimulation for the treatment of anorexia nervosa: A pilot study
Scientific title
High-Definition Transcranial Direct Current Stimulation (tDCS) of the Parietal Cortex in Anorexia Nervosa: A Pilot, Randomised Controlled Trial (RCT)
Secondary ID [1] 296470 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia nervosa 310255 0
Condition category
Condition code
Mental Health 308979 308979 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily high-definition transcranial direct current stimulation (HD-tDCS) will be administered to the left inferior parietal lobule for 20 minutes, for 10 days over two weeks (weekdays, excluding weekends). 2mA will be administered in a 4x1 electrode montage (electrode size approx 2cm). The montage will administer adonal stimulation (through an anodal central electrode and surrounding cathode electrodes). Stimulation will be preceded and followed by 30 seconds of ramping up and down, respectively. No speciific site preparation will be necessary, but alcohol wipes may be used to remove extra oils from the hair and skin. The stimulation sessions will occur at Swinburne Univeristy of Techology, The Melbourne Clinic or the Body Image & Eating Disorders Treatment & Recovery Service (BETRS), as preferred by the participant. The stimulation will be administered by a trained research assistant. Participants with anorexia nervosa will be randomised to receive the intervention or sham (placebo) stimulation in a double-blinded randomised controlled pilot investigation.
Intervention code [1] 312796 0
Treatment: Devices
Comparator / control treatment
Participants randomised to the sham condition will undergo the same HD-tDCS procedure as the active HD-tDCS group, and will not be aware that they have been allocated to receive inactive/sham tDCS. The sham condition will not involve active tDCS. The same ramp-up ramp-down procedure will take place for the sham condition so that participants are not aware of which group they are in. However, once 2mA has been reached in the ramp-up, it will come back down to 0 mA for the duration of the sham stimulation.
Control group
Placebo

Outcomes
Primary outcome [1] 307948 0
Eating Disorder Examination Questionnaire (full version and short-form)
Timepoint [1] 307948 0
Post-tDCS
Primary outcome [2] 307949 0
Composite outcome: Anorexia nervosa symptom scales designed for the study (Likert scale ratings including urge to eat, urge to exercise, urge to restrict, feeling of fatness, feeling of fullness, mood and anxiety)
Timepoint [2] 307949 0
post-tDCS
Primary outcome [3] 308134 0
Square wave jerk rate (atypical eye movement present in individuals with anorexia nervosa), This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [3] 308134 0
post-tDCS
Secondary outcome [1] 353441 0
Resting state functional connectivity of the inferior parietal lobule (magnetic resonance imaging; MRI)
Timepoint [1] 353441 0
post-tDCS
Secondary outcome [2] 354041 0
Eating Disorder Examination Questionnaire (full version and short-form)
Timepoint [2] 354041 0
4- and 12-weeks post-tDCS
Secondary outcome [3] 354042 0
Composite outcome: Anorexia nervosa symptom scales designed for the study (Likert scale ratings including urge to eat, urge to exercise, urge to restrict, feeling of fatness, feeling of fullness, mood and anxiety)
Timepoint [3] 354042 0
4- and 12-weeks post-tDCS
Secondary outcome [4] 354043 0
Square wave jerk rate (atypical eye movement present in individuals with anorexia nervosa). This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [4] 354043 0
4- and 12-weeks post-tDCS
Secondary outcome [5] 354051 0
Arterial spin labelling perfusion MRI
Timepoint [5] 354051 0
post-tDCS
Secondary outcome [6] 354053 0
Wisconsin card sorting test
Timepoint [6] 354053 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [7] 354054 0
Stunkard figure rating scale
Timepoint [7] 354054 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [8] 354055 0
Depression Anxiety Stress Scale
Timepoint [8] 354055 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [9] 354056 0
Dysmorphic Concern Questionnaire
Timepoint [9] 354056 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [10] 354057 0
State Trait Anxiety Inventory
Timepoint [10] 354057 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [11] 354058 0
Pittsburgh Sleep Quality Index
Timepoint [11] 354058 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [12] 354059 0
Sleep, Circadian Rhythms and Mood Questionnaire
Timepoint [12] 354059 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [13] 354060 0
Assessment of Quaity of Life (AqoL 8-D)
Timepoint [13] 354060 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [14] 354061 0
Body mass index (Tanita body composition monitor, measuring tape for height) (body weight divided by height in metres squared)
Timepoint [14] 354061 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [15] 354062 0
Composite outcome: Physical measurements (body fat %, body water %, muscle mass, bone mass, physique rating, basal metabolic rate, visceral fat rating, metabolic age). Measured with the Tanita body composition monitor.
Timepoint [15] 354062 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [16] 354063 0
Psychiatric diagnosis and comorbidities with the Mini International Neuropsychiatric Interview (MINI)
Timepoint [16] 354063 0
4- and 12-weeks post-tDCS
Secondary outcome [17] 354645 0
Eyetracking performance: Prosaccade task. This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [17] 354645 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [18] 354646 0
Eyetracking performance: Antisaccade task. This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [18] 354646 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [19] 354647 0
Eyetracking performance: Memory-guided saccade task. This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [19] 354647 0
post-tDCS, 4- and 12-weeks post-tDCS
Secondary outcome [20] 354648 0
Eyetracking performance: Scanpath task. This will be assessed with the EyeLink1000 Plus remote-view eyetracking system with a sampling rate of 1000Hz.
Timepoint [20] 354648 0
post-tDCS, 4- and 12-weeks post-tDCS

Eligibility
Key inclusion criteria
Inclusion criteria include being female, right-handed, English speaking, over 18 year of age and right-handed with a current diagnosis of anorexia nervosa according to DSM-5 criteria. All participants will be required to have ongoing medical support during the course of the intervention. All participants will also be required to be medically stable and stable on any medications for one month prior to inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be included in the study if they have a comorbid psychotic condition, substance/alcohol abuse/dependence, any history of neurological illness, any history of head injury, or any significant ocular pathology. Participants must not be undergoing any brain stimulation intervention currently, or in the past year. As participants will be required to undergo an MRI a number of further exclusions for safety purposes will be required including that the participant is not pregnant or breastfeeding, they do not have any irremovable metal (ferromagnetic metals) in their body and do not suffer from claustrophobia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed independently of the researchers and will have a block randomisation with a 1:1 allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Twenty participants (10 active HD-tDCS, 10 sham HD-tDCS) will be recruited for this pilot investigation. As this is a pilot study, a power caluclation has not been carried out.

Analyses will include mixed design analyses of variance (ANOVAs) and non-parametric assessments between groups and time points.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12306 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 12307 0
The Melbourne Clinic - Richmond
Recruitment postcode(s) [1] 24502 0
3065 - Fitzroy
Recruitment postcode(s) [2] 24503 0
3121 - Richmond

Funding & Sponsors
Funding source category [1] 301063 0
Charities/Societies/Foundations
Name [1] 301063 0
Swiss Anorexia Nervosa Foundation
Address [1] 301063 0
Klünenfeldstrasse 22
CH – 4127 Birsfelden
Switzerland
Country [1] 301063 0
Switzerland
Primary sponsor type
University
Name
Swinburne University of Technology
Address
John St
Hawthorn
VIC 3122
Country
Australia
Secondary sponsor category [1] 300675 0
None
Name [1] 300675 0
Address [1] 300675 0
Country [1] 300675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301817 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 301817 0
Research Governance Unit
St Vincent's Hospital, Melbourne
Fitzroy
VIC 3065
Ethics committee country [1] 301817 0
Australia
Date submitted for ethics approval [1] 301817 0
17/07/2018
Approval date [1] 301817 0
18/09/2018
Ethics approval number [1] 301817 0
SVHM HREC: 161/18; SERP HREC/18/SVHM/234
Ethics committee name [2] 301819 0
Swinburne University Human Research Ethics Committee
Ethics committee address [2] 301819 0
Swinburne University Human Research Ethics Committee
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [2] 301819 0
Australia
Date submitted for ethics approval [2] 301819 0
19/09/2018
Approval date [2] 301819 0
19/09/2018
Ethics approval number [2] 301819 0
2018/345
Ethics committee name [3] 301820 0
The Melbourne Clinic Human Research Ethics Committee
Ethics committee address [3] 301820 0
130 Church St
Richmond
VIC 3121
Ethics committee country [3] 301820 0
Australia
Date submitted for ethics approval [3] 301820 0
19/09/2018
Approval date [3] 301820 0
07/11/2018
Ethics approval number [3] 301820 0
TMC313

Summary
Brief summary
The aim of this study is to utilise a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) to assess it's efficacy in improving symptoms of anorexia nervosa. 20 individuals with anorexia nercosa will be randomised to receive tDCS to the inferior parietal lobe of the brrain, or sham tDCS, for 10 days over two weeks. They will complete assessments pre- and post-intervention including psychological assessments, eyetracking and magnetic resonance imaging (MRI).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88214 0
Dr Andrea Phillipou
Address 88214 0
Centre for Mental Health
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 88214 0
Australia
Phone 88214 0
+61 3 9214 8755
Fax 88214 0
Email 88214 0
andreaphillipou@swin.edu.au
Contact person for public queries
Name 88215 0
Dr Andrea Phillipou
Address 88215 0
Centre for Mental Health
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 88215 0
Australia
Phone 88215 0
+61 3 9214 8755
Fax 88215 0
Email 88215 0
andreaphillipou@swin.edu.au
Contact person for scientific queries
Name 88216 0
Dr Andrea Phillipou
Address 88216 0
Centre for Mental Health
Swinburne University of Technology
PO Box 218
Hawthorn
VIC 3122
Country 88216 0
Australia
Phone 88216 0
+61 3 9214 8755
Fax 88216 0
Email 88216 0
andreaphillipou@swin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Do not currently have ethics approval to share individual data
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable