Anorexia NervosaTRENANCT05788042
Trial of Enhanced Neurostimulation for Anorexia
A study testing MagPro TMS device (ARTG: 204659) and tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) in people with Anorexia Nervosa, run by The George Institute at 1 site in Australia.
Trial summary
Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- MagPro TMS device (ARTG: 204659) and tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Aug 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged ≥16 years,
- A current Diagnostic and Statistical Manual of Mental Disorders (5th edition DSM-5) diagnosis of anorexia nervosa
- Willing and able to participate and comply with study requirements
- Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing)
- Under ongoing care by his/her own treating psychiatrist (to ensure patient safety during the study)
Who cannot join
- Inability to provide informed consent
- Contraindications to tDCS/rTMS
- Failed to respond to an adequate course or rTMS (4 weeks) within the current illness course
- Had ECT in the last 3 months
- MoCA score of <26
- Significant risk of significant self harm or suicide as assessed by study psychiatrist(s)
- Currently enrolled in another interventional clinical trial or using an investigational device/product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Northside Clinic
Sydney, New South Wales, 2031
Sloane Madden, Assoc. Prof.
About this study
Official title: Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months).
Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities.
Read more
Participants will be recruited and treated at one inpatient setting (Northside Clinic, St Leonards, Sydney). This facility is one of the largest specialist eating disorder settings in Australia with approximately 130 new admissions every year (2019 data). All participants who give consent and who fulfill the eligibility criteria will be randomised to receive active tDCS, sham (placebo) tDCS, active rTMS or sham rTMS over 8 weeks. Trial participants, their treating psychiatrist, ward staff, and a study staff member (who will conduct blinded assessments of mood secondary outcome measures) will be blinded after assignment to intervention until the database is locked and the primary analysis completed. All participants will complete assessments of eating disorder symptoms, mood, psychological symptoms, neurocognition and functioning at baseline, end of week 4, 8 and 20.
Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS). The investigators expect that both active treatment arms will produce clinical benefits and have high acceptability, and that clinical benefits will be maintained with long-term at-home tDCS continuation treatment. These outcomes have potential to assist in reducing hospital stay and emergency re-admissions and improving day to day functioning in participants. Health economic data for both treatment modalities will additionally have utility from a service perspective, given the disparity in resource requirements between the two treatments (TMS, tDCS) in terms of costs for patients and access to treatment for people living in remote and rural areas (i.e., for at-home tDCS).
- Conditions
- Anorexia Nervosa
- Being tested
- MagPro TMS device (ARTG: 204659), tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
- Keywords
- Anorexia Nervosa, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, Non-invasive brain stimulation
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagPro TMS device (ARTG: 204659)Device
rTMS will be administered using a MagPro TMS device (ARTG: 204659) which is approved for its intended use in this trial. rTMS involves the application of transient magnetic pulses which induce small currents in the underlying cortex via the principal of electromagnetic induction. rTMS will be administered using a patterned frequency stimulus called intermittent theta-burst stimulation (iTBS).This form of rTMS was chosen because a recent large multicentre trial showed 3 minutes of iTBS attained the same therapeutic effect as 30 minutes of standard rTMS, leading to FDA approval for depression. Each treatment session will comprise an extended iTBS session, i.e., 6.6 mins, delivered at 100% resting motor threshold (RMT). It will be targeted to the left DLPFC (F3 using the 10-20 International EEG system), consistent with the prior RCT of rTMS for AN.
tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)Device
tDCS will be self-administered using the 1x1 tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) with two saline-soaked sponge electrodes held in place on the scalp using the Soterix Ole-2 headband. The device is intended to treat different neurological and psychiatric disorders. tDCS involves the passing of weak electrical current through the brain via electrodes placed upon the scalp. The current modulates the resting membrane potential of stimulated neurons which causes changes in neuronal excitability. The anode will be placed over the left F3 (10-20 System) and the cathode over F4 (electrode sizes 5 x 5cm, 25cm2). This montage was chosen to target the left DLPFC, consistent with prior pilot studies of tDCS in AN.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial Direct Current Stimulation (tDCS) | Active comparator | It will be given continuously for 30 minutes at 2 mA, twice daily (separated by >=2 hours) over the first 4 weeks, and daily over the second 4 weeks of the 8 week acute treatment period (84 sessions total). Receives: Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) |
| Sham transcranial Direct Current Stimulation (tDCS) | Sham comparator | It will involve an initial ramping up to 0.5 mA and then a ramp down to 0 mA for the remainder of each treatment. The same number of sessions as active tDCS will be administered. Receives: Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) |
| Active Repetitive Transcranial Magnetic Stimulation (rTMS) | Active comparator | Active rTMS twice per day (separated by ≥ 2 hours) over the first 4 weeks. Two sessions per day (separated by ≥ 2 hours), given on 2 days each week for the following 4 weeks. The total number of rTMS sessions over the 8 week acute treatment period will be 56. Receives: Device: MagPro TMS device (ARTG: 204659) |
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS) | Sham comparator | Sham rTMS twice per day (separated by ≥ 2 hours) over the first 4 weeks. Two sessions per day (separated by ≥ 2 hours), given on 2 days each week for the following 4 weeks. The same number of sessions as active rTMS will be administered. Receives: Device: MagPro TMS device (ARTG: 204659) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
Self-report instrument that measures eating disorder behaviors and attitudes. Eating Disorder Examination Questionnaire; 28-items; rating scale 0 - 6; Higher scores on the global scale and subscales indicate more problematic eating behaviours and attitudes.
Measured: Change from baseline at 8 weeks
Acceptability
Number of completed sessions for active tDCS and active rTMS in the acute 8 week RCT period.
Measured: 8 weeks
Secondary outcomes (25)
Weight
Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
Measured: Change from baseline at 4 weeks
Weight
Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
Measured: Change from baseline at 8 weeks
Weight
Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness.
Measured: Change from baseline at 20 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
Measured: Change from baseline at 4 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
Measured: Change from baseline at 8 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Depressive symptomology is a common psychiatric comorbidity of AN and both tDCS and rTMS significantly improve mood symptoms. 10-items; rating scale 0- 6; Higher score indicates more severe depression.
Measured: Change from baseline at 20 weeks
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Deficits in set shifting has been found to be common in people with AN.
Measured: Change from baseline at 8 weeks
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Deficits in set shifting has been found to be common in people with AN.
Measured: Change from baseline at 20 weeks
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
This task assesses central coherence, or the degree of focus on details in processing information. Poor central coherence is a potential etiologic or maintaining factor for people with eating disorders.
Measured: Change from baseline at 8 weeks
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
This task assesses central coherence, or the degree of focus on details in processing information. Poor central coherence is a potential etiologic or maintaining factor for people with eating disorders.
Measured: Change from baseline at 20 weeks
Neurocognition - STROOP Colour Word Test (response inhibition).
The STROOP task assesses inhibitory control, which has been shown to be reduced in people with eating disorders.
Measured: Change from baseline at 8 weeks
Neurocognition - STROOP Colour Word Test (response inhibition).
The STROOP task assesses inhibitory control, which has been shown to be reduced in people with eating disorders.
Measured: Change from baseline at 20 weeks
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
This task has been found to be sensitive to set shifting deficits in people with AN.
Measured: Change from baseline at 8 weeks
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
This task has been found to be sensitive to set shifting deficits in people with AN.
Measured: Change from baseline at 20 weeks
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Self reported questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. 21-items; rating scale 0- 3; Higher scores on subscales indicate more severe depression, anxiety and stress.
Measured: Change from baseline at 8 weeks
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Self reported questionnaire designed to measure the severity of a range of symptoms common to both Depression and Anxiety. 21-items; rating scale 0- 3; Higher scores on subscales indicate more severe depression, anxiety and stress.
Measured: Change from baseline at 20 weeks
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Measures quality of life for independent living, mental health, relationships, and senses. It as chosen as measures can be used for economic evaluation based on Quality Adjusted Life Years (QALYs). 12-items; scale 1-4; Higher score indicates lower health-related quality of life.
Measured: Change from baseline at 8 weeks
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Measures quality of life for independent living, mental health, relationships, and senses. It as chosen as measures can be used for economic evaluation based on Quality Adjusted Life Years (QALYs). 12-items; scale 1-4; Higher score indicates lower health-related quality of life.
Measured: Change from baseline at 20 weeks
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Change in Circumplex Scales of Interpersonal Efficacy: 32-items; scale 0-10; Higher score indicate confidence that one can engage in variety of interpersonal behaviours.
Measured: Change from baseline at 8 weeks
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Change in Circumplex Scales of Interpersonal Efficacy: 32-items; scale 0-10; Higher score indicate confidence that one can engage in variety of interpersonal behaviours.
Measured: Change from baseline at 20 weeks
Total cost of costs of rTMS and tDCS administration
Total cost of costs of rTMS and tDCS administration
Measured: Through study completion, an average of 20 weeks
Duration of inpatient hospital stay as recorded by clinical staff
Duration of inpatient hospital stay as recorded by clinical staff
Measured: Through study completion, an average of 20 weeks
Number of re-admissions as reported by clinical staff.
Number of re-admissions as reported by clinical staff
Measured: From date of randomization until the date of study completion, assessed up to 20 weeks.
Number of psychology sessions
Number of psychology sessions
Measured: Through study completion, an average of 20 weeks
Cost of psychology sessions
Cost of psychology sessions in $ AUD
Measured: Through study completion, an average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start2 Aug 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, sham-controlled trial, parallel group design. Participants will be randomised to one of four groups (2:1:2:1 ratio): Active or sham tDCS, or Active or sham rTMS. The brain stimulation protocols involve 84 sessions of tDCS (active or sham) or 56 sessions of rTMS (active or sham) over the 8 week acute treatment period.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Sloane Madden, Assoc. Prof., Principal investigator, University of Sydney, Ramsay Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788042
- Sponsor's protocol ID
- 2021-016
- Acronym
- TRENA
- Status last verified
- Apr 2025
- First submitted
- 21 Feb 2023
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified data though with ethics approval and data transfer agreements required
Publications
Aardoom JJ, Dingemans AE, Slof Op't Landt MC, Van Furth EF. Norms and discriminative validity of the Eating Disorder Examination Questionnaire (EDE-Q). Eat Behav. 2012 Dec;13(4):305-9. doi: 10.1016/j.eatbeh.2012.09.002. Epub 2012 Sep 19.
PubMed 23121779First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
PubMed 23995026Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10.
PubMed 31005790Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
PubMed 21727255Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534.
PubMed 30095685Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
PubMed 29726344Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
PubMed 32252538Couturier J, Lock J. What is remission in adolescent anorexia nervosa? A review of various conceptualizations and quantitative analysis. Int J Eat Disord. 2006 Apr;39(3):175-83. doi: 10.1002/eat.20224.
PubMed 16485268Dalton B, Bartholdy S, McClelland J, Kekic M, Rennalls SJ, Werthmann J, Carter B, O'Daly OG, Campbell IC, David AS, Glennon D, Kern N, Schmidt U. Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study. BMJ Open. 2018 Jul 16;8(7):e021531. doi: 10.1136/bmjopen-2018-021531.
PubMed 30012789Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
PubMed 27160468Fairburn, G.G. Cognitive Behavior Therapy and Eating Disorders. Guilford Press, New York, 2008.
Garber AK, Sawyer SM, Golden NH, Guarda AS, Katzman DK, Kohn MR, Le Grange D, Madden S, Whitelaw M, Redgrave GW. A systematic review of approaches to refeeding in patients with anorexia nervosa. Int J Eat Disord. 2016 Mar;49(3):293-310. doi: 10.1002/eat.22482. Epub 2015 Dec 12.
PubMed 26661289Hatch A, Madden S, Kohn M, Clarke S, Touyz S, Williams LM. Anorexia nervosa: towards an integrative neuroscience model. Eur Eat Disord Rev. 2010 May;18(3):165-79. doi: 10.1002/erv.974.
PubMed 20443202Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.
PubMed 15664172Katzman DK. Medical complications in adolescents with anorexia nervosa: a review of the literature. Int J Eat Disord. 2005;37 Suppl:S52-9; discussion S87-9. doi: 10.1002/eat.20118.
PubMed 15852321
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT05788042
- Acronym / sponsor ID
- TRENA / 2021-016
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Repetitive Transcranial Magnetic Stimulation, Transcranial Direct Current Stimulation, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months).
Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities.
Participants will be recruited and treated at one inpatient setting (Northside Clinic, St Leonards, Sydney). This facility is one of the largest specialist eating disorder settings in Australia with approximately 130 new admissions every year (2019 data). All participants who give consent and who fulfill the eligibility criteria will be randomised to receive active tDCS, sham (placebo) tDCS, active rTMS or sham rTMS over 8 weeks. Trial participants, their treating psychiatrist, ward staff, and a study staff member (who will conduct blinded assessments of mood secondary outcome measures) will be blinded after assignment to intervention until the database is locked and the primary analysis completed. All participants will complete assessments of eating disorder symptoms, mood, psychological symptoms, neurocognition and functioning at baseline, end of week 4, 8 and 20.
Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS). The investigators expect that both active treatment arms will produce clinical benefits and have high acceptability, and that clinical benefits will be maintained with long-term at-home tDCS continuation treatment. These outcomes have potential to assist in reducing hospital stay and emergency re-admissions and improving day to day functioning in participants. Health economic data for both treatment modalities will additionally have utility from a service perspective, given the disparity in resource requirements between the two treatments (TMS, tDCS) in terms of costs for patients and access to treatment for people living in remote and rural areas (i.e., for at-home tDCS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blind, randomised, sham-controlled trial, parallel group design. Participants will be randomised to one of four groups (2:1:2:1 ratio): Active or sham tDCS, or Active or sham rTMS. The brain stimulation protocols involve 84 sessions of tDCS (active or sham) or 56 sessions of rTMS (active or sham) over the 8 week acute treatment period.
| Arm | Type | Receives |
|---|---|---|
| Active transcranial Direct Current Stimulation (tDCS) | Active comparator | Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)It will be given continuously for 30 minutes at 2 mA, twice daily (separated by >=2 hours) over the first 4 weeks, and daily over the second 4 weeks of the 8 week acute treatment period (84 sessions total). |
| Sham transcranial Direct Current Stimulation (tDCS) | Sham comparator | Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)It will involve an initial ramping up to 0.5 mA and then a ramp down to 0 mA for the remainder of each treatment. The same number of sessions as active tDCS will be administered. |
| Active Repetitive Transcranial Magnetic Stimulation (rTMS) | Active comparator | Device: MagPro TMS device (ARTG: 204659)Active rTMS twice per day (separated by ≥ 2 hours) over the first 4 weeks. Two sessions per day (separated by ≥ 2 hours), given on 2 days each week for the following 4 weeks. The total number of rTMS sessions over the 8 week acute treatment period will be 56. |
| Sham Repetitive Transcranial Magnetic Stimulation (rTMS) | Sham comparator | Device: MagPro TMS device (ARTG: 204659)Sham rTMS twice per day (separated by ≥ 2 hours) over the first 4 weeks. Two sessions per day (separated by ≥ 2 hours), given on 2 days each week for the following 4 weeks. The same number of sessions as active rTMS will be administered. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥16 years,
- A current Diagnostic and Statistical Manual of Mental Disorders (5th edition DSM-5) diagnosis of anorexia nervosa
- Willing and able to participate and comply with study requirements
- Worked or studied in a context requiring some proficiency in spoken English (to ensure validity of neuropsychological testing)
- Under ongoing care by his/her own treating psychiatrist (to ensure patient safety during the study)
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Contraindications to tDCS/rTMS
- Failed to respond to an adequate course or rTMS (4 weeks) within the current illness course
- Had ECT in the last 3 months
- MoCA score of <26
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagPro TMS device (ARTG: 204659)rTMS will be administered using a MagPro TMS device (ARTG: 204659) which is approved for its intended use in this trial. rTMS involves the application of transient magnetic pulses which induce small currents in the underlying cortex via the principal of electromagnetic induction. rTMS will be administered using a patterned frequency stimulus called intermittent theta-burst stimulation (iTBS).This form of rTMS was chosen because a recent large multicentre trial showed 3 minutes of iTBS attained the same therapeutic effect as 30 minutes of standard rTMS, leading to FDA approval for depression. Each treatment session will comprise an extended iTBS session, i.e., 6.6 mins, delivered at 100% resting motor threshold (RMT). It will be targeted to the left DLPFC (F3 using the 10-20 International EEG system), consistent with the prior RCT of rTMS for AN. | Device | Active Repetitive Transcranial Magnetic Stimulation (rTMS), Sham Repetitive Transcranial Magnetic Stimulation (rTMS) |
| tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)tDCS will be self-administered using the 1x1 tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) with two saline-soaked sponge electrodes held in place on the scalp using the Soterix Ole-2 headband. The device is intended to treat different neurological and psychiatric disorders. tDCS involves the passing of weak electrical current through the brain via electrodes placed upon the scalp. The current modulates the resting membrane potential of stimulated neurons which causes changes in neuronal excitability. The anode will be placed over the left F3 (10-20 System) and the cathode over F4 (electrode sizes 5 x 5cm, 25cm2). This montage was chosen to target the left DLPFC, consistent with prior pilot studies of tDCS in AN. | Device | Active transcranial Direct Current Stimulation (tDCS), Sham transcranial Direct Current Stimulation (tDCS) |
Primary outcome
Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
Time frame: Change from baseline at 8 weeks
Self-report instrument that measures eating disorder behaviors and attitudes. Eating Disorder Examination Questionnaire; 28-items; rating scale 0 - 6; Higher scores on the global scale and subscales indicate more problematic eating behaviours and attitudes.
Acceptability
Time frame: 8 weeks
Number of completed sessions for active tDCS and active rTMS in the acute 8 week RCT period.
25 secondary outcomes
Weight
Time frame: Change from baseline at 4 weeks
Weight
Time frame: Change from baseline at 8 weeks
Weight
Time frame: Change from baseline at 20 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Time frame: Change from baseline at 4 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Time frame: Change from baseline at 8 weeks
Mood - Montgomery Asberg Depression Rating Score (MADRS)
Time frame: Change from baseline at 20 weeks
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Time frame: Change from baseline at 8 weeks
Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
Time frame: Change from baseline at 20 weeks
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
Time frame: Change from baseline at 8 weeks
Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
Time frame: Change from baseline at 20 weeks
Neurocognition - STROOP Colour Word Test (response inhibition).
Time frame: Change from baseline at 8 weeks
Neurocognition - STROOP Colour Word Test (response inhibition).
Time frame: Change from baseline at 20 weeks
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
Time frame: Change from baseline at 8 weeks
Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
Time frame: Change from baseline at 20 weeks
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Time frame: Change from baseline at 8 weeks
Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
Time frame: Change from baseline at 20 weeks
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Time frame: Change from baseline at 8 weeks
Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
Time frame: Change from baseline at 20 weeks
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Time frame: Change from baseline at 8 weeks
Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
Time frame: Change from baseline at 20 weeks
Total cost of costs of rTMS and tDCS administration
Time frame: Through study completion, an average of 20 weeks
Duration of inpatient hospital stay as recorded by clinical staff
Time frame: Through study completion, an average of 20 weeks
Number of re-admissions as reported by clinical staff.
Time frame: From date of randomization until the date of study completion, assessed up to 20 weeks.
Number of psychology sessions
Time frame: Through study completion, an average of 20 weeks
Cost of psychology sessions
Time frame: Through study completion, an average of 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 23121779Aardoom JJ, Dingemans AE, Slof Op't Landt MC, Van Furth EF. Norms and discriminative validity of the Eating Disorder Examination Questionnaire (EDE-Q). Eat Behav. 2012 Dec;13(4):305-9. doi: 10.1016/j.eatbeh.2012.09.002. Epub 2012 Sep 19.
- Background: PubMed 23995026First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
- Background: PubMed 31005790Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10.
- Background: PubMed 21727255Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74.
- Background: PubMed 30095685Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534.
- Background: PubMed 29726344Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.
- Background: PubMed 32252538Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Psychiatry. 2020 Aug 1;177(8):716-726. doi: 10.1176/appi.ajp.2019.19070720. Epub 2020 Apr 7.
- Background: PubMed 16485268Couturier J, Lock J. What is remission in adolescent anorexia nervosa? A review of various conceptualizations and quantitative analysis. Int J Eat Disord. 2006 Apr;39(3):175-83. doi: 10.1002/eat.20224.
- Background: PubMed 30012789Dalton B, Bartholdy S, McClelland J, Kekic M, Rennalls SJ, Werthmann J, Carter B, O'Daly OG, Campbell IC, David AS, Glennon D, Kern N, Schmidt U. Randomised controlled feasibility trial of real versus sham repetitive transcranial magnetic stimulation treatment in adults with severe and enduring anorexia nervosa: the TIARA study. BMJ Open. 2018 Jul 16;8(7):e021531. doi: 10.1136/bmjopen-2018-021531.
- Background: PubMed 27160468Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
- BackgroundFairburn, G.G. Cognitive Behavior Therapy and Eating Disorders. Guilford Press, New York, 2008.
- Background: PubMed 26661289Garber AK, Sawyer SM, Golden NH, Guarda AS, Katzman DK, Kohn MR, Le Grange D, Madden S, Whitelaw M, Redgrave GW. A systematic review of approaches to refeeding in patients with anorexia nervosa. Int J Eat Disord. 2016 Mar;49(3):293-310. doi: 10.1002/eat.22482. Epub 2015 Dec 12.
- Individual participant dataSharing planned: Yes. All de-identified data though with ethics approval and data transfer agreements required
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sloane Madden, Assoc. Prof. principal investigator
University of Sydney, Ramsay Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagPro TMS device (ARTG: 204659) and tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) in people with Anorexia Nervosa, run by The George Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donel Martin, Dr (02 9382 8353, donel.martin@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness - Eating Disorder Examination Questionnaire (EDE Q) (time frame: Change from baseline at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788042, which also lists 40 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.