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| Name | Class |
|---|---|
| The University of New South Wales | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
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| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline at 8 weeks |
| Acceptability | Number of completed sessions for active tDCS and active rTMS in the acute 8 week RCT period. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in Body Mass Index. Weight status in AN is considered a key determinant of remission from illness. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donel Martin, Dr | Contact | 02 9382 8353 | donel.martin@unsw.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Sloane Madden, Assoc. Prof. | University of Sydney, Ramsay Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northside Clinic | Recruiting | Sydney | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23121779 | Background | 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. | |
| 23995026 | Background | First 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. |
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All de-identified data though with ethics approval and data transfer agreements required
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| ID | Term |
|---|---|
| D000856 | Anorexia Nervosa |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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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.
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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. The following measures will be taken to ensure preservation of blinding to treatment allocation:
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| 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. |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline at 20 weeks |
| Total cost of costs of rTMS and tDCS administration | Total cost of costs of rTMS and tDCS administration | 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 | 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 | From date of randomization until the date of study completion, assessed up to 20 weeks. |
| Number of psychology sessions | Number of psychology sessions | Through study completion, an average of 20 weeks |
| Cost of psychology sessions | Cost of psychology sessions in $ AUD | Through study completion, an average of 20 weeks |
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