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Trial of Enhanced Neurostimulation for Anorexia

RecruitingNAAges 16 Years - anyAllThe George Institute
NCT05788042 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 eligibi

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • MagPro TMS device (ARTG: 204659)
  • tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
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Where

1 site
Northside Clinic
Sydney, Australia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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