ACTRN12623001146684RecruitingUnknown
Functional Connectivity-informed Individualised Transcranial Magnetic Stimulation Therapy for Anorexia Nervosa (FUNCTIAN) – An Open-Label Proof of Concept Study
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Monash University
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •1.Diagnosis of anorexia nervosa (restrictive or binge-eating/purging subtype), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), of greater than 3 years duration.
- •2.18 years or older in age.
- •3.Baseline body mass index (BMI) between 15 and 18.
- •4.No initiation of therapies targeting AN within the 4 weeks prior to screening. This includes pharmacological and psychological therapies.
- •5.No increase or initiation of medications with appetite suppressing and/or weight loss effects within the 4 weeks prior to screening.
- •6.Demonstrated capacity to give informed consent.
- •7.Participants who are engaged with an existing clinical treatment team for their AN at the time of enrolment and over the course of trial participation. For this purpose, engagement is defined as maintaining clinical contact, on average, at least every 4 weeks.
- •8.Consent for the research team to communicate with the participant’s clinical treatment team in regard to a) Their progress through the trial and b) Communicate clinical deterioration and risks to allow facilitation of appropriate management, where clinically-indicated.
Exclusion Criteria
- •1.Inability to provide informed consent.
- •2.Hospitalisation within the 8 weeks prior to screening for treatment of medical compromise or instability resulting from AN.
- •3.Physical parameters meeting Criteria* for Medical Ward Admission as per the Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
- •a.High refeeding risk;
- •b.Vital signs as follows:
- •i.Systolic BP < 80 mmHg;
- •ii.Postural BP drop > 20 mmHg systolic, > 10 mmHg diastolic;
- •iii.Heart rate < 40 or > 110;
- •iv.Temperature < 35.5°C.
- •c.Blood tests within the preceding 7 days showing:
- •i.Blood Glucose <3.0 mmol/L
- •ii.Serum sodium <130 mmol/L
- •iii.Serum magnesium < 0.6 mmol/L
- •iv.Serum potassium <3.0 mmol/L
- •v.Serum phosphate <0.7 mmol/L
- •vi.Glomerular filtration rate < 60ml/min (Cockroft-Gault)
- •vii.Albumin <27 g/L
- •viii.Liver Enzymes ALT > 3 x upper limit of normal
- •ix.Neutrophils <1.0x10^9/L
- •*Unless the condition was assessed to be pre-existing or otherwise doesn’t present a severity of illness that should exclude the participant on the basis of safety, at the discretion of the study medical doctor.
- •4.Other clinically significant cardiac, respiratory, renal or endocrine conditions, or evidence of medical instability, at the discretion of the investigator.
- •5.Concomitant neurological disorder or a history of a seizure disorder.
- •6.Any contraindication to undergo MRI.
- •7.Participants who are pregnant.
- •8.Current substance use meeting DSM-5 criteria for substance use disorder, excluding nicotine use disorder.
- •9.Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder or delusional disorder as assessed by the Structured Clinical Interview for DSM-5 (SCID-5) at the time of screening.
- •10.Diagnosis of any other mental disorder that is the participant’s primary diagnosis or main mental health syndrome of concern at the time of screening, which may significantly affect psychiatric status and assessed as likely to impact trial participation, in the clinical judgement of the investigator.
Investigators
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