Clinical trial NCT05788042: Trial of Enhanced Neurostimulation for Anorexia
Official title: Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Non-invasive brain stimulation
Lead sponsor: The George Institute
Sponsor class: OTHER
Collaborators: name: The University of New South Wales
First posted: 2023-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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).


Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
timeFrame: Change from baseline at 8 weeks
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Weight
timeFrame: Change from baseline at 4 weeks
measure: Weight
timeFrame: Change from baseline at 8 weeks
measure: Weight
timeFrame: Change from baseline at 20 weeks
measure: Mood - Montgomery Asberg Depression Rating Score (MADRS)
timeFrame: Change from baseline at 4 weeks
measure: Mood - Montgomery Asberg Depression Rating Score (MADRS)
timeFrame: Change from baseline at 8 weeks
measure: Mood - Montgomery Asberg Depression Rating Score (MADRS)
timeFrame: Change from baseline at 20 weeks
measure: Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
timeFrame: Change from baseline at 8 weeks
measure: Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)
timeFrame: Change from baseline at 20 weeks
measure: Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
timeFrame: Change from baseline at 8 weeks
measure: Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).
timeFrame: Change from baseline at 20 weeks
measure: Neurocognition - STROOP Colour Word Test (response inhibition).
timeFrame: Change from baseline at 8 weeks
measure: Neurocognition - STROOP Colour Word Test (response inhibition).
timeFrame: Change from baseline at 20 weeks
measure: Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
timeFrame: Change from baseline at 8 weeks
measure: Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).
timeFrame: Change from baseline at 20 weeks
measure: Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Change from baseline at 8 weeks
measure: Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)
timeFrame: Change from baseline at 20 weeks
measure: Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
timeFrame: Change from baseline at 8 weeks
measure: Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)
timeFrame: Change from baseline at 20 weeks
measure: Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
timeFrame: Change from baseline at 8 weeks
measure: Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)
timeFrame: Change from baseline at 20 weeks
measure: Total cost of costs of rTMS and tDCS administration
timeFrame: Through study completion, an average of 20 weeks
measure: Duration of inpatient hospital stay as recorded by clinical staff
timeFrame: Through study completion, an average of 20 weeks
measure: Number of re-admissions as reported by clinical staff.
timeFrame: From date of randomization until the date of study completion, assessed up to 20 weeks.
measure: Number of psychology sessions
timeFrame: Through study completion, an average of 20 weeks
measure: Cost of psychology sessions
timeFrame: Through study completion, an average of 20 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Northside Clinic
state: New South Wales
Study officials:
affiliation: University of Sydney, Ramsay Health Care
name: Sloane Madden, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
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