Trial of Enhanced Neurostimulation for Anorexia (TRENA)

The George Institute

Status: Enrolling

Conditions: Anorexia Nervosa

Treatments: Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637); Device: MagPro TMS device (ARTG: 204659)

Study type: Interventional

Funder types: Other

Identifiers

NCT05788042

2021-016

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 4 patient groups

Active transcranial Direct Current Stimulation (tDCS)

Active Comparator group

Description:

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).

Treatment:

Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)

Sham transcranial Direct Current Stimulation (tDCS)

Sham Comparator group

Description:

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.

Treatment:

Device: tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Active Comparator group

Description:

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.

Treatment:

Device: MagPro TMS device (ARTG: 204659)

Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham Comparator group

Description:

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.

Treatment:

Device: MagPro TMS device (ARTG: 204659)