Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Australia
Northside Clinic
RECRUITING
Sydney
Contact Information
Primary
Donel Martin, Dr
donel.martin@unsw.edu.au
02 9382 8353
Time Frame
Start Date: 2023-08-02
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 70
Treatments
Active_comparator: Active transcranial Direct Current Stimulation (tDCS)
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_comparator: Sham transcranial Direct Current Stimulation (tDCS)
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.
Active_comparator: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
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_comparator: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Related Therapeutic Areas
Sponsors
Leads: The George Institute
Collaborators: The University of New South Wales

This content was sourced from clinicaltrials.gov