Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Acceptability
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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. The following measures will be taken to ensure preservation of blinding to treatment allocation:
- Unblinded personnel (i.e., Neurostimulation Nurse(s) and/or tDCS research assistant), will be present during rTMS treatment delivery. tDCS will be self administered in the presence of ward staff. Team members involved in conducting blinded assessments for mood (i.e., MADRS) must not be present in the room during research treatment delivery.
- Knowledge of the code (i.e., which of 'A', 'B', 'C' or 'D' refers to which randomised treatment) will only be known to study staff responsible for treatment delivery, the study CI and study statistician involved in the study.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Acceptability
时间窗: 8 weeks
Number of completed sessions for active tDCS and active rTMS in the acute 8 week RCT period.
Effectiveness - Eating Disorder Examination Questionnaire (EDE Q)
时间窗: Change from baseline at 8 weeks
Self-report instrument that measures eating disorder behaviors and attitudes. Eating Disorder Examination Questionnaire; 28-items; rating scale 0 - 6; Higher scores on the global scale and subscales indicate more problematic eating behaviours and attitudes.
次要结局
- Neurocognition - STROOP Colour Word Test (response inhibition).(Change from baseline at 20 weeks)
- Number of re-admissions as reported by clinical staff.(From date of randomization until the date of study completion, assessed up to 20 weeks.)
- Duration of inpatient hospital stay as recorded by clinical staff(Through study completion, an average of 20 weeks)
- Change in Circumplex Scales of Interpersonal Efficacy (CSIE-32)(Change from baseline at 20 weeks)
- Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility)(Change from baseline at 20 weeks)
- Neurocognition - Embedded Figures Test (EFT: field dependence vs independence).(Change from baseline at 20 weeks)
- Weight(Change from baseline at 20 weeks)
- Mood - Montgomery Asberg Depression Rating Score (MADRS)(Change from baseline at 20 weeks)
- Neurocognition - Wisconsin Card Sorting Test (WSCT: perseveration).(Change from baseline at 20 weeks)
- Psychological Symptoms - Depression Anxiety and Stress Scale (DASS-21)(Change from baseline at 20 weeks)
- Cost of psychology sessions(Through study completion, an average of 20 weeks)
- Functioning - The Assessment of Quality of Life Instrument (AQoL-4D)(Change from baseline at 20 weeks)
- Total cost of costs of rTMS and tDCS administration(Through study completion, an average of 20 weeks)
- Number of psychology sessions(Through study completion, an average of 20 weeks)