Trial of Enhanced Neurostimulation for Anorexia

Официальное название

Randomised Controlled Trial of Neurostimulation for Symptoms of Anorexia Nervosa

Обзор

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).

Вмешательства

• Устройство MagPro TMS device (ARTG: 204659)
  rTMS will be administered using a MagPro TMS device (ARTG: 204659) which is approved for its intended use in this trial. rTMS involves the application of transient magnetic pulses which induce small currents in the underlying cortex via the principal of electromagnetic induction. rTMS will be administered using a patterned frequency stimulus called intermittent theta-burst stimulation (iTBS).This form of rTMS was chosen because a recent large multicentre trial showed 3 minutes of iTBS attained t
• Устройство tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637)
  tDCS will be self-administered using the 1x1 tDCS mini-CT Stimulator (Soterix, USA: ARTG: 284637) with two saline-soaked sponge electrodes held in place on the scalp using the Soterix Ole-2 headband. The device is intended to treat different neurological and psychiatric disorders. tDCS involves the passing of weak electrical current through the brain via electrodes placed upon the scalp. The current modulates the resting membrane potential of stimulated neurons which causes changes in neuronal e

Первичные конечные точки

• Effectiveness - Eating Disorder Examination Questionnaire (EDE Q) [Срок оценки: Change from baseline at 8 weeks]
• Acceptability [Срок оценки: 8 weeks]

Вторичные конечные точки (12)

• Weight [Срок оценки: Change from baseline at 4 weeks]
• Weight [Срок оценки: Change from baseline at 8 weeks]
• Weight [Срок оценки: Change from baseline at 20 weeks]
• Mood - Montgomery Asberg Depression Rating Score (MADRS) [Срок оценки: Change from baseline at 4 weeks]
• Mood - Montgomery Asberg Depression Rating Score (MADRS) [Срок оценки: Change from baseline at 8 weeks]
• Mood - Montgomery Asberg Depression Rating Score (MADRS) [Срок оценки: Change from baseline at 20 weeks]
• Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility) [Срок оценки: Change from baseline at 8 weeks]
• Neurocognition - Trail Making Test parts A and B (TMT: attention and cognitive flexibility) [Срок оценки: Change from baseline at 20 weeks]
• Neurocognition - Embedded Figures Test (EFT: field dependence vs independence). [Срок оценки: Change from baseline at 8 weeks]
• Neurocognition - Embedded Figures Test (EFT: field dependence vs independence). [Срок оценки: Change from baseline at 20 weeks]
• Neurocognition - STROOP Colour Word Test (response inhibition). [Срок оценки: Change from baseline at 8 weeks]
• Neurocognition - STROOP Colour Word Test (response inhibition). [Срок оценки: Change from baseline at 20 weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Австралия · 1 центр

• Northside Clinic — Sydney

Публикации

• Aardoom JJ, Dingemans AE, Slof Op't Landt MC, Van Furth EF. Norms and discriminative validity of the Eating Disorder Examination Questionnaire (EDE-Q). Eat Behav. 2012 Dec;13(4):305-9. doi: 10.1016/j.eatbeh.2012.09.002. Epub 2012 Sep 19. PMID 23121779
• First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available. PMID 23995026
• Alonzo A, Fong J, Ball N, Martin D, Chand N, Loo C. Pilot trial of home-administered transcranial direct current stimulation for the treatment of depression. J Affect Disord. 2019 Jun 1;252:475-483. doi: 10.1016/j.jad.2019.04.041. Epub 2019 Apr 10. PMID 31005790
• Arcelus J, Mitchell AJ, Wales J, Nielsen S. Mortality rates in patients with anorexia nervosa and other eating disorders. A meta-analysis of 36 studies. Arch Gen Psychiatry. 2011 Jul;68(7):724-31. doi: 10.1001/archgenpsychiatry.2011.74. PMID 21727255
• Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534. PMID 30095685
• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. PMID 29726344
• Cole EJ, Stimpson KH, Bentzley BS, Gulser M, Cherian K, Tischler C, Nejad R, Pankow H, Choi E, Aaron H, Espil FM, Pannu J, Xiao X, Duvio D, Solvason HB, Hawkins J, Guerra A, Jo B, Raj KS, Phillips AL, Barmak F, Bishop JH, Coetzee JP, DeBattista C, Keller J, Schatzberg AF, Sudheimer KD, Williams NR. Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression. Am J Ps PMID 32252538
• Couturier J, Lock J. What is remission in adolescent anorexia nervosa? A review of various conceptualizations and quantitative analysis. Int J Eat Disord. 2006 Apr;39(3):175-83. doi: 10.1002/eat.20224. PMID 16485268

Идентификаторы

NCT: NCT05788042 · 2021-016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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