Ursumando Luciana, Ponzo Viviana, Monteleone Alessio Maria, Menghini Deny, Fucà Elisa, Lazzaro Giulia, Esposito Romina, Picazio Silvia, Koch Giacomo, Zanna Valeria, Vicari Stefano, Costanzo Floriana
Child and Adolescent Neuropsychiatry Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, IRCCS, Piazza Sant'Onofrio 4, 00165, Rome, Italy.
Neurosurgery Unit, Department of Neuroscience, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
J Eat Disord. 2023 Aug 2;11(1):127. doi: 10.1186/s40337-023-00852-6.
Current psychological and pharmacological treatments for Anorexia Nervosa (AN) provide only moderate effective support, and there is an urgent need for research to improve therapies, especially in developing age. Non-invasive brain stimulation has suggested to have the potential to reducing AN symptomatology, via targeting brain alterations, such as hyperactivity of right prefrontal cortex (PFC). We suppose that transcranial direct current stimulation (tDCS) to the PFC may be effective in children and adolescents with AN.
We will conduct a randomized, double blind, add-on, placebo-controlled trial to investigate the efficacy of tDCS treatment on clinical improvement. We will also investigate brain mechanisms and biomarkers changes acting in AN after tDCS treatment. Eighty children or adolescent with AN (age range 10-18 years) will undergo treatment-as-usual including psychiatric, nutritional and psychological support, plus tDCS treatment (active or sham) to PFC (F3 anode/F4 cathode), for six weeks, delivered three times a week. Psychological, neurophysiological and physiological measures will be collected at baseline and at the end of treatment. Participants will be followed-up one, three, six months and one year after the end of treatment. Psychological measures will include parent- and self-report questionnaires on AN symptomatology and other psychopathological symptoms. Neurophysiological measures will include transcranial magnetic stimulation (TMS) with electroencephalography and paired pulse TMS and repetitive TMS to investigate changes in PFC connectivity, reactivity and plasticity after treatment. Physiological measures will include changes in the functioning of the endogenous stress response system, body mass index (BMI) and nutritional state.
We expect that tDCS treatment to improve clinical outcome by reducing the symptoms of AN assessed as changes in Eating Disorder Risk composite score of the Eating Disorder Inventory-3. We also expect that at baseline there will be differences between the right and left hemisphere in some electrophysiological measures and that such differences will be reduced after tDCS treatment. Finally, we expect a reduction of endogenous stress response and an improvement in BMI and nutritional status after tDCS treatment. This project would provide scientific foundation for new treatment perspectives in AN in developmental age, as well as insight into brain mechanisms acting in AN and its recovery. Trial registration The study was registered at ClinicalTrials.gov (ID: NCT05674266) and ethical approval for the study was granted by the local research ethics committee (process number 763_OPBG_2014).
目前针对神经性厌食症（AN）的心理和药物治疗仅提供中等程度的有效支持，迫切需要开展研究以改进治疗方法，尤其是针对发育年龄段的治疗。非侵入性脑刺激已显示出通过靶向脑改变（如右前额叶皮质（PFC）的过度活跃）来减轻AN症状的潜力。我们推测，对PFC进行经颅直流电刺激（tDCS）可能对患有AN的儿童和青少年有效。
我们将进行一项随机、双盲、附加、安慰剂对照试验，以研究tDCS治疗对临床改善的疗效。我们还将研究tDCS治疗后AN中起作用的脑机制和生物标志物变化。80名患有AN的儿童或青少年（年龄范围10 - 18岁）将接受常规治疗，包括精神、营养和心理支持，外加对PFC（F3阳极/F4阴极）进行tDCS治疗（活性或假刺激），为期六周，每周三次。在基线和治疗结束时收集心理、神经生理和生理测量数据。在治疗结束后1个月、3个月、6个月和1年对参与者进行随访。心理测量将包括关于AN症状和其他精神病理症状的家长报告和自我报告问卷。神经生理测量将包括经颅磁刺激（TMS）结合脑电图以及配对脉冲TMS和重复TMS，以研究治疗后PFC连接性、反应性和可塑性的变化。生理测量将包括内源性应激反应系统功能、体重指数（BMI）和营养状态的变化。
我们预计tDCS治疗可通过降低以进食障碍问卷-3的进食障碍风险综合评分变化评估的AN症状来改善临床结果。我们还预计在基线时，某些电生理测量中左右半球之间会存在差异，并且tDCS治疗后这种差异会减小。最后，我们预计tDCS治疗后内源性应激反应会降低，BMI和营养状况会改善。该项目将为发育年龄段AN的新治疗前景提供科学依据，并深入了解AN及其恢复过程中起作用的脑机制。试验注册该研究已在ClinicalTrials.gov注册（ID：NCT05674266），并且该研究已获得当地研究伦理委员会的伦理批准（程序编号763_OPBG_2014）。
