Rösch Sarah A, Wünsche Lennart, Thiele Carsten, Reinstaller Therese, Zähle Tino, Schag Kathrin, Giel Katrin E, Plewnia Christian, Steiner Johann, Junne Florian
University Clinic of Psychosomatic Medicine and Psychotherapy, University Hospital, Otto von Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany.
German Center for Mental Health (DZPG), Partner Site Halle-Jena-Magdeburg, Magdeburg, Germany.
J Eat Disord. 2024 Dec 9;12(1):202. doi: 10.1186/s40337-024-01160-3.
Notwithstanding the documented short- and long-term weight loss and remission of physical and mental diseases following bariatric surgery, a significant proportion of patients fail to respond (fully) to treatment in terms of physical and mental health improvement. Mounting evidence links food-specific impulsivity, prefrontal cortex (PFC) hypoactivity and disrupted hormone secretion in bariatric surgery candidates to poorer post-surgical health outcomes. Neuromodulatory treatments like transcranial direct current stimulation (tDCS) uniquely target these neurobehavioral impairments. We present a pilot study protocol offering tDCS combined with an inhibitory control training and a structured psychosocial intervention to patients after bariatric surgery.
A total of N = 20 patients are randomized to 6 sessions of verum or sham tDCS over the PFC, combined with an individualized food-specific inhibitory control training and a structured psychosocial intervention within 18 months after bariatric surgery (t0). Beyond acceptability, feasibility and satisfaction of the intervention, effects of verum versus sham tDCS on food-specific impulsivity and on secondary outcomes quality of life, general impulsivity and psychopathology, food-related cravings, eating disorder psychopathology, weight trajectory and endocrine markers are assessed 4 weeks (t1) and 3 months after the intervention (t2).
Results will provide information on the potential of combining tDCS with an inhibitory control training and a structured psychosocial intervention to enhance physical and mental outcomes after bariatric surgery. The present study may guide the development of future research with regard to tDCS as a brain-based intervention and of future post-surgical clinical programs, paving the way for randomized-controlled trials in larger samples.
The trial was prospectively registered on July 8, 2024, under the registration number DRKS00034620 in the German Clinical Trials Register ( https://drks.de/search/de/trial/DRKS00034620 ).
尽管有文献记载,减肥手术后患者在短期和长期内体重减轻,身心疾病得到缓解,但仍有相当一部分患者在身心健康改善方面对治疗没有(完全)反应。越来越多的证据表明,减肥手术候选者中特定食物冲动、前额叶皮质(PFC)活动不足以及激素分泌紊乱与术后较差的健康结果有关。像经颅直流电刺激(tDCS)这样的神经调节治疗专门针对这些神经行为障碍。我们提出了一项试点研究方案,为减肥手术后的患者提供tDCS,并结合抑制控制训练和结构化心理社会干预。
总共N = 20名患者被随机分为接受6次针对PFC的真刺激或假刺激tDCS,并在减肥手术后18个月内(t0)结合个性化的特定食物抑制控制训练和结构化心理社会干预。除了评估干预的可接受性、可行性和满意度外,还在干预后4周(t1)和3个月(t2)评估真刺激与假刺激tDCS对特定食物冲动以及次要结局生活质量、一般冲动和精神病理学、与食物相关的渴望、饮食障碍精神病理学、体重轨迹和内分泌标志物的影响。
研究结果将提供有关tDCS与抑制控制训练和结构化心理社会干预相结合以改善减肥手术后身心结局的潜力的信息。本研究可能会指导未来关于tDCS作为一种基于大脑的干预措施的研究以及未来术后临床项目的发展,为更大样本的随机对照试验铺平道路。
该试验于2024年7月8日在德国临床试验注册中心(https://drks.de/search/de/trial/DRKS00034620)进行前瞻性注册,注册号为DRKS00034620。