在精神分裂症患者中提达爆发rTMS以改善负面和认知症状:双盲,假控,随机临床试验的研究协议
Gábor Csukly1, Boglárka Orbán-Szigeti2, Karolin Suri3
1Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa 6, Budapest, 1083, Hungary. csugab@yahoo.com.
Trials
|April 17, 2024
概括
这项研究研究了针对精神分裂症的增强的甲爆跨磁刺激 (TMS) 协议,针对负面症状和社会认知. 预计结果将在接受活性治疗的患者中显著改善,与假药治疗相比.
科学领域:
- 神经科学是一个神经科学.
- 精神病学是一个精神病学.
- 医疗器械 医疗器械
背景情况:
- 传统的精神分裂症治疗方法,包括抗精神病药物和心理社会干预措施,在减少负面和认知症状方面表现出有限的有效性.
- 新出现的证据表明,增强的协议,如甲爆刺激,可以提高重复性跨磁刺激 (rTMS) 在抑郁症的疗效,但精神分裂症的数据很少.
- 个体网络损伤模式可能解释患者对特定刺激位置的不同反应.
研究的目的:
- 评估增强的甲爆 (TBS) 协议的疗效和安全性,用于治疗精神分裂症的负面症状.
- 研究这种增强型TBS协议对认知灵活性,执行功能,记忆,社会认知和面部情绪识别的影响.
- 为了比较积极的TBS治疗与精神分裂症患者的假治疗的结果.
主要方法:
- 这是一项双盲,假控制,随机的研究,涉及90名精神分裂症患者 (18-55岁) 具有负面症状.
- 参与者被随机分配1:1接受活跃或虚假的TBS,每天针对左背侧前额皮质 (DLPFC) 和大脑虫,持续4周.
- 该协议涉及到每个位置的1800个刺激,使用标准TBS参数 (5Hz,100%的活跃电机值),以正负综合征量表 (PANSS) 作为主要结果量.
主要成果:
- 主要终点是通过PANSS测量的负症状严重程度的变化.
- 二级终点包括认知灵活性,执行功能,短期记忆,社会认知和面部情绪识别的改善.
- 安全性将通过监测严重不良事件来评估.
结论:
- 这项研究评估了增强的甲型爆发式rTMS治疗精神分裂症的疗效和安全性.
- 假设主动治疗将导致与假装治疗相比,社会认知和负面症状的显著改善.
- 这些发现旨在提供证据,为精神分裂症管理提供一种新的,增强的rTMS方法.
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