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Efficacy and Safety of Deep Transcranial Magnetic Stimulation for Obsessive-Compulsive Disorder: A Prospective Multicenter Randomized Double-Blind Placebo-Controlled Trial
American Journal of Psychiatry ( IF 15.1 ) Pub Date : 2019-05-21 , DOI: 10.1176/appi.ajp.2019.18101180
Lior Carmi 1 , Aron Tendler 1 , Alexander Bystritsky 1 , Eric Hollander 1 , Daniel M. Blumberger 1 , Jeff Daskalakis 1 , Herbert Ward 1 , Kyle Lapidus 1 , Wayne Goodman 1 , Leah Casuto 1 , David Feifel 1 , Noam Barnea-Ygael 1 , Yiftach Roth 1 , Abraham Zangen 1 , Joseph Zohar 1
Affiliation  

Objective:

Obsessive-compulsive disorder (OCD) is a chronic and disabling condition that often responds unsatisfactorily to pharmacological and psychological treatments. Converging evidence suggests a dysfunction of the cortical-striatal-thalamic-cortical circuit in OCD, and a previous feasibility study indicated beneficial effects of deep transcranial magnetic stimulation (dTMS) targeting the medial prefrontal cortex and the anterior cingulate cortex. The authors examined the therapeutic effect of dTMS in a multicenter double-blind sham-controlled study.

Methods:

At 11 centers, 99 OCD patients were randomly allocated to treatment with either high-frequency (20 Hz) or sham dTMS and received daily treatments following individualized symptom provocation, for 6 weeks. Clinical response to treatment was determined using the Yale-Brown Obsessive Compulsive Scale (YBOCS), and the primary efficacy endpoint was the change in score from baseline to posttreatment assessment. Additional measures were response rates (defined as a reduction of ≥30% in YBOCS score) at the posttreatment assessment and after another month of follow-up.

Results:

Eighty-nine percent of the active treatment group and 96% of the sham treatment group completed the study. The reduction in YBOCS score among patients who received active dTMS treatment was significantly greater than among patients who received sham treatment (reductions of 6.0 points and 3.3 points, respectively), with response rates of 38.1% and 11.1%, respectively. At the 1-month follow-up, the response rates were 45.2% in the active treatment group and 17.8% in the sham treatment group. Significant differences between the groups were maintained at follow-up.

Conclusions:

High-frequency dTMS over the medial prefrontal cortex and anterior cingulate cortex significantly improved OCD symptoms and may be considered as a potential intervention for patients who do not respond adequately to pharmacological and psychological interventions.



中文翻译:

深层经颅磁刺激治疗强迫症的有效性和安全性:前瞻性多中心随机双盲安慰剂对照试验。

客观的:

强迫症(OCD)是一种慢性致残性疾病,通常对药理和心理治疗的反应不佳。越来越多的证据表明,强迫症患者的皮质-纹状体-丘脑-皮质回路功能异常,并且先前的一项可行性研究表明,针对内侧额前皮层和前扣带回皮层的深经颅磁刺激(dTMS)具有有益的作用。作者在多中心双盲假对照研究中检验了dTMS的治疗效果。

方法:

在11个中心,有99名强迫症患者被随机分配接受高频(20 Hz)或假dTMS治疗,并在个性化症状激怒后接受每日治疗,持续6周。使用耶鲁-布朗强迫症量表(YBOCS)确定对治疗的临床反应,主要疗效终点是评分从基线到治疗后评估的变化。其他措施包括在治疗后评估和随访后一个月的缓解率(定义为YBOCS评分降低≥30%)。

结果:

积极治疗组的89%和假治疗组的96%完成了研究。接受主动dTMS治疗的患者中YBOCS得分的降低幅度明显大于接受假治疗的患者(分别降低6.0分和3.3分),缓解率分别为38.1%和11.1%。随访1个月,积极治疗组的缓解率为45.2%,假治疗组的缓解率为17.8%。随访时两组之间保持显着差异。

结论:

内侧前额叶皮层和前扣带回皮层上的高频dTMS可以显着改善OCD症状,对于对药理和心理干预措施反应不佳的患者,可以将其视为潜在的干预措施。

更新日期:2019-11-01
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