Conelea Christine, Breitenfeldt Claire, Wilens Alixandra, Carpenter Linda, Greenberg Benjamin, Herren Jennifer, Jacob Suma, Lewis Charles, McLaughlin Nicole, Mueller Bryon A, Nelson Steve, O'Connor Erin, Righi Giulia, Widge Alik S, Fiecas Mark, Benito Kristen
Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN, USA.
Masonic Institute for the Developing Brain, University of Minnesota, Minneapolis, MN, USA.
Trials. 2024 Dec 18;25(1):835. doi: 10.1186/s13063-024-08629-1.
Exposure with Response Prevention (ERP) is a first-line treatment for OCD, but even when combined with first-line medications it is insufficiently effective for approximately half of patients. Compulsivity in OCD is thought to arise from an imbalance of two distinct neural circuits associated with specific subregions of striatum. Targeted modulation of these circuits via key cortical nodes (dorsolateral prefrontal cortex [dlPFC] or presupplementary motor area [pSMA]) has the potential to improve ERP efficacy by decreasing compulsions during therapy.
The NExT (Neuromodulation + Exposure Therapy) trial is a two-phase, multisite early-stage randomized controlled trial designed to examine whether TMS augmentation of ERP alters activity in dlPFC and/or pSMA-associated circuitry and reduces compulsions during therapy in youth with OCD age 12-21 years. Phase 1 (N = 60) will compare two different active TMS regimens with sham: A. continuous theta burst stimulation (cTBS) to pSMA vs. B. intermittent theta burst stimulation (iTBS) to dlPFC. A priori "Go/No-Go" criteria will inform a decision to proceed to Phase 2 and the choice of TMS regimen. Phase 2 (N = 60) will compare the selected TMS regimen vs. sham in a new sample.
This trial is the first to test TMS augmentation of ERP in youth with OCD. Results will inform the potential of TMS to enhance ERP efficacy and enhance knowledge about mechanisms of change.
ClinicalTrials.gov NCT05931913. Registered prospectively on July 5, 2023.
暴露与反应阻止疗法（ERP）是强迫症的一线治疗方法，但即使与一线药物联合使用，仍有约一半的患者疗效不佳。强迫症中的强迫行为被认为是由与纹状体特定亚区域相关的两个不同神经回路失衡引起的。通过关键皮质节点（背外侧前额叶皮层[dlPFC]或辅助运动前区[pSMA]）对这些回路进行靶向调节，有可能通过减少治疗期间的强迫行为来提高ERP的疗效。
NExT（神经调节+暴露疗法）试验是一项两阶段、多中心的早期随机对照试验，旨在研究TMS增强ERP是否会改变12至21岁强迫症青少年的dlPFC和/或pSMA相关神经回路的活动，并减少治疗期间的强迫行为。第一阶段（N = 60）将比较两种不同的主动TMS方案与假刺激：A.对pSMA进行连续theta爆发刺激（cTBS）与B.对dlPFC进行间歇性theta爆发刺激（iTBS）。先验的“Go/No-Go”标准将为进入第二阶段的决定和TMS方案的选择提供依据。第二阶段（N = 60）将在一个新样本中比较所选的TMS方案与假刺激。
本试验是首次测试TMS增强ERP对患有强迫症的青少年的效果。结果将揭示TMS增强ERP疗效的潜力，并增进对变化机制的了解。
ClinicalTrials.gov NCT05931913。于2023年7月5日前瞻性注册。
