PDF(Pubmed)
Abstract：
BACKGROUND: Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert therapeutic effects in patients with major depressive disorder (MDD). Due to its beneficial safety profile, its easy mode of application, and its cost-effectiveness, tDCS has recently been proposed for treatment at home. This would offer new chances for regionally widespread and long-term application. However, tDCS at home must meet the new methodological challenges of handling and adherence. At the same time, data from randomized controlled trials (RCT) investigating this mode of application are still lacking. In this pilot RCT, we therefore investigate the feasibility, safety, and effectiveness of a new antidepressant tDCS application set-up.
METHODS: The HomeDC trial will be conducted as a double-blind, placebo-controlled, parallel-group design trial. Thirty-two study participants with MDD will be randomly assigned to active or sham tDCS groups. Participants will self-administer prefrontal tDCS for 6 weeks. Active tDCS will be conducted with anode over F3, cathode over F4, for 5 sessions/week, with a duration of 30 min/day, and 2 mA stimulation intensity. Sham tDCS, conversely, follows an identical protocol in regard to electrode montage and timing, but with no electric stimulation between the ramp-in and ramp-out periods. Both conditions will be administered either as a monotherapy or an adjunctive treatment to a stable dose of antidepressant medication. Adjunctive magnetic resonance imaging (MRI) and electric field (E-field) modelling will be conducted at baseline. Primary outcome is feasibility based on successfully completed stimulations and drop-out rates. The intervention is considered feasible when 20 out of 30 sessions have been fully conducted by at least 75% of the participants. Effectiveness and safety will be assessed as secondary outcomes.
CONCLUSIONS: In the HomeDC trial, the technical requirements for a placebo-controlled tDCS study in a home-based treatment setting have been established. The trial addresses the crucial points of the home-based tDCS treatment approach: uniform electrode positioning, frequent monitoring of stimulation parameters, adherence, and ensuring an appropriate home treatment environment. This study will further identify constraints and drawbacks of this novel mode of treatment.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021.
METHODS: The HomeDC trial will be conducted as a double-blind, placebo-controlled, parallel-group design trial. Thirty-two study participants with MDD will be randomly assigned to active or sham tDCS groups. Participants will self-administer prefrontal tDCS for 6 weeks. Active tDCS will be conducted with anode over F3, cathode over F4, for 5 sessions/week, with a duration of 30 min/day, and 2 mA stimulation intensity. Sham tDCS, conversely, follows an identical protocol in regard to electrode montage and timing, but with no electric stimulation between the ramp-in and ramp-out periods. Both conditions will be administered either as a monotherapy or an adjunctive treatment to a stable dose of antidepressant medication. Adjunctive magnetic resonance imaging (MRI) and electric field (E-field) modelling will be conducted at baseline. Primary outcome is feasibility based on successfully completed stimulations and drop-out rates. The intervention is considered feasible when 20 out of 30 sessions have been fully conducted by at least 75% of the participants. Effectiveness and safety will be assessed as secondary outcomes.
CONCLUSIONS: In the HomeDC trial, the technical requirements for a placebo-controlled tDCS study in a home-based treatment setting have been established. The trial addresses the crucial points of the home-based tDCS treatment approach: uniform electrode positioning, frequent monitoring of stimulation parameters, adherence, and ensuring an appropriate home treatment environment. This study will further identify constraints and drawbacks of this novel mode of treatment.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021.
摘要：
背景：据报道，经颅直流电刺激前额叶皮质区域（tDCS）对重度抑郁症（MDD）患者具有治疗作用。由于其有利的安全性，其简单的应用模式，以及它的成本效益，最近提出了在家中治疗tDCS。这将为区域广泛和长期应用提供新的机会。然而,国内的tDCS必须应对处理和遵守的新方法挑战。同时,研究这种应用模式的随机对照试验(RCT)的数据仍然缺乏.在这个飞行员RCT中，因此，我们研究可行性，安全,以及新的抗抑郁药tDCS应用设置的有效性。
方法：HomeDC试验将以双盲方式进行，安慰剂对照,平行组设计试验。32名患有MDD的研究参与者将被随机分配到活动或假tDCS组。参与者将自我管理前额叶tDCS6周。有源tDCS将在阳极上F3，阴极上F4进行，每周5次，持续时间为30分钟/天，和2mA刺激强度。假tDCS，相反,遵循关于电极蒙太奇和定时的相同协议，但是在爬坡和爬坡之间没有电刺激。两种情况将作为单一疗法或辅助治疗给予稳定剂量的抗抑郁药物。辅助磁共振成像（MRI）和电场（E场）建模将在基线进行。主要结果是基于成功完成的刺激和辍学率的可行性。当至少75％的参与者充分进行了30次会议中的20次时，该干预措施被认为是可行的。有效性和安全性将作为次要结果进行评估。
结论：在HomeDC试验中，在以家庭为基础的治疗环境中,安慰剂对照的tDCS研究的技术要求已经确立.该试验解决了基于家庭的tDCS治疗方法的关键点：均匀电极定位，频繁监测刺激参数，坚持,并确保适当的家庭治疗环境。这项研究将进一步确定这种新型治疗方式的制约因素和缺点。
背景：www.
结果：政府。
背景：NCT05172505。注册日期：2021年12月13日。
方法：HomeDC试验将以双盲方式进行，安慰剂对照,平行组设计试验。32名患有MDD的研究参与者将被随机分配到活动或假tDCS组。参与者将自我管理前额叶tDCS6周。有源tDCS将在阳极上F3，阴极上F4进行，每周5次，持续时间为30分钟/天，和2mA刺激强度。假tDCS，相反,遵循关于电极蒙太奇和定时的相同协议，但是在爬坡和爬坡之间没有电刺激。两种情况将作为单一疗法或辅助治疗给予稳定剂量的抗抑郁药物。辅助磁共振成像（MRI）和电场（E场）建模将在基线进行。主要结果是基于成功完成的刺激和辍学率的可行性。当至少75％的参与者充分进行了30次会议中的20次时，该干预措施被认为是可行的。有效性和安全性将作为次要结果进行评估。
结论：在HomeDC试验中，在以家庭为基础的治疗环境中,安慰剂对照的tDCS研究的技术要求已经确立.该试验解决了基于家庭的tDCS治疗方法的关键点：均匀电极定位，频繁监测刺激参数，坚持,并确保适当的家庭治疗环境。这项研究将进一步确定这种新型治疗方式的制约因素和缺点。
背景：www.
结果：政府。
背景：NCT05172505。注册日期：2021年12月13日。
