Gholamali Nezhad Fatemeh, Tassone Vanessa K, Demchenko Ilya, Chen Jia Xi Mary, Iwasa Stephanie N, Martin Josh, Desai Naaz, Naguib Hani E, Popovic Milos R, Bhat Venkat
Interventional Psychiatry Program, St. Michael's Hospital, Unity Health Toronto, 193 Yonge Street 6 - 013, Toronto, ON, M5B 1M4, Canada.
Institute of Medical Science, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Pilot Feasibility Stud. 2025 May 3;11(1):60. doi: 10.1186/s40814-025-01642-4.
One-third of patients with major depressive disorder (MDD) will not achieve a clinically meaningful response to available conventional treatments. More effective neurostimulation treatments are difficult to access and are associated with high hospital delivery costs. Patients would benefit from more efficacious and well-tolerated home-based neurostimulation treatments, which could be self-administered at a frequency required to treat MDD, maintain response, and reduce relapse. A potential novel intervention for MDD is bilateral functional electrical stimulation (FES) of the facial muscles. The portable FES stimulator delivers electrical current to excitable tissues and is suitable for home-based use. Based on the preliminary work demonstrating the feasibility of FES for MDD, the proposed study will develop a viable prototype for a "take-home" FES device and perform a proof-of-concept feasibility trial for participants with MDD.
This is a single-site, pilot, double-blind, randomized, sham-controlled clinical trial, where 20 participants will receive 20 sessions of FES over 4 weeks. The trial will evaluate the feasibility, tolerability, and safety of home-based FES for MDD. We will also collect data on the preliminary therapeutic effects of FES on depressive symptoms and associated anxiety, quality of life, and sleep. Eligible participants will have three on-site visits including one mask development visit, one mask delivery visit, and one follow-up visit at the end of the study. They will also attend 25 online visits including a screening visit, a baseline visit, 20 days of FES treatment (sham or active), and three post-stimulation follow-up visits.
Data obtained from this trial will be used to optimize the home-based FES prototype and design a follow-up, multi-site, large-scale randomized control trial to assess the effectiveness of take-home FES. The existing evidence suggests that FES of the facial muscles can reduce MDD symptoms by enhancing positive facial feedback and altering the interoceptive bias associated with MDD, but its exact mechanism of action is still under debate. Additional trials with neuroimaging outcomes are needed to elucidate the mechanism of action of FES and the corresponding changes in the central nervous system.
This trial has been registered at the National Library of Medicine, National Center for Biotechnology Information (ClinicalTrials.gov: NCT06261177 . Registered on January 4, 2024).
三分之一的重度抑郁症（MDD）患者对现有的传统治疗方法无法产生具有临床意义的反应。更有效的神经刺激治疗难以获得，且与高昂的住院费用相关。患者将受益于更有效且耐受性良好的家庭式神经刺激治疗，这种治疗可以按照治疗MDD所需的频率自行进行，维持疗效并减少复发。一种针对MDD的潜在新型干预措施是对面部肌肉进行双侧功能性电刺激（FES）。便携式FES刺激器可将电流输送到可兴奋组织，适合在家中使用。基于证明FES治疗MDD可行性的初步工作，拟开展的研究将开发一种可行的“带回家使用”的FES设备原型，并对MDD患者进行概念验证可行性试验。
这是一项单中心、试点、双盲、随机、假对照临床试验，20名参与者将在4周内接受20次FES治疗。该试验将评估家庭式FES治疗MDD的可行性、耐受性和安全性。我们还将收集关于FES对抑郁症状及相关焦虑、生活质量和睡眠的初步治疗效果的数据。符合条件的参与者将进行三次现场访视，包括一次面罩制作访视、一次面罩交付访视以及研究结束时的一次随访访视。他们还将参加25次在线访视，包括一次筛查访视、一次基线访视、20天的FES治疗（假刺激或真刺激）以及三次刺激后随访访视。
从该试验中获得的数据将用于优化家庭式FES原型，并设计一项后续的多中心、大规模随机对照试验，以评估带回家使用的FES的有效性。现有证据表明，面部肌肉的FES可通过增强积极的面部反馈并改变与MDD相关的内感受偏差来减轻MDD症状，但其确切作用机制仍存在争议。需要更多具有神经影像学结果的试验来阐明FES的作用机制以及中枢神经系统的相应变化。
该试验已在美国国立医学图书馆国家生物技术信息中心注册（ClinicalTrials.gov：NCT06261177。于2024年
