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临床试验/NCT02756052
NCT02756052已完成不适用

Enhancing Laparoscopic Skill Acquisition and Retention With Transcranial Direct-current Stimulation

University of Calgary2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change in Fundamentals of Laparoscopic Surgery pattern cutting task total score

研究概览

简要总结

Recent changes in medical training environments and restrictive work-hour regulations have greatly impacted trainees, limiting the number of opportunities to gain proficiency in procedural skills. Reports suggest that medical residents lack confidence in their ability to perform certain medical procedures, and program directors often do not believe their residents can operate independently in major procedures. Simulator based task training (SBTT) has provided a safe and ethically appropriate method of skill acquisition but training opportunities remain limited. Methods to enhance motor learning during these training opportunities have not been described. Transcranial direct-current stimulation (tDCS) is an emerging form of non-invasive brain stimulation that has been shown to improve motor learning. tDCS has been shown to enhance increasingly complex skill acquisition. The investigators propose to examine if tDCS can improve the acquisition and retention of laparoscopic surgical skill. The investigators propose a double blind, sham-controlled randomized trial applying tDCS during evidence-based SBTT of medical students and surgical residents, to determine if brain stimulation can enhance training effects and long-term skill acquisition. Even a modest enhancement carries the potential to transform medicosurgical skills training.

详细描述

Rationale: Recent changes in medical training environments have resulted in many trainees lacking sufficient opportunity to acquire specific skills necessary for their specialty. New methods to enhance the acquisition and retention of medical and surgical skills are required to ensure the quality of the future physician workforce. Transcranial direct-current stimulation (tDCS) is an emerging method of non-invasive brain stimulation that has been show to safely enhance motor learning in adults and children. Even a modest enhancement of acquisition and retention of medical-surgical skill with tDCS carries the potential to accelerate skill training for health care providers, thereby contributing to greater training efficiency and improved patient outcomes.

Objectives: The objective of this study is to assess whether tDCS can enhance the acquisition and retention of laparoscopic surgical ability.

Ethics:This study has been approval by the University of Calgary Research Ethics Board

Design: Randomized, double blind, sham-controlled trial to evaluate the ability of tDCS to enhance learning and retention of laparoscopic skills.

Transcranial Direct-Current Stimulation: The tDCS methods used are based on best-available evidence and practices, and will be applied in a standardized fashion by experienced investigators. Anodal tDCS will be delivered through saline-soaked sponge electrodes using a NeuroConn Direct-Current Stimulator (NeuroConn, Ilmenau, Germany). The anode will be centered 2cm posterior to the left primary motor cortex (localized using the 10-20 EEG System), with the cathode over the contralateral supraorbital area. Both anodal and sham tDCS groups will have the current ramped up to 1milliamp over 30 seconds. In the anodal tDCS group, the current will be held for 20 minutes. In the sham tDCS condition, the current will be held for only 60 seconds (no changes in cortical excitability) followed by a 30 second ramp-down.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Medical student or general surgery residents
  • Informed consent

排除标准

  • Diagnosis of a developmental, neurological or neuropsychiatric disorder
  • Taking neuropsychotropic medication
  • Has an irremovable implanted metal object in the head
  • Has a pacemaker or other implanted electrical device

结局指标

主要结局

Change in Fundamentals of Laparoscopic Surgery pattern cutting task total score

时间窗: Baseline and Immediately Post-Training

A "baseline trial" will be performed, followed by 8 consecutive "training trials", immediately followed by a "post-training trial". A total score is calculated by subtracting the error score from the time score. A time score will be calculated by subtracting the completion time in seconds from the task cut-off time of 300 seconds. An error score will be calculated as the percentage area deviation of cutting a perfect circle.

Change in Fundamentals of Laparoscopic Surgery peg transfer task total score

时间窗: Baseline and Immediately Post-Training

A "baseline trial" will be performed, followed by 8 consecutive "training trials", immediately followed by a "post-training trial". A total score is calculated by subtracting the error score from the time score. A time score will be calculated by subtracting the completion time in seconds from the task cut-off time of 300 seconds. An error score will be calculated as the percentage of pegs that could not be transferred due to being dropped outside of the field of view (i.e. 1 of 6 pegs lost = 17 second penalty).

次要结局

  • Retention of Fundamentals of Laparoscopic Surgery peg transfer task total score(6 Weeks following Training)
  • Retention of Fundamentals of Laparoscopic Surgery pattern cutting task total score(6 Weeks following Training)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick Ciechanski

PhD Candidate (Neurosciences)

University of Calgary

研究点 (2)

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