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临床试验/NCT03083483
NCT03083483已完成不适用

Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training

Duke University2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
71
试验地点
2
主要终点
Time to Completion

研究概览

简要总结

The purpose of this study is to test the influences of transcranial direct current stimulation (tDCS) on the acquisition of laparoscopic surgical skills. For this purpose, the investigator will compare variants of tDCS in the first of 2 experiments. The second arm of the trial will investigate gaze training in a similar study design. These questions will be evaluated using the validated Fundamentals of Laparoscopic Surgery (FLS) module 1, with the overall goal of developing a surgical training curriculum that achieves expert level skill in an expedited timeframe. This research provides a novel approach to general surgery training that has the potential to reduce the amount of time and repetitions required to achieve expert laparoscopic skills.

详细描述

Developing expert performance requires assessment of the thought processes underlying performance and continued refinement of skills in order to obtain automaticity and intuition. Therefore, developing expert surgical skill is a process likely to take longer than the length of residency, thereby diminishing the quality of care delivered to patients.

The proposed study will implement novel neuroscience techniques of transcranial direct current stimulation to determine if it has the capacity to accelerate technical surgical skill learning in order to achieve competency and expertise in an earlier timeframe. tDCS is a non-invasive brain stimulation technique that delivers constant, low current stimulation via electrodes placed on the scalp to modify cortical excitability in an area of interest. When applied to the motor cortex, promising data indicates that tDCS-induced changes lead to expedited recovery in stroke patients as well as enhanced learning in healthy individuals.

This technique has never been applied in the training of surgical residents making this project an innovative approach to enhance skill development.

Experiment 1: Determine if tDCS can accelerate the learning of laparoscopic skills.

In this experiment the investigators will compare behavioral learning curves from FLS modules 1 and 5 in three cohorts who undergo either active tDCS to the bilateral motor cortex (bilateral configuration), active tDCS to the supplementary motor cortex (SMA configuration), or sham tDCS (half in each configuration). This will be tested in groups of 20 participants who train for 40-minutes in each of 6 sessions that occur within 3 weeks. The investigators hypothesize that both active bilateral and SMA tDCS will lead to faster skill acquisition as measured by trials required to gain proficient completion scores (calculated as time plus errors), relative to sham.

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, Investigator)

盲法说明

For the tDCS portion of the protocol, the subject and investigator will be blinded to active vs sham. The configuration and order of FLS tasks will be known to both.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 years, healthy male and female
  • Negative urine pregnancy test for female participants
  • Willing and able to provide informed consent
  • Able to follow study procedures

排除标准

  • Indwelling metallic implants
  • Neurological or psychiatric medical history
  • Drug or alcohol abuse
  • Current or prior brain tumor
  • Current or prior seizures
  • Neuroactive medications
  • Current pregnancy
  • Damage, rash, or skin lesion in area of electrode placement

结局指标

主要结局

Time to Completion

时间窗: 7 days

Completion time for each repetition of Fundamentals of Laparoscopic Surgery (FLS) task 1 in post-test (1 single repetition of the task that was timed after all training was completed)

次要结局

  • Number of Tasks Completed(7 days)
  • Number of Errors(7 days)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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