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Clinical Trials/NCT02987816
NCT02987816CompletedNot Applicable

Learning Enhancement Using Transcranial Stimulation, Leading Expertise, Acquisition and Retention of Neurosurgical Skills

University of Calgary0 sites22 target enrollmentStarted: November 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Primary Endpoint
Change in % tumor resected

Study Overview

Brief Summary

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 neurosurgical skill. The investigators propose a double blind, sham-controlled randomized trial applying tDCS during evidence-based SBTT of medical students, to determine if brain stimulation can enhance training skill acquisition and retention. Even a modest enhancement carries the potential to transform medicosurgical skills training.

Detailed Description

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 neurosurgical 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 neurosurgical 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 over 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Medical student
  • Informed consent

Exclusion Criteria

  • 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

Arms & Interventions

Sham tDCS

Sham Comparator

Sham tDCS. 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Intervention: Sham tDCS (Device)

Anodal tDCS

Experimental

Anodal tDCS. 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.

Intervention: Anodal tDCS (Device)

Outcomes

Primary Outcomes

Change in % tumor resected

Time Frame: Baseline and immediately post-training

A "baseline" trial will be performed, followed by 8 consecutive "training" trials (approximately 30 minutes of training), immediately followed by a "post-training" trial.

Secondary Outcomes

  • Change in volume of healthy tissue resected(Baseline and immediately post-training)
  • Change in time of excessive forces on tumor(Baseline and immediately post-training)
  • Change in time of excessive forces on healthy tissue(Baseline and immediately post-training)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Patrick Ciechanski

PhD Candidate (Neurosciences)

University of Calgary

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