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NeurosurgeryLETS-LEARNNCT02987816

Neurosurgical Skill Enhancement Using Transcranial Stimulation

A study testing Anodal tDCS in people with Neurosurgery, run by University of Calgary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Neurosurgery
What is being tested?
Anodal tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
No sites listed yet
Study dates
Nov 2016to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Medical student
  • Informed consent

Who cannot join

  • 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
  • Pregnant

About this study

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

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.

Read the 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.

Participants: Medical students (years 1-3) from the Cumming School of Medicine (University of Calgary) will be recruited. To ensure comparable baseline skills, trainees will be excluded if they have undergone formal neurosurgical training in the past 3 months.

Sample size calculations are based on the performance measures for the percentage of virtual tumor resected, determined through pilot studies. Based on 20% more tumor being resected at post-training, power of 90% and type-1 error of 0.05, the investigators estimate a sample size of a minimum of 24 participants (n=12 per stimulation condition).

Study Design: A short questionnaire will be completed to determine demographic characteristics, including: gender, age, level of training, how many times participants have performed on a virtual surgical simulator, how often participants play video games, and how often participants play a musical instrument.

Participants will be recruited at the Project NeuroArm Laboratory (University of Calgary) and be oriented to the workspace. Participants will complete virtual tumor resections on a NeuroTouch (National Research Council of Canada) surgical simulator. Participants will view a standardized training video, created by an expert in neurosurgery, demonstrating a virtual tumor resection using the simulator. Participant will have 3 minutes to resect a virtual tumor, avoiding resection of healthy tissue. Recorded outcome metrics will include: % tumor resected, volume of healthy tissue resected, time of excessive force on tumor and time of excessive force on healthy tissue.

Participants will perform one resection at baseline, establishing baseline skill. Participants will be randomized to receive sham or active tDCS by blinding selecting a code from the envelope, corresponding to a particular stimulation condition. Participants will perform eight training repetitions, taking approximately 30 minutes. Following approximately 30 minutes of training (eight training repetitions) the tDCS electrodes will be removed, and a final resection will be performed. Six weeks following the training the participants will return to assess retention of skill, performing a single resection. Emerging evidence suggests that a significant decay in surgical skill is present six weeks following training.

Data Analysis: Independent samples t-test will evaluate difference in outcome metrics at post-training between stimulation conditions. Two-way repeated-measures ANOVA for factors "stimulation type" and "training block" will explore the interaction between tDCS and training for each outcome metric. Retention of skill will be assessed using a paired t-test for each stimulation group.

Conditions
Neurosurgery
Being tested
Sham tDCS, Anodal tDCS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sham tDCSDevice

    Also called Sham transcranial direct current stimulation

    NeuroConn Direct-Current Stimulator. 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.

  • Anodal tDCSDevice

    Also called Anodal transcranial direct current stimulation

    NeuroConn Direct-Current Stimulator. Sham 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.

Study groups in NCT02987816
Study groupRoleWhat they receive
Sham tDCSSham comparatorSham 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.
Receives: Device: Sham tDCS
Anodal tDCSExperimentalAnodal 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.
Receives: Device: Anodal tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in % tumor resected

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

    Measured: Baseline and immediately post-training

Secondary outcomes (3)
  1. Change in volume of healthy tissue resected

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

    Measured: Baseline and immediately post-training

  2. Change in time of excessive forces on tumor

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

    Measured: Baseline and immediately post-training

  3. Change in time of excessive forces on healthy tissue

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

    Measured: Baseline and immediately post-training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987816
Sponsor's protocol ID
REB 15-2443
Acronym
LETS-LEARN
Status last verified
Nov 2017
First submitted
25 Nov 2016
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Coleman JJ, Esposito TJ, Rozycki GS, Feliciano DV. Early subspecialization and perceived competence in surgical training: are residents ready? J Am Coll Surg. 2013 Apr;216(4):764-71; discussion 771-3. doi: 10.1016/j.jamcollsurg.2012.12.045.

    PubMed 23521960
  • Nitsche MA, Paulus W. Excitability changes induced in the human motor cortex by weak transcranial direct current stimulation. J Physiol. 2000 Sep 15;527 Pt 3(Pt 3):633-9. doi: 10.1111/j.1469-7793.2000.t01-1-00633.x.

    PubMed 10990547
  • Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.

    PubMed 21968548
  • Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.

    PubMed 19164589

Questions about this trial

What is this clinical trial studying?

A study testing Anodal tDCS in people with Neurosurgery, run by University of Calgary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in % tumor resected (time frame: Baseline and immediately post-training). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02987816, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.

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