Neurosurgical Skill Enhancement Using Transcranial Stimulation

NCT02987816 | Completed

• 1 other identifier: REB 15-2443
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurosurgery

Outcome Measures

Primary Outcomes (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.

  Baseline and immediately post-training

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Retention of primary and secondary outcomes measures

  6 weeks following training

Study Arms (2)

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.

Device: Sham tDCS

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.

Device: Anodal tDCS

Interventions

Sham tDCS DEVICE

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.

Also known as: Sham transcranial direct current stimulation

Sham tDCS

Anodal tDCS DEVICE

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.

Also known as: Anodal transcranial direct current stimulation

Anodal tDCS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical student
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Related Publications (4)

• 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.

  PMID: 23521960 BACKGROUND

• 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.

  PMID: 10990547 BACKGROUND

• 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.

  PMID: 21968548 BACKGROUND

• 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.

  PMID: 19164589 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate (Neurosciences)

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share