Healthy VolunteersNCT03083483
Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
A study testing transcranial direct current stimulation (tDCS) in people with Healthy Volunteers, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
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.
The investigators hypothesize that both bilateral and vertex tDCS will lead to faster skill acquisition, with bilateral greater than vertex as measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without active tDCS.
- Conditions
- Healthy Volunteers
- Being tested
- transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulation (tDCS)Device
Also called Soterix
tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral M1, active tDCS | Experimental | Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side. Receives: Device: transcranial direct current stimulation (tDCS) |
| SMA, active tDCS | Experimental | Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex. Receives: Device: transcranial direct current stimulation (tDCS) |
| sham tDCS | Sham comparator | Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation. Half of these subjects will be placed in the SMA configuration and the other half in the bilateral M1 electrode configuration. Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Completion
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)
Measured: 7 days
Secondary outcomes (2)
Number of Tasks Completed
The number of completed tasks will be calculated during retrospective review of recorded video through study completion. The six training sessions for data collection will be completed within a 7-day span.
Measured: 7 days
Number of Errors
The number of errors (as defined by FLS) during completion of tasks will be recorded and transitioned into a time addition. This will be collected for every repetition performed during the 6 separate training sessions within a 7-day period. These errors will be defined and retrospective review of recorded video through study completion.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Apr 2017
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- Subjects are randomized into SMA or bilateral M1 tDCS configurations. They are further randomized into active or sham tDCS.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Morgan L Cox, MD, Principal investigator, Duke UniversityGreg Appelbaum, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083483
- Sponsor's protocol ID
- Pro00078782
- Status last verified
- Jan 2020
- First submitted
- 14 Mar 2017
- Last updated
- 6 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cox ML, Deng ZD, Palmer H, Watts A, Beynel L, Young JR, Lisanby SH, Migaly J, Appelbaum LG. Utilizing transcranial direct current stimulation to enhance laparoscopic technical skills training: A randomized controlled trial. Brain Stimul. 2020 May-Jun;13(3):863-872. doi: 10.1016/j.brs.2020.03.009. Epub 2020 Mar 19.
PubMed 32289719
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Transcranial Direct Current Stimulation to Enhance Laparoscopic Technical Skills Training
- ClinicalTrials.gov ID
- NCT03083483
- Acronym / sponsor ID
- Pro00078782
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators hypothesize that both bilateral and vertex tDCS will lead to faster skill acquisition, with bilateral greater than vertex as measured by trials required to gain proficient module completion scores, relative to the group of participants who practice without active tDCS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Subjects are randomized into SMA or bilateral M1 tDCS configurations. They are further randomized into active or sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| Bilateral M1, active tDCS | Experimental | Device: transcranial direct current stimulation (tDCS)Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the bilateral M1 areas of the brain by measurement of 20% length of periauricular distance left and right of the vertex. The anode was placed on the left side and the cathode was placed on the right side. |
| SMA, active tDCS | Experimental | Device: transcranial direct current stimulation (tDCS)Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants randomized to this cohort had tdcs applied over the supplementary motor area. The cathode was placed 10% of nasion-inion distance above the nasion and 15% of nasion-inion distance anterior to the vertex. |
| sham tDCS | Sham comparator | Device: transcranial direct current stimulation (tDCS)Participants will complete 6 sessions of the FLS peg transfer task over a 7-day time span. Participants in this group were either randomized into either Bilateral or SMA configurations using the same measurements, but did not receive active stimulation. Half of these subjects will be placed in the SMA configuration and the other half in the bilateral M1 electrode configuration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Indwelling metallic implants
- Neurological or psychiatric medical history
- Drug or alcohol abuse
- Current or prior brain tumor
- Current or prior seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulation (tDCS)Also: SoterixtDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks. | Device | Bilateral M1, active tDCS, SMA, active tDCS, sham tDCS |
Primary outcome
Time to Completion
Time frame: 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)
2 secondary outcomes
Number of Tasks Completed
Time frame: 7 days
Number of Errors
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32289719Cox ML, Deng ZD, Palmer H, Watts A, Beynel L, Young JR, Lisanby SH, Migaly J, Appelbaum LG. Utilizing transcranial direct current stimulation to enhance laparoscopic technical skills training: A randomized controlled trial. Brain Stimul. 2020 May-Jun;13(3):863-872. doi: 10.1016/j.brs.2020.03.009. Epub 2020 Mar 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morgan L Cox, MD principal investigator
Duke University
Greg Appelbaum, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) in people with Healthy Volunteers, run by Duke University at 1 site in United States.
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 4 inclusion and 8 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Completion (time frame: 7 days). 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 NCT03083483, which also lists 1 linked publication.
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 6 Jan 2020.