Performance EnhancementNCT04155333
Effects of Non-Invasive Brain Stimulation on Soldiers' Cognitive and Functional Performance
A study testing Transcranial direct current stimulation in people with Performance Enhancement, run by United States Army Aeromedical Research Laboratory at 1 site in United States.
Trial summary
Non-invasive brain stimulation has been shown to alter performance in both clinical and healthy populations on cognitive tasks. While the performance alterations have generally been shown to result in enhancement, mixed results remain in the literature. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Performance Enhancement
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 30 Sep 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be 18 (if active duty), 19 (if non-active duty) up to 40 years old.
- Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and screening by study physician
- Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by actigraphy data and self-report.
- Must have refrained from consumption of caffeine, 16 hours, nicotine, 2 hours, and alcohol, 24 hours, prior to the study, assessed by self-report.
Who cannot join
- The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician:
- Haven taken any medications which induce drowsiness, such as over-the-counter antihistamines within 24 hours of participation in the study. Any self-medication will be assessed through self-report
- No current medical conditions or medications affecting cognitive function or attention.
- Any history of any attention deficit condition requiring medication.
- Any history of psychological/psychiatric disorder.
- Any history of seizures, migraines, or neurological disorders.
Show all 12Show fewer
- History of a head injury involving loss of consciousness.
- Any metal implanted within the head (e.g., shrapnel, surgical clips) or any implanted devices (e.g., cardiac pacemaker, brain stimulator, hydrocephalic shunt).
- Skin condition on the scalp, such as psoriasis or eczema, or wounds on the head.
- Currently receiving hormonal therapy treatments, other than birth control or as determined by physicians.
- Potential for caffeine withdrawal symptoms that will impede cognitive testing.
- Females with a known pregnancy, who test positively for pregnancy, or refuse the test will be excluded, given the lack of available research regarding the effects of tDCS during pregnancy. Known pregnancy will be assessed during screening, females without a known pregnancy will be requested to provide a urine sample during the screening procedures to ensure the absence of pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.S. Army Aeromedical Research Laboratory
Fort Rucker, Alabama, 36362
About this study
Non-invasive brain stimulation has been shown to alter performance in both clinical and healthy populations on cognitive tasks. While the performance alterations have generally been shown to result in enhancement, mixed results remain in the literature. Much of the mixed results within the literature have been attributed to the use of different stimulation parameters, targeting of different brain areas, and using a variety of performance measures or assessing different constructs. However, non-invasive brain stimulation is a desirable method for enhancing Soldier performance given the ease of administration and minimal side effects as compared to other forms of performance enhancement (e.g., pharmaceuticals, caffeine). The objective of the current study is to evaluate the effects of non-invasive brain stimulation to the left dorsolateral prefrontal cortex in enhancing Soldier cognitive skills and performance on military tasks. A double blind within-subjects design will be used with healthy, rested Soldiers who will receive non-invasive brain stimulation and perform basic cognitive and operationally relevant tasks.
- Conditions
- Performance Enhancement
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that stimulates the brain through the application of a low-intensity electrical current, typically ranging from 1 to 2 milliamps (mA), via electrodes placed on an individual's scalp. During the active stimulation sessions, 2 mA of stimulation will be applied for 30 minutes. During the sham stimulation session, 2 mA of stimulation will be applied over the course of 90 sec, the electrodes will remain in place for the 30 minute duration.
| Study group | Role | What they receive |
|---|---|---|
| Active anodal stimulation | Experimental | active anodal stimulation at F3, cathode placed on contralateral bicep Receives: Device: Transcranial direct current stimulation |
| Active cathodal stimulation | Experimental | active cathodal stimulation at F3, anode placed on contralateral bicep Receives: Device: Transcranial direct current stimulation |
| Sham stimulation | Sham comparator | sham stimulation that will be counterbalanced between subjects such that half will receive sham stimulation configured as condition 1 (anode F3, cathode bicep) and half will receive condition 2 (cathode F3, anode bicep) Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Military task performance
Patrol exertion multitask
Measured: Folllowing stimulation; task lasts approximately 20 min
Military task performance
Target acquisition
Measured: Folllowing stimulation; task lasts approximately 40 min
Cognitive function - Selective Attention
Stroop test
Measured: Approximately 3 minutes during stimulation
Cognitive function - Multitasking/Working Memory
Dual n-back
Measured: Approximately 5 minutes during stimulation
Cognitive function - Working Memory
Digit span task
Measured: Approximately 2 minutes during stimulation
Cognitive function - Sustained attention
Rapid Visual Information Processing Task
Measured: Approximately 7 minutes during stimulation
Cognitive function - Executive function
Shifting Attention Task: Digit symbol substitution task
Measured: Approximately 2 minutes during stimulation
Secondary outcomes (3)
Cognitive function - Impulsivity/Motor Control
Stop signal task - response inhibition
Measured: Approximately 3 minutes after stimulation
Cognitive function - Risk Taking/ Decision Making
Delayed Discounting Task
Measured: Approximately 1 minute after stimulation
Cognitive function - Cognitive Flexibility
Uses Task
Measured: Approximately 5 minutes after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start12 Dec 2019
- Primary completion1 Jun 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Performance EnhancementStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A double-blind, randomized, sham-controlled, within-subjects design
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Aeromedical Research Laboratory
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Katie Feltman, PhD, Principal investigator, US Army Aeromedical Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155333
- Sponsor's protocol ID
- USAARL 2018-002; M-10782
- Status last verified
- Jan 2022
- First submitted
- 5 Nov 2019
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-Invasive Brain Stimulation on Soldiers' Cognitive and Functional Performance
- ClinicalTrials.gov ID
- NCT04155333
- Acronym / sponsor ID
- USAARL 2018-002; M-10782
- Conditions
- Performance Enhancement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- United States Army Aeromedical Research LaboratoryUS federal agency
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-invasive brain stimulation has been shown to alter performance in both clinical and healthy populations on cognitive tasks. While the performance alterations have generally been shown to result in enhancement, mixed results remain in the literature. Much of the mixed results within the literature have been attributed to the use of different stimulation parameters, targeting of different brain areas, and using a variety of performance measures or assessing different constructs. However, non-invasive brain stimulation is a desirable method for enhancing Soldier performance given the ease of administration and minimal side effects as compared to other forms of performance enhancement (e.g., pharmaceuticals, caffeine). The objective of the current study is to evaluate the effects of non-invasive brain stimulation to the left dorsolateral prefrontal cortex in enhancing Soldier cognitive skills and performance on military tasks. A double blind within-subjects design will be used with healthy, rested Soldiers who will receive non-invasive brain stimulation and perform basic cognitive and operationally relevant tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- A double-blind, randomized, sham-controlled, within-subjects design
| Arm | Type | Receives |
|---|---|---|
| Active anodal stimulation | Experimental | Device: Transcranial direct current stimulationactive anodal stimulation at F3, cathode placed on contralateral bicep |
| Active cathodal stimulation | Experimental | Device: Transcranial direct current stimulationactive cathodal stimulation at F3, anode placed on contralateral bicep |
| Sham stimulation | Sham comparator | Device: Transcranial direct current stimulationsham stimulation that will be counterbalanced between subjects such that half will receive sham stimulation configured as condition 1 (anode F3, cathode bicep) and half will receive condition 2 (cathode F3, anode bicep) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Must be 18 (if active duty), 19 (if non-active duty) up to 40 years old.
- Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and screening by study physician
- Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by actigraphy data and self-report.
- Must have refrained from consumption of caffeine, 16 hours, nicotine, 2 hours, and alcohol, 24 hours, prior to the study, assessed by self-report.
Key exclusion criteria (12 listed)
- The following medically-related exclusionary criteria will be used, as assessed and verified by the study physician:
- Females with a known pregnancy, who test positively for pregnancy, or refuse the test will be excluded, given the lack of available research regarding the effects of tDCS during pregnancy. Known pregnancy will be assessed during screening, females without a known pregnancy will be requested to provide a urine sample during the screening procedures to ensure the absence of pregnancy.
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 stimulationTranscranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that stimulates the brain through the application of a low-intensity electrical current, typically ranging from 1 to 2 milliamps (mA), via electrodes placed on an individual's scalp. During the active stimulation sessions, 2 mA of stimulation will be applied for 30 minutes. During the sham stimulation session, 2 mA of stimulation will be applied over the course of 90 sec, the electrodes will remain in place for the 30 minute duration. | Device | Active anodal stimulation, Active cathodal stimulation, Sham stimulation |
Primary outcome
Military task performance
Time frame: Folllowing stimulation; task lasts approximately 20 min
Patrol exertion multitask
Military task performance
Time frame: Folllowing stimulation; task lasts approximately 40 min
Target acquisition
Cognitive function - Selective Attention
Time frame: Approximately 3 minutes during stimulation
Stroop test
Cognitive function - Multitasking/Working Memory
Time frame: Approximately 5 minutes during stimulation
Dual n-back
Cognitive function - Working Memory
Time frame: Approximately 2 minutes during stimulation
Digit span task
Cognitive function - Sustained attention
Time frame: Approximately 7 minutes during stimulation
Rapid Visual Information Processing Task
Cognitive function - Executive function
Time frame: Approximately 2 minutes during stimulation
Shifting Attention Task: Digit symbol substitution task
3 secondary outcomes
Cognitive function - Impulsivity/Motor Control
Time frame: Approximately 3 minutes after stimulation
Cognitive function - Risk Taking/ Decision Making
Time frame: Approximately 1 minute after stimulation
Cognitive function - Cognitive Flexibility
Time frame: Approximately 5 minutes after stimulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- 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.
Katie Feltman, PhD principal investigator
US Army Aeromedical Research Laboratory
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 in people with Performance Enhancement, run by United States Army Aeromedical Research Laboratory 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 12 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 25 Jan 2022. 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?
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?
Military task performance (time frame: Folllowing stimulation; task lasts approximately 20 min). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2022.