HealthyBRAIN-STIMNCT06995560
Effects of Transcranial Electrical Stimulation on Task Performance in Healthy Adults
A study testing Active Transcranial Electrical Stimulation in people with Healthy and Brain Stimulation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The objective of this randomized, double-blind, sham-controlled, crossover study is to evaluate the effects of transcranial electrical stimulation (tES) on complex cognitive task performance in healthy adult volunteers. The primary questions this study aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Brain Stimulation, Transcranial Direct Current Stimulation (tDCS)
- What is being tested?
- Active Transcranial Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2022to 31 Oct 2024
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25 to 55 years
- Master's or Doctorate degree, or equivalent relevant experience
- No history of head injury or neurological or psychiatric disorders
- No history of cardiac disease
- No metal implants in the head
- No implanted electronic devices
- Not taking medication affecting neural or cardiovascular function
- Able to provide written, dated informed consent
Who cannot join
- Smoking within the past year
- Current illegal drug use
- Alcohol abuse
- Pregnancy (confirmed by urine test)
- Participation in another brain stimulation protocol within the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Research Institute
Charlestown, Massachusetts, 02129
About this study
Official title: Preliminary Investigations of Transcranial Electrical Stimulation Effects on Neurophysiology and Behavior
The objective of this randomized, double-blind, sham-controlled, crossover study is to evaluate the effects of transcranial electrical stimulation (tES) on complex cognitive task performance in healthy adult volunteers.
The primary questions this study aims to answer are:
Read more
- Does tES improve task performance, including speed, accuracy, and overall success, during a computerized track-and-capture task?
- Do different stimulation targets produce differential effects on performance?
- Are there short-term post-stimulation effects on task performance (up to 48 hours)?
Participants will:
- Complete two testing sessions under either active or sham stimulation conditions.
- Perform a complex operational task involving dual-hand controllers while undergoing tES or sham stimulation, and immediately after.
- Return for follow-up task performance assessments at 24 and 48 hours post-stimulation to evaluate after-effects.
Read the detailed description
Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique that delivers low-intensity electrical currents (e.g., <2 mA) through scalp electrodes to modulate brain activity. Numerous studies have shown that tES can enhance cognitive functions such as learning, memory, attention, and decision-making in healthy individuals, as well as provide therapeutic benefits in psychiatric and neurological populations. Despite these findings, substantial knowledge gaps remain regarding the effects of tES, particularly in the context of complex, operationally relevant tasks.
Existing research has primarily focused on the effects of tES on simple cognitive tasks, with limited investigation into task that require multiple cognitive domain to operate simultaneously. Performance on complex tasks, such as those involving motor coordination, visual-spatial process, decision-making, and rapid response, may respond differently to tES than simple, isolated tasks. Understanding these effects could have broad applications in optimizing cognitive performance across various high-demand settings.
This study is designed to address several key uncertainties:
- Inter-individual variability in behavioral and neurophysiological responses to tES.
- the impact of stimulation parameters (location, type, intensity) on task performance.
- The magnitude and duration of both immediate and post-stimulation effects on behavior.
To investigate these questions, healthy adults perform a computerized track-and-capture task requiring real-time motor control and decision-making using dual-hand controllers. Participants undergo both active and sham stimulation in a randomized, double-blind, crossover design. Stimulation will target either the left dorsolateral prefrontal cortex or the left anterior insula, guided by current flow modeling software. Performance is assessed during stimulation, immediately after, and at 24 and 48 hours post-stimulation to evaluate both immediate and short-term after-effects.
Outcome measures include task performance metrics (e.g., speed, accuracy, overall success) and neurophysiological data collected via non-invasive monitoring with functional near-infrared spectroscopy (fNIRS). The study is part of a broader research effort to characterize the functional impact of tES on complex behavior and to inform future applications in cognitive performance enhancement.
All stimulation procedures follow established safety guidelines for low-intensity tES, including continuous monitoring of electrode impedance and post-session adverse event questionnaires assessing discomfort, mood, and cognitive status. The Soterix Medical MXN-33 HD-tES system includes built-in safeguards to prevent excessive current delivery and to ensure safe electrode contact throughout the stimulation. Participants serve as their own controls in a within-subject crossover design, increasing statistical power for detecting within-subject differences between active and sham conditions.
- Conditions
- Healthy, Brain Stimulation, Transcranial Direct Current Stimulation (tDCS), Cognition, Psychomotor Performance, Neurophysiology
- Being tested
- Active Transcranial Electrical Stimulation, Sham Transcranial Electrical Stimulation
- Keywords
- Transcranial Electrical Stimulation, Non-Invasive Brain Stimulation, Neuromodulation, Sham-Controlled Study, Double-Blind Study, Cognitive Enhancement, Working Memory, Attention, Learning and Memory, Task Performance, Human Performance, Operational Performance, Neurocognitive Function, Brain-Behavior Relationships, Dorsolateral Prefrontal Cortex, Anterior Insula, Neuronal Excitability, Functional Near-Infrared Spectroscopy (fNIRS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial Electrical StimulationDevice
Active tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation.
Sham Transcranial Electrical StimulationDevice
Sham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions.
| Study group | Role | What they receive |
|---|---|---|
| DLPFC Stimulation Group | Experimental | Participants receive transcranial electrical stimulation (tES) targeting the left dorsolateral prefrontal cortex (DLPFC) and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design. Receives: Device: Active Transcranial Electrical Stimulation; Device: Sham Transcranial Electrical Stimulation |
| Anterior Insula Stimulation Group | Experimental | Participants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design. Receives: Device: Active Transcranial Electrical Stimulation; Device: Sham Transcranial Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROBoT-r Task Performance Score (During Stimulation)
Performance on the ROBoT-r computerized track-and-capture task assessed using a weighted performance score that integrates accuracy, speed, and task success metrics. Scores are scaled from 0 to 100, with higher scores indicating better performance. Participants used dual-hand controllers to grapple a simulated spacecraft in a time-limited, physics-based environment. Performance was assessed during task execution concurrent with stimulation.
Measured: 5 minutes after stimulation onset
ROBoT-r Task Performance Score (Post-Stimulation)
Performance on the ROBoT-r task 15 minutes after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
Measured: 15 minutes post stimulation
ROBoT-r Task Performance Score (Post-Stimulation Follow-up)
Performance on ROBoT-r task at 24 and 48 hours after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
Measured: 24 and 48 hours post-stimulation
Secondary outcomes (2)
tES Adverse Effects Questionnaire
Self-reported adverse effects were recorded immediately following the 45-minute stimulation. Participants reported common stimulation-related sensations (e.g., tingling, scalp pain, itching, burning, headache). Effects were recorded for both active and sham stimulation conditions.
Measured: Immediately following each stimulation session (active and sham), up to approximately 45 minutes per session.
fNIRS Data Availability
Functional near-infrared spectroscopy (fNIRS) data were collected during task performance. This outcome reports the number of participants with usable fNIRS data available within each stimulation location group. Hemodynamic activation analyses are not reported here and may be provided in a future update.
Measured: Throughout study sessions when fNIRS was collected (during stimulation and post-stimulation follow-ups).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Dec 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized to one of two stimulation location groups: (1) left dorsolateral prefrontal cortex (DLPFC) or (2) left anterior insula (L-aINS). Randomization is valances based on gender, age, and video gaming experience. Within each group, participants undergo a crossover design in which they receive both active and sham transcranial electrical stimulation (tES) in randomized order. This design allows for within-subject comparisons between stimulation conditions while assessing the impact of stimulation site on task performance.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary E. Strangman, Massachusetts General Hospital
- Investigators
- Gary Strangman, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995560
- Sponsor's protocol ID
- 2020P002253
- Other IDs
- NNX16AO30G
- Acronym
- BRAIN-STIM
- Status last verified
- May 2026
- First submitted
- 13 May 2025
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD from this project will be anonymized IPD and shared. Data will be coded with a key only available to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Investigations of Transcranial Electrical Stimulation Effects on Neurophysiology and Behavior
- ClinicalTrials.gov ID
- NCT06995560
- Acronym / sponsor ID
- BRAIN-STIM / 2020P002253
- Conditions
- Healthy, Brain Stimulation, Transcranial Direct Current Stimulation (tDCS), Cognition, Psychomotor Performance, Neurophysiology
- Keywords
- Transcranial Electrical Stimulation, Non-Invasive Brain Stimulation, Neuromodulation, Sham-Controlled Study, Double-Blind Study, Cognitive Enhancement, Working Memory, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this randomized, double-blind, sham-controlled, crossover study is to evaluate the effects of transcranial electrical stimulation (tES) on complex cognitive task performance in healthy adult volunteers.
The primary questions this study aims to answer are:
- Does tES improve task performance, including speed, accuracy, and overall success, during a computerized track-and-capture task?
- Do different stimulation targets produce differential effects on performance?
- Are there short-term post-stimulation effects on task performance (up to 48 hours)?
Participants will:
- Complete two testing sessions under either active or sham stimulation conditions.
- Perform a complex operational task involving dual-hand controllers while undergoing tES or sham stimulation, and immediately after.
- Return for follow-up task performance assessments at 24 and 48 hours post-stimulation to evaluate after-effects.
Detailed description
Transcranial electrical stimulation (tES) is a non-invasive neuromodulation technique that delivers low-intensity electrical currents (e.g., <2 mA) through scalp electrodes to modulate brain activity. Numerous studies have shown that tES can enhance cognitive functions such as learning, memory, attention, and decision-making in healthy individuals, as well as provide therapeutic benefits in psychiatric and neurological populations. Despite these findings, substantial knowledge gaps remain regarding the effects of tES, particularly in the context of complex, operationally relevant tasks.
Existing research has primarily focused on the effects of tES on simple cognitive tasks, with limited investigation into task that require multiple cognitive domain to operate simultaneously. Performance on complex tasks, such as those involving motor coordination, visual-spatial process, decision-making, and rapid response, may respond differently to tES than simple, isolated tasks. Understanding these effects could have broad applications in optimizing cognitive performance across various high-demand settings.
This study is designed to address several key uncertainties:
- Inter-individual variability in behavioral and neurophysiological responses to tES.
- the impact of stimulation parameters (location, type, intensity) on task performance.
- The magnitude and duration of both immediate and post-stimulation effects on behavior.
To investigate these questions, healthy adults perform a computerized track-and-capture task requiring real-time motor control and decision-making using dual-hand controllers. Participants undergo both active and sham stimulation in a randomized, double-blind, crossover design. Stimulation will target either the left dorsolateral prefrontal cortex or the left anterior insula, guided by current flow modeling software. Performance is assessed during stimulation, immediately after, and at 24 and 48 hours post-stimulation to evaluate both immediate and short-term after-effects.
Outcome measures include task performance metrics (e.g., speed, accuracy, overall success) and neurophysiological data collected via non-invasive monitoring with functional near-infrared spectroscopy (fNIRS). The study is part of a broader research effort to characterize the functional impact of tES on complex behavior and to inform future applications in cognitive performance enhancement.
All stimulation procedures follow established safety guidelines for low-intensity tES, including continuous monitoring of electrode impedance and post-session adverse event questionnaires assessing discomfort, mood, and cognitive status. The Soterix Medical MXN-33 HD-tES system includes built-in safeguards to prevent excessive current delivery and to ensure safe electrode contact throughout the stimulation. Participants serve as their own controls in a within-subject crossover design, increasing statistical power for detecting within-subject differences between active and sham conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized to one of two stimulation location groups: (1) left dorsolateral prefrontal cortex (DLPFC) or (2) left anterior insula (L-aINS). Randomization is valances based on gender, age, and video gaming experience. Within each group, participants undergo a crossover design in which they receive both active and sham transcranial electrical stimulation (tES) in randomized order. This design allows for within-subject comparisons between stimulation conditions while assessing the impact of stimulation site on task performance.
| Arm | Type | Receives |
|---|---|---|
| DLPFC Stimulation Group | Experimental | Device: Active Transcranial Electrical Stimulation, Device: Sham Transcranial Electrical StimulationParticipants receive transcranial electrical stimulation (tES) targeting the left dorsolateral prefrontal cortex (DLPFC) and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design. |
| Anterior Insula Stimulation Group | Experimental | Device: Active Transcranial Electrical Stimulation, Device: Sham Transcranial Electrical StimulationParticipants receive transcranial electrical stimulation (tES) targeting the left anterior insula and perform a complex cognitive-motor task using the Robotic On-Board Trainer for Research (ROBoT-r) under both active and sham stimulation in a randomized, crossover design. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 25 to 55 years
- Master's or Doctorate degree, or equivalent relevant experience
- No history of head injury or neurological or psychiatric disorders
- No history of cardiac disease
- No metal implants in the head
Key exclusion criteria (5 listed)
- Smoking within the past year
- Current illegal drug use
- Alcohol abuse
- Pregnancy (confirmed by urine test)
- Participation in another brain stimulation protocol within the past month
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 |
|---|---|---|
| Active Transcranial Electrical StimulationActive tES delivered using the Soterix Medical MXN-33 HD-tES stimulator. Stimulation is applied via high definition electrodes targeting either the left DLPFC or L-aINS at intensities up to 1.9 mA. Stimulation is performed for up to 45 minutes during task execution. Participants perform the ROBoT-r task during stimulation. | Device | Anterior Insula Stimulation Group, DLPFC Stimulation Group |
| Sham Transcranial Electrical StimulationSham tES using the same Soterix Medical MXN-33 HD-tES stimulator and electrode placements. Stimulation ramps up and down over 20 seconds to mimic sensation but provides no continuous current. Participants perform the ROBoT-R task under sham conditions. | Device | Anterior Insula Stimulation Group, DLPFC Stimulation Group |
Primary outcome
ROBoT-r Task Performance Score (During Stimulation)
Time frame: 5 minutes after stimulation onset
Performance on the ROBoT-r computerized track-and-capture task assessed using a weighted performance score that integrates accuracy, speed, and task success metrics. Scores are scaled from 0 to 100, with higher scores indicating better performance. Participants used dual-hand controllers to grapple a simulated spacecraft in a time-limited, physics-based environment. Performance was assessed during task execution concurrent with stimulation.
ROBoT-r Task Performance Score (Post-Stimulation)
Time frame: 15 minutes post stimulation
Performance on the ROBoT-r task 15 minutes after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
ROBoT-r Task Performance Score (Post-Stimulation Follow-up)
Time frame: 24 and 48 hours post-stimulation
Performance on ROBoT-r task at 24 and 48 hours after completion of tES. Performance is quantified using a weighted composite score. Scores range from 0 to 100, with higher scores indicating better overall task performance.
2 secondary outcomes
tES Adverse Effects Questionnaire
Time frame: Immediately following each stimulation session (active and sham), up to approximately 45 minutes per session.
fNIRS Data Availability
Time frame: Throughout study sessions when fNIRS was collected (during stimulation and post-stimulation follow-ups).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All IPD from this project will be anonymized IPD and shared. Data will be coded with a key only available to the Principal Investigator.
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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.
Gary Strangman, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Electrical Stimulation in people with Healthy and Brain Stimulation, run by Massachusetts General Hospital 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 8 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 15 May 2026. 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. 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 15 May 2026). 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?
ROBoT-r Task Performance Score (During Stimulation) (time frame: 5 minutes after stimulation onset). The study lists 3 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 15 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.