Massachusetts General Hospital Research Institute
Charlestown, Massachusetts, 02129, United States
NCT Number: NCT06995560
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. Does tES improve task performance, including speed, accuracy, and overall success, during a computerized track-and-capture task? 2. Do different stimulation targets produce differential effects on performance? 3. Are there short-term post-stimulation effects on task performance (up to 48 hours)?
Participants will:
1. Complete two testing sessions under either active or sham stimulation conditions. 2. Perform a complex operational task involving dual-hand controllers while undergoing tES or sham stimulation, and immediately after. 3. Return for follow-up task performance assessments at 24 and 48 hours post-stimulation to evaluate after-effects.
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Notify Me25 year–55 year
All sexes
Interventional
Not applicable
Charlestown, Massachusetts, 02129, United States
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
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.
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.
Time frame: Immediately following each stimulation session (active and sham), up to approximately 45 minutes per session.
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.
Time frame: Throughout study sessions when fNIRS was collected (during stimulation and post-stimulation follow-ups).
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.
Massachusetts General Hospital
Other
Preliminary Investigations of Transcranial Electrical Stimulation Effects on Neurophysiology and Behavior
Acronym: BRAIN-STIM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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