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.
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: 1. Inter-individual variability in behavioral and neurophysiological responses to tES. 2. the impact of stimulation parameters (location, type, intensity) on task performance. 3. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
40
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.
Massachusetts General Hospital Research Institute
Charlestown, Massachusetts, United States
ROBoT-r Task Performance Score (During Stimulation)
Performance on a computerized track-and-capture task assessed via a weighted score combining accuracy, speed, and success rate. Participants use dual-hand controllers to grapple a simulated spacecraft in a time-limited, physics-enabled environment. Scores from 0 to 10, with higher scores indicating better performance. Task begins 5 minutes after stimulation onset.
Time frame: 5 minutes after stimulation onset
ROBoT-r Task Performance Score (Post-Stimulation)
Performance On ROBoT-r task 15 minutes post-stimulation. Scored using the same weighted score (0 to 10) combining accuracy, speed, and success rate.
Time frame: 15 minutes post stimulation
ROBoT-r Task Performance Score (Post-Stimulation Follow-up)
Performance on ROBoT-r task at 24 and 48 hours post-stimulation to assess short-term after-effects. Scored using the same weighted score (0 to 10) combining accuracy, speed, and success rate.
Time frame: 24 and 48 hours post-stimulation
tES Adverse Effects Questionnaire
Self-reported adverse effects following tES session, including measures of tingling, headache, fatigue, mood changes, and skin irritation. Participants rate presence and severity of effects using standardized questionnaire.
Time frame: Immediately after each stimulation session
Hemodynamic Activation (HbD) - fNIRS
Hemodynamic brain activity measured using functional near-infrared spectroscopy (fNIRS) via the NINscan system, which was designed and built at Massachusetts General Hospital for research purposes. The NINscan system uses four dual-wavelength laser diode sources (780 nm, 830 nm) and eight photodiode detectors sampled at 250 Hz, with a 64-channel source-detector configuration. Selected channels for analysis include the left lateral, medial, and right lateral regions of the prefrontal cortex. Hemodynamic activation indexed by HbD (ΔO2Hb - ΔHHb) concentration, reflecting changes in cortical oxygenation associated with neural activation.
Time frame: Post stimulation/sham and during post-stimulation session (24 and 48 hours)
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