Effects of Transcranial Electrical Stimulation on Task Performance in Healthy Adults

NCT06995560 | Completed FDA Device

• 2 other identifiers: 2020P002253NNX16AO30G
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does tES improve task performance, including speed, accuracy, and overall success, during a computerized track-and-capture task?
2. 2.Do different stimulation targets produce differential effects on performance?
3. 3.Are there short-term post-stimulation effects on task performance (up to 48 hours)?
4. 4.Complete two testing sessions under either active or sham stimulation conditions.
5. 5.Perform a complex operational task involving dual-hand controllers while undergoing tES or sham stimulation, and immediately after.
6. 6.Return for follow-up task performance assessments at 24 and 48 hours post-stimulation to evaluate after-effects.

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; 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)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  24 and 48 hours post-stimulation

Secondary Outcomes (2)

• tES Adverse Effects Questionnaire

  Immediately after each stimulation session

• Hemodynamic Activation (HbD) - fNIRS

  Post stimulation/sham and during post-stimulation session (24 and 48 hours)

Study Arms (2)

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.

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.

Device: Active Transcranial Electrical Stimulation; Device: Sham Transcranial Electrical Stimulation

Interventions

Active Transcranial Electrical Stimulation DEVICE

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.

Anterior Insula Stimulation Group; DLPFC Stimulation Group

Sham Transcranial Electrical Stimulation DEVICE

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.

Anterior Insula Stimulation Group; DLPFC Stimulation Group

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Smoking within the past year
• Current illegal drug use
• Alcohol abuse
• Pregnancy (confirmed by urine test)
• Participation in another brain stimulation protocol withing the past month

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Research Institute

Charlestown, Massachusetts, 02129, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators were blinded to stimulation conditions (active vs. sham) and to which pre-programmed stimulation protocol (A or B) corresponded to active stimulation. The investigator was aware of the assigned stimulation location (DLPFC or L-aINS), but not whether stimulation protocol A or B was active or sham. The tES device was operated in double-blind model, with stimulation order randomized.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 29, 2025
• Study Start: October 25, 2020
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be made available by the end-date of the funded project (estimated 12/25/2025) and retained indefinitely.
• Access Criteria: Researchers will be allowed to request the data form the NASA NLSP through their website https://nlsp.nasa.gov/explore/page/home. NASA will be responsible for vetting requests and providing the data as requested.

Locations

US (1)