Effects of Transcranial Electrical Stimulation on Task Performance in Healthy Adults

NCT06995560 | Completed Results FDA Device

• 2 other identifiers: 2020P002253NNX16AO30G
• Study Type: interventional
• Target: 44
• 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; Cognition; Psychomotor Performance; Transcranial Direct Current Stimulation (tDCS); 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 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.

  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.

  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.

  24 and 48 hours post-stimulation

Secondary Outcomes (2)

• tES Adverse Effects Questionnaire

  Immediately following each stimulation session (active and sham), up to approximately 45 minutes per session.

• fNIRS Data Availability

  Throughout study sessions when fNIRS was collected (during stimulation and post-stimulation follow-ups).

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 within the past month

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Research Institute

Charlestown, Massachusetts, 02129, United States

Location

Limitations and Caveats

Analyses of secondary fNIRS outcomes are ongoing and are not included.

Results Point of Contact

• Title: Gary Strangman, PhD
• Organization: Massachusetts General Hospital

strang@mgh.harvard.edu

617-724-0662

Study Officials

• Gary Strangman, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 1, 2022
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-05

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)