NCT06039605

Brief Summary

The purpose of this study is to test if priming expectations of transcranial Direct Current Stimulation (tDCS) can improve the efficacy of tDCS in enhancing motor learning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2025

Completed
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

August 30, 2023

Last Update Submit

August 19, 2025

Conditions

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

  • Performance on motor task one week after final training session

    This will be calculated as the average of two trials of the motor task that are completed one week after the last training session, after controlling for baseline. The motor task is a timed test that requires participants to spoon two beans (kidney, raw) at a time from a center proximal "start" cup to three distal "target" cups as fast as possible. In short, this task requires multijoint coordination and limb reversal, and performance for each trial is measured in seconds.

    Change from Baseline to One-Week Follow Up visit (10 days)

Secondary Outcomes (6)

  • Change in motor performance over the course of training

    Three days

  • Change in tDCS expectations from Day 1 to Day 7

    7 days

  • Average dwell time

    10 days

  • Average peak reach velocity

    10 days

  • Variability in transcranial direct current stimulation expectations

    10 days

  • +1 more secondary outcomes

Study Arms (4)

Control

NO INTERVENTION

This group will only receive motor training, which consists of 10 trials of motor training per day across 3 days, followed by a one-week follow-up of 2 trials.

tDCS1

EXPERIMENTAL

This group will receive motor training concurrent with 20 minutes of either sham or active tDCS. Sham tDCS will be a 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. The next 18 minutes will have no stimulation (0 mA), starting at minute 19 with 30-second ramp up from 0 to 2 milliamps (MA), then a 30-second ramp-down from 2 mA to 0 mA. Active tDCS will ramp up to 2 mA in the first 30 seconds, then stay at 2 mA for 19 minutes, then ramp down to 0 mA.

Device: Transcranial Direct Current Stimulation

tDCS2

EXPERIMENTAL

This group will first read some information about tDCS based on cited studies. They will then receive the same motor training and tDCS as the tDCS1 arm.

Device: Transcranial Direct Current Stimulation

tDCS3

EXPERIMENTAL

This group will first read some information about tDCS based on cited studies, but different cited studies than the tDCS2 arm. They will then receive the same motor training and tDCS as the tDCS1 and 2 arms.

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation (tDCS) is a minimal risk, non-invasive, neuromodulatory technique that involves the emission of a weak electrical current, traditionally via the placement of two electrodes attached to the scalp of a participant. tDCS is widely used for research purposes, the US FDA considers trials of tDCS as non-significant-risk. There are several review articles supporting the safety of tDCS usage in controlled human trials. According to a published meta-analysis , the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions.

Also known as: tDCS
tDCS1tDCS2tDCS3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 or older. Right-hand dominant
  • Right-hand dominant

You may not qualify if:

  • Mixed-handed or ambidextrous
  • Left-hand dominant
  • Seizure(s)
  • Head injury resulting in a loss of consciousness that has required further investigation (including neurosurgery)
  • Migraines
  • Current medical diagnosis of a phycological or neurological condition
  • Any metal in head (outside of mouth) such as shrapnel or surgical clips
  • Any implanted devices (e.g. cardiac pacemaker, brain stimulator)
  • Skin condition on scalp (e.g. psoriasis)
  • Head wound that has not completely healed
  • Adverse reactions to tDCS or any other brain stimulation technique (e.g. TMS, tRNS)
  • Pregnant
  • Currently taking prescription medications or are self-medicating (including recreational drug use), other than the contraceptive pill?

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Tempe, Arizona, 85281, United States

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Sydney Schaefer, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Participants and Research Assistants will be blinded to the groups/treatment conditions unless the participant is a "control". The investigator and/or research administration team will screen, enroll and assign participants to groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of 4 groups: control, tDCS1, tDCS2, or tDCS3.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 15, 2023

Study Start

October 23, 2023

Primary Completion

April 16, 2025

Study Completion

April 16, 2025

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be provided.

Locations