Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD

April 22, 2026 updated by: Han Gil Seo, Seoul National University Hospital

Self-administered Transcranial Direct Current Stimulation for Improving Single- and Dual-task Gait in Patients With Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Exploratory, Randomized Controlled Trial

The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Dual-task performance involves a complex interplay of motor functions as well as cognitive functions such as attention and executive function. One way to potentially reduce the cost of dual-tasking and the negative effects of motor-cognitive interference is to consider improving the corresponding component, i.e., motor or cognitive function.

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that can be used to change cortical activity. Recently, there has been growing attention on tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have reported the positive results of tDCS on motor and cognitive function. Most studies have examined changes before and after a single session of stimulation, with limited research verifying the cumulative and long-term effects of tDCS. Therefore, this study aims to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with PD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically diagnosed as idiopathic Parkinson's disease by neurologists according to the UK Parkinson's Disease Society Brain Bank criteria
  • modified Hoehn & Yahr stage 2, 2.5, or 3

Exclusion Criteria:

  • History of seizure
  • Metallic implants, such as cardiac pacemaker or an artificial cochlea
  • Patients with inflammation, burns, or wounds in the stimulation area
  • Parkinson's disease dementia; cut-off is < 7 of Korean-Montreal Cognitive Assessment for illiterate patients, < 13 for those educated for 0.5-3 years, < 16 for 4-6 years of education, < 19 for 7-9 years of education, and < 20 for 10 or more years of education.
  • Severe dyskinesia or severe on-off phenomenon
  • Plan to adjust medication at the time of screening
  • Other neurological, orthopedic, or cardiovascular co-morbidities significantly affecting gait function
  • Uncontrolled vestibular disease, orthopedic hypotension, or paroxysmal vertigo
  • Pregnant or lactating patients
  • Other comorbidities that make it difficult to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Primary motor cortex
The anodal electrode is positioned in the primary motor cortex (Cz) and the cathodal electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
Device: Transcranial direct current stimulation
tDCS self-administered at home once a day for 28 consecutive days for a total of 28 sessions (one session consists of 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea)).
Experimental: Left dorsolateral prefrontal cortex
The anodal electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathodal electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
Device: Transcranial direct current stimulation
tDCS self-administered at home once a day for 28 consecutive days for a total of 28 sessions (one session consists of 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea)).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Timed-up and go test (sec)
Time Frame: Immediate post-intervention
Immediate post-intervention
Timed-up and go test under dual-task condition (sec)
Time Frame: Immediate post-intervention
Immediate post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dual-task effect (%) in Timed-up and go test
Time Frame: Immediate post-intervention
Percentage of dual-task effect calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]
Immediate post-intervention
modified Attention Allocation Index (mAAI) in Timed-up and go test
Time Frame: Immediate post-intervention
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Immediate post-intervention
Single-leg stance test
Time Frame: Immediate post-intervention
Immediate post-intervention
Timed-up and go test (sec)
Time Frame: Follow-up (1 month)
Follow-up (1 month)
Timed-up and go test under dual-task condition (sec)
Time Frame: Follow-up (1 month)
Follow-up (1 month)
Dual-task effect (%) in Timed-up and go test
Time Frame: Follow-up (1 month)
Percentage of dual-task effect calculated by the difference between dual-task and single-task performance [Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance]
Follow-up (1 month)
modified Attention Allocation Index (mAAI) in Timed-up and go test
Time Frame: Follow-up (1 month)
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Follow-up (1 month)
Single-leg stance test
Time Frame: Follow-up (1 month)
Follow-up (1 month)
Gait parameters
Time Frame: Immediate post-intervention
Symmetric temporospatial parameters, Normal cadence, Decreased & intolerable walking velocity, Normal step length differential, Normal step length on both sides, Normal stride length on both sides, Normal swing phase & stance phase on both sides, Normal single support time & double support time on both sides, Slightly widened base of support on both sides, Increased foot angle on right side
Immediate post-intervention
Stroop test
Time Frame: Immediate post-intervention
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Immediate post-intervention
Trail making test
Time Frame: Immediate post-intervention
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Immediate post-intervention
New freezing of gait questionnaire (NFoGQ)
Time Frame: Immediate post-intervention
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Immediate post-intervention
Geriatric depression scale (GDS)-short form
Time Frame: Immediate post-intervention
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Immediate post-intervention
Gait parameters
Time Frame: Follow-up (1 month)
Symmetric temporospatial parameters, Normal cadence, Decreased & intolerable walking velocity, Normal step length differential, Normal step length on both sides, Normal stride length on both sides, Normal swing phase & stance phase on both sides, Normal single support time & double support time on both sides, Slightly widened base of support on both sides, Increased foot angle on right side
Follow-up (1 month)
Stroop test
Time Frame: Follow-up (1 month)
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Follow-up (1 month)
Trail making test
Time Frame: Follow-up (1 month)
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Follow-up (1 month)
New freezing of gait questionnaire (NFoGQ)
Time Frame: Follow-up (1 month)
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Follow-up (1 month)
Geriatric depression scale (GDS)-short form
Time Frame: Follow-up (1 month)
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Follow-up (1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PD-tDCS-RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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