Parkinson DiseaseNCT06324448
Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD
A study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2024to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Transcranial direct current stimulation
- Keywords
- Parkinson Disease, transcranial direct current stimulation, gait, dual-task
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
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)).
| Study group | Role | What they receive |
|---|---|---|
| Primary motor cortex | Experimental | 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. Receives: Device: Transcranial direct current stimulation |
| Left dorsolateral prefrontal cortex | Experimental | 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. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed-up and go test (sec)
Measured: Immediate post-intervention
Timed-up and go test under dual-task condition (sec)
Measured: Immediate post-intervention
Secondary outcomes (18)
Dual-task effect (%) in Timed-up and go test
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]
Measured: Immediate post-intervention
modified Attention Allocation Index (mAAI) in Timed-up and go test
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Measured: Immediate post-intervention
Gait parameters
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
Measured: Immediate post-intervention
Single-leg stance test
Measured: Immediate post-intervention
Stroop test
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Measured: Immediate post-intervention
Trail making test
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Measured: Immediate post-intervention
New freezing of gait questionnaire (NFoGQ)
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Measured: Immediate post-intervention
Geriatric depression scale (GDS)-short form
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Measured: Immediate post-intervention
Timed-up and go test (sec)
Measured: Follow-up (1 month)
Timed-up and go test under dual-task condition (sec)
Measured: Follow-up (1 month)
Dual-task effect (%) in Timed-up and go test
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]
Measured: Follow-up (1 month)
modified Attention Allocation Index (mAAI) in Timed-up and go test
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Measured: Follow-up (1 month)
Gait parameters
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
Measured: Follow-up (1 month)
Single-leg stance test
Measured: Follow-up (1 month)
Stroop test
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Measured: Follow-up (1 month)
Trail making test
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Measured: Follow-up (1 month)
New freezing of gait questionnaire (NFoGQ)
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Measured: Follow-up (1 month)
Geriatric depression scale (GDS)-short form
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Measured: Follow-up (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start15 Feb 2024
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han Gil Seo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06324448
- Sponsor's protocol ID
- PD-tDCS-RCT
- Status last verified
- Apr 2026
- First submitted
- 13 Mar 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06324448
- Acronym / sponsor ID
- PD-tDCS-RCT
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, transcranial direct current stimulation, gait, dual-task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Primary motor cortex | Experimental | Device: Transcranial direct current stimulationThe 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. |
| Left dorsolateral prefrontal cortex | Experimental | Device: Transcranial direct current stimulationThe 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationtDCS 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)). | Device | Left dorsolateral prefrontal cortex, Primary motor cortex |
Primary outcome
Timed-up and go test (sec)
Time frame: Immediate post-intervention
Timed-up and go test under dual-task condition (sec)
Time frame: Immediate post-intervention
18 secondary outcomes
Dual-task effect (%) in Timed-up and go test
Time frame: Immediate post-intervention
modified Attention Allocation Index (mAAI) in Timed-up and go test
Time frame: Immediate post-intervention
Gait parameters
Time frame: Immediate post-intervention
Single-leg stance test
Time frame: Immediate post-intervention
Stroop test
Time frame: Immediate post-intervention
Trail making test
Time frame: Immediate post-intervention
New freezing of gait questionnaire (NFoGQ)
Time frame: Immediate post-intervention
Geriatric depression scale (GDS)-short form
Time frame: Immediate post-intervention
Timed-up and go test (sec)
Time frame: Follow-up (1 month)
Timed-up and go test under dual-task condition (sec)
Time frame: Follow-up (1 month)
Dual-task effect (%) in Timed-up and go test
Time frame: Follow-up (1 month)
modified Attention Allocation Index (mAAI) in Timed-up and go test
Time frame: Follow-up (1 month)
Gait parameters
Time frame: Follow-up (1 month)
Single-leg stance test
Time frame: Follow-up (1 month)
Stroop test
Time frame: Follow-up (1 month)
Trail making test
Time frame: Follow-up (1 month)
New freezing of gait questionnaire (NFoGQ)
Time frame: Follow-up (1 month)
Geriatric depression scale (GDS)-short form
Time frame: Follow-up (1 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Parkinson Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed-up and go test (sec) (time frame: Immediate post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.