NCT06324448

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable parkinson-disease

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

Study Start

First participant enrolled

February 15, 2024

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2026

Completed
Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

March 13, 2024

Last Update Submit

April 22, 2026

Conditions

Parkinson Disease

Keywords

Parkinson Diseasetranscranial direct current stimulationgaitdual-task

Outcome Measures

Primary Outcomes (2)

  • Timed-up and go test (sec)

    Immediate post-intervention

  • Timed-up and go test under dual-task condition (sec)

    Immediate post-intervention

Secondary Outcomes (18)

  • Dual-task effect (%) in Timed-up and go test

    Immediate post-intervention

  • modified Attention Allocation Index (mAAI) in Timed-up and go test

    Immediate post-intervention

  • Gait parameters

    Immediate post-intervention

  • Single-leg stance test

    Immediate post-intervention

  • Stroop test

    Immediate post-intervention

  • +13 more secondary outcomes

Study Arms (2)

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.

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.

Device: Transcranial direct current stimulation

Interventions

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)).

Left dorsolateral prefrontal cortexPrimary motor cortex

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 13, 2024

First Posted

March 22, 2024

Study Start

February 15, 2024

Primary Completion

February 24, 2026

Study Completion

February 24, 2026

Last Updated

April 27, 2026

Record last verified: 2026-04

Locations

KR(1)