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Completed

NCT Number: NCT06324448

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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)).

Primary outcomes

  1. Timed-up and go test (sec)

    Time frame: Immediate post-intervention

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

    Time frame: Immediate post-intervention

Secondary outcomes

  1. 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]

  2. 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)

  3. 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

  4. Single-leg stance test

    Time frame: Immediate post-intervention

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Timed-up and go test (sec)

    Time frame: Follow-up (1 month)

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

    Time frame: Follow-up (1 month)

  11. 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]

  12. 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)

  13. 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

  14. Single-leg stance test

    Time frame: Follow-up (1 month)

  15. 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.

  16. 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.

  17. 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.

  18. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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