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Completed

NCT Number: NCT04504422

tDCS for Dual-task Performance in Patients With PD

The purpose of this study is to investigate the optimal stimulation location of transcranial direct current stimulation to improve the dual-task performance 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. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.

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 function. However, few studies have reported the therapeutic effect of tDCS on the dual-task performance in PD. In addition, inconsistent results have been reported because tDCS protocol has been applied in various way. Therefore, this study aims to investigate an optimized stimulation site of tDCS that could improve the dual-task performance 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
  • 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
  • Sensory abnormalities of the lower extremities, other neurological or orthopedic disease affecting lower extremities, or severe cardiovascular diseases
  • Vestibular disease 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 (tDCS)

Device

tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).

Primary outcomes

  1. Cognitive dual-task interference (%) in Timed-up & go test

    Time frame: Immediately after a 20-minute tDCS session

    Percentage of dual-task interference 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. Physical dual-task interference (%) in Timed-up & go test

    Time frame: Immediately after a 20-minute tDCS session

    Percentage of dual-task interference 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]

Secondary outcomes

  1. Timed-up & go test (sec): single task

    Time frame: Immediately after a 20-minute tDCS session

  2. Timed-up & go test (sec): cognitive dual-task

    Time frame: Immediately after a 20-minute tDCS session

  3. Timed-up & go test (sec): physical dual-task

    Time frame: Immediately after a 20-minute tDCS session

  4. Stroop test

    Time frame: Immediately after a 20-minute tDCS session

  5. Trail making test

    Time frame: Immediately after a 20-minute tDCS session

  6. Digit span test

    Time frame: Immediately after a 20-minute tDCS session

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Transcranial Direct Current Stimulation to Improve Dual-task Performance in Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Explorative Clinical Trial

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2020
Registry last updated
Feb 20, 2024

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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