search
Back to results

tDCS for Dual-task Performance in Patients With PD

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, transcranial direct current stimulation, dual-task performance

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

Primary motor cortex

Left dorsolateral prefrontal cortex

Ventromedial prefrontal cortex

Sham stimulation

Arm Description

The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode 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.

The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode 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.

The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). 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.

The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.

Outcomes

Primary Outcome Measures

Cognitive dual-task interference (%) in Timed-up & go test
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]
Physical dual-task interference (%) in Timed-up & go test
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 Outcome Measures

Timed-up & go test (sec): single task
Timed-up & go test (sec): cognitive dual-task
Timed-up & go test (sec): physical dual-task
Stroop test
Trail making test
Digit span test

Full Information

First Posted
August 5, 2020
Last Updated
April 10, 2023
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04504422
Brief Title
tDCS for Dual-task Performance in Patients With PD
Official Title
Transcranial Direct Current Stimulation to Improve Dual-task Performance in Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Explorative Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
July 4, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, transcranial direct current stimulation, dual-task performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Primary motor cortex
Arm Type
Experimental
Arm Description
The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode 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.
Arm Title
Left dorsolateral prefrontal cortex
Arm Type
Experimental
Arm Description
The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode 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.
Arm Title
Ventromedial prefrontal cortex
Arm Type
Experimental
Arm Description
The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). 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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).
Primary Outcome Measure Information:
Title
Cognitive dual-task interference (%) in Timed-up & go test
Description
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]
Time Frame
Immediately after a 20-minute tDCS session
Title
Physical dual-task interference (%) in Timed-up & go test
Description
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]
Time Frame
Immediately after a 20-minute tDCS session
Secondary Outcome Measure Information:
Title
Timed-up & go test (sec): single task
Time Frame
Immediately after a 20-minute tDCS session
Title
Timed-up & go test (sec): cognitive dual-task
Time Frame
Immediately after a 20-minute tDCS session
Title
Timed-up & go test (sec): physical dual-task
Time Frame
Immediately after a 20-minute tDCS session
Title
Stroop test
Time Frame
Immediately after a 20-minute tDCS session
Title
Trail making test
Time Frame
Immediately after a 20-minute tDCS session
Title
Digit span test
Time Frame
Immediately after a 20-minute tDCS session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han Gil Seo, MD, PhD
Phone
82-2-2072-1659
Email
hgseo80@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Han Gil Seo, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Gil Seo, MD
Phone
82-2-2072-1659
Email
hgseo80@gmail.com

12. IPD Sharing Statement

Learn more about this trial

tDCS for Dual-task Performance in Patients With PD

We'll reach out to this number within 24 hrs