Back to resultsApplication of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Brain stimulation
Treadmill gait training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring transcranial direct current stimulation, gait training, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Age: 50 - 75 years
- Modified Hoehn and Yahr stages 1 to 4
Exclusion Criteria:
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
- History of psychiatric disease
- Implanted objects that would contraindicate tDCS
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Gait training with brain stimulation
Gait training with sham brain stimulation
Arm Description
Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas
Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas
Outcomes
Primary Outcome Measures
Change in 10 meter walk test from baseline in gait speed
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
Secondary Outcome Measures
Change in Berg Balance Scale (BBS) from baseline in balance
Mesure of blance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56.
Change in Timed Up and Go test (TUG) from baseline in balance
Meserue of dynamic blance function. 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Changes in Brain activation of resting-state functional MRI
Meserue of Neuroplasticity
Changes in motor evoked potentia
Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Changes in Functional Reach Test (FRT) from baseline
FRT is a single item test developed as a quick screen for balance problems. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal
Change in muscle manual test (MMT) and range of motion (ROM) from baseline
Meserue of MMT and ROM of lower extremity.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline
Meserue of Parkinson disease motor level.
1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Change in Korean Mini-Mental State Examination (K-MMSE) from baseline
Meserue of cognition level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Change in Geriatric Depression Scale (GDS) from baseline
Meserue of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Full Information
NCT ID
NCT04591236
First Posted
October 15, 2020
Last Updated
February 27, 2023
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04591236
Brief Title
Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
Official Title
The Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Gait Training for Parkinson's Disease Patients on Gait Function Improvement
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
transcranial direct current stimulation, gait training, Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gait training with brain stimulation
Arm Type
Experimental
Arm Description
Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas
Arm Title
Gait training with sham brain stimulation
Arm Type
Active Comparator
Arm Description
Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas
Intervention Type
Device
Intervention Name(s)
Brain stimulation
Intervention Description
tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
Intervention Type
Device
Intervention Name(s)
Treadmill gait training
Intervention Description
Treadmill gait training was applied to Parkinson patients.
Primary Outcome Measure Information:
Title
Change in 10 meter walk test from baseline in gait speed
Description
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary Outcome Measure Information:
Title
Change in Berg Balance Scale (BBS) from baseline in balance
Description
Mesure of blance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Change in Timed Up and Go test (TUG) from baseline in balance
Description
Meserue of dynamic blance function. 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Changes in Brain activation of resting-state functional MRI
Description
Meserue of Neuroplasticity
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks)
Title
Changes in motor evoked potentia
Description
Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Changes in Functional Reach Test (FRT) from baseline
Description
FRT is a single item test developed as a quick screen for balance problems. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Change in muscle manual test (MMT) and range of motion (ROM) from baseline
Description
Meserue of MMT and ROM of lower extremity.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline
Description
Meserue of Parkinson disease motor level.
1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Change in Korean Mini-Mental State Examination (K-MMSE) from baseline
Description
Meserue of cognition level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Title
Change in Geriatric Depression Scale (GDS) from baseline
Description
Meserue of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".
Time Frame
session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 50 - 75 years
Modified Hoehn and Yahr stages 1 to 4
Exclusion Criteria:
Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
History of psychiatric disease
Implanted objects that would contraindicate tDCS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Lee, Ph.D
Organizational Affiliation
yun1225.kim@samsung.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
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